Sleep DisordersPhase 4NCT00518986
Efficacy and Safety of Armodafinil for Adults With Excessive Sleepiness Obstructive Sleep Apnea/Hypopnea and Depression
A Phase 4 study testing armodafinil in people with Sleep Disorders and Obstructive Sleep Apnea, run by Cephalon at 62 sites in United States.
Trial summary
The primary objective of the study is to evaluate whether armodafinil at a target dosage of 200 mg/day is more effective than placebo treatment in improving excessive sleepiness in patients with obstructive sleep apnea/hypopnea syndrome (OSAHS) who have comorbid major depressive disorder or dysthymic disorder. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Sleep Disorders, Obstructive Sleep Apnea, Major Depressive Disorder
- What is being tested?
- armodafinil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 249 participants
- Where
- 62 sitesUnited States
- Study dates
- Oct 2007to Mar 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Current diagnosis of obstructive sleep apnea/hypopnea syndrome (OSAHS)
- Complaint of residual excessive sleepiness despite nasal continuous positive airway pressure (nCPAP) therapy being effective
- Current or prior diagnosis of major depressive disorder or dysthymic disorder
- Clinically stable with regard to depressed mood and has shown a treatment response to selective serotonin reuptake inhibitor (SSRI) therapy or serotonin and norepinephrine reuptake inhibitor (SNRI) therapy
- Patient has been on a stable monotherapy dose of an allowed SSRI or SNRI for at least 8 weeks at the time of screening
- Women of childbearing potential must use a medically accepted method of contraception.
Who cannot join
- Confirmed or suspected diagnosis of a currently active sleep disorder other than obstructive sleep apnea/hypopnea syndrome (OSAHS)
- Current episode of major depression that is considered to be treatment-resistant
- A primary diagnosis of: eating disorder, psychotic disorder, delirium, dementia, substance-related disorders, or moderate to severe hypochondriasis
- Patient has a history of bipolar disorder, psychotic depression, schizophrenia, schizoaffective disorder, any other psychotic disorder, or other clinically significant uncontrolled psychiatric condition.
- Patient has a history of homicidal ideation or significant aggression
- Patient has a diagnosis of severe antisocial or borderline personality disorder
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- Has a history of significant suicidal ideation, or has current active suicidal ideation, or is considered at imminent risk of self harm.
- Patient has a history consistent with fibromyalgia or chronic fatigue syndrome
- A high consumption of caffeinated products, approximately equivalent to 5 or more cups of coffee per day
- Patient history of any clinically significant cutaneous drug reaction, or a history of clinically significant hypersensitivity reaction
- Has a past or present seizure disorder
- Patient has a history of alcohol, narcotic, or any other substance abuse or dependence (with the exception of nicotine)
- Psychotherapeutic intervention for the patient was initiated within 8 weeks of the screening visit.
- Patient has known human immunodeficiency virus (HIV)
- Patient has any clinically significant uncontrolled medical condition (including illnesses related to the cardiovascular, renal, or hepatic systems) or surgical condition (treated or untreated)
- Patient is a pregnant or lactating woman
- Patient has previously received armodafinil; or, patient has used modafinil or any investigational product within 28 days of the baseline visit.
Trial locations and contacts
62 sites in 1 country.
62 sites in 1 country
United States62 sites
The Sleep Disorders Center
Atlanta, Georgia, 30339
Neurotrials Research, Inc
Atlanta, Georgia, 30342
Sleep Disorders Center of Georgia
Atlanta, Georgia, 30342
FutureSearch Trials of Neurology
Austin, Texas, 78756
Northwest Clinical Research
Bellevue, Washington, 98004
Graves Gilbert Clinic
Bowling Green, Kentucky, 42101
PAB Clinical Research
Brandon, Florida, 33511
Sleep Health Centers
Brighton, Massachusetts, 02135
Brooklyn Medical Institute
Brooklyn, New York, 11223
Lowcountry Lung and Critical Care
Charleston, South Carolina, 29406
The Center for Sleep & Wake Disorders
Chevy Chase, Maryland, 20815
Chicago Research Center
Chicago, Illinois, 60634
Tri-State Sleep Disorders Center
Cincinnati, Ohio, 45246
Sleep Lab of Northeastern PA
Clarks Summit, Pennsylvania, 18411
SleepMed of South Carolina
Columbia, South Carolina, 29201
Community Research
Crestview, Kentucky, 45217
Sleep Medicine Associates of Texas, P.A.
Dallas, Texas, 75231
The Center for Sleep and Wake Disorders
Danville, Indiana, 46122
National Jewish Medical and Research Center
Denver, Colorado, 80206
Ohio Sleep Medicine Institute
Dublin, Ohio, 43017
Duke University Medical Center
Durham, North Carolina, 27710
AccelRx Research
Fall River, Massachusetts, 02721
Behavioral Research Specialists
Glendale, California, 91204
California Clinical Trials Medical Group, Inc.
Glendale, California, 91206
The Center for Sleep Medicine
Hattiesburg, Mississippi, 39406
Clinical Trials of America
Hickory, North Carolina, 28601
Baylor College of Medicine VAMC Sleep Research
Houston, Texas, 77030
Houston Sleep Center
Houston, Texas, 77063
Jasper Summit Research, LLC
Jasper, Alabama, 35501
Somnos Sleep Center
Lincoln, Nebraska, 68510
AccelRx Research
Lincoln, Rhode Island, 02865
SleepMed, Inc
Macon, Georgia, 31201
North Star Medical Research, LLC
Middleburg Heights, Ohio, 44130
Sleep Medicine of Middle Tennessee
Nashville, Tennessee, 37203
Clinilabs, Inc
New York, New York, 10019
Lynn Health Science Institute
Oklahoma City, Oklahoma, 73112
Vince & Associates Clinical Research
Overland Park, Kansas, 66212
Peoria Pulmonary Associates
Peoria, Illinois, 61603
University of Pennsylvania Center for Sleep
Philadelphia, Pennsylvania, 19104
CRI Worldwide
Philadelphia, Pennsylvania, 19139
Pulmonary Associates, P.A.
Phoenix, Arizona, 85012
Psypharma Clinical Research
Phoenix, Arizona, 85050
Pacific Sleep Medicine Services, Inc.
Redlands, California, 92373
Pacific Research Network, Inc.
San Diego, California, 92103
Pacific Sleep Medicine Services, Inc.
San Diego, California, 92121
California Clinical Trials Medical Group, Inc.
San Diego, California, 92123
SDS Clinical Research
Santa Ana, California, 92704
St. Johns Medical Plaza Sleep Disorders Center
Santa Monica, California, 90404
Pacific Sleep Medicine Services, Inc.
Seattle, Washington, 98122
Clinical Trials of America
Shreveport, Louisiana, 71101
Florida Sleep Institute
Spring Hill, Florida, 34609
Washington University
St Louis, Missouri, 63108
Clinical Research Group of St. Petersburg
St. Petersburg, Florida, 33707
SomnoMedics
Tampa, Florida, 33607
Stedman Clinical Trials, LLC
Tampa, Florida, 33613
St. Vincent Mercy Medical Center
Toledo, Ohio, 43606
PsyPharm Clinical Research, Inc.
Tucson, Arizona, 85712
Sleep and Behavior Medicine
Vernon Hills, Illinois, 60061
University Services
West Chester, Pennsylvania, 19380
Sleep Medicine Centers
West Seneca, New York, 14224
Rocky Mountain Center for Clinical Research
Wheat Ridge, Colorado, 80033
Florida Pulmonary Research Center, LLC
Winter Park, Florida, 33613
About this study
Official title: Double-Blind, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of Armodafinil for Adults With Excessive Sleepiness Associated With Obstructive Sleep Apnea/Hypopnea Syndrome With Major Depressive Disorder or Dysthymic Disorder
The primary objective of the study is to evaluate whether armodafinil at a target dosage of 200 mg/day is more effective than placebo treatment in improving excessive sleepiness in patients with obstructive sleep apnea/hypopnea syndrome (OSAHS) who have comorbid major depressive disorder or dysthymic disorder.
- Being tested
- armodafinil, placebo
- Keywords
- Obstructive Sleep Apnea/Hypopnea Syndrome, Excessive Sleepiness
- Medical subject headings
- Sleep Wake Disorders, Sleep Apnea, Obstructive, Depressive Disorder, Major, Dysthymic Disorder, Disorders of Excessive Somnolence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
armodafinilDrug
200 mg/day
placeboDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | armodafinil 200 mg/day Receives: Drug: armodafinil |
| 2 | Placebo comparator | Placebo Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline on Maintenance of Wakefulness Test (MWT) to Endpoint (12 Weeks or Last Observation After Baseline)
MWT measures ability of subject to remain awake. Subjects instructed to try and remain awake during series of 4 30-minute periods (0900, 1100, 1300, and 1500) reclining in dark room. Each period was terminated immediately after sleep onset or at end of 30 minutes if no sleep occurred. If subject fell asleep, they were awakened and not allowed to sleep for remainder of that 30 minute period. Change from Baseline to Endpoint (12 weeks or last observation after baseline) in mean sleep latency averaged from the 4 intervals was measured. Poorest outcome was 0 minutes the best was 30 minutes.
Measured: Baseline and 12 weeks (or last observation after baseline)
Clinical Global Impression of Change (CGI-C) at Endpoint (12-weeks or Last Observation After Baseline)
The CGI-C is a clinician's rating of disease severity compared with baseline as assessed by Clinical Global Impression of Severity (CGI-S). CGI-C rates improvement by 7 categories: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse. CGI-S measured 7 categories of illness as well: normal, borderline ill, mildly ill, moderately ill, markedly ill, severely ill, among most extremely ill. Proportion of responders who had at least "minimally improved" in CGI-C ratings (as related to sleepiness) were assessed.
Measured: 12 weeks (or last observation after baseline)
Secondary outcomes (58)
Change From Baseline on the Epworth Sleepiness Scale (ESS) at Endpoint (12 Weeks or Last Measurement After Baseline)
For this key secondary outcome the ESS score is based on responses to questions (self administered) that assessed the propensity of the subject to fall asleep in 8 everyday situations (sitting and reading, talking to someone, being stopped in traffic, etc.) Scores for the ESS range from 0 to 24, with a higher score indicating greater daytime sleepiness. The change in ESS total score from baseline to Endpoint (12 weeks or last observation after baseline) are summarized.
Measured: Baseline and 12 weeks (or last observation after baseline)
Change From Baseline on Maintenance of Wakefulness Test (MWT) at 4 Weeks
MWT measures ability of subject to remain awake. Subjects instructed to try and remain awake during series of four 30-minute periods (0900, 1100, 1300, and 1500) reclining in dark room. Each period was terminated immediately after sleep onset or at end of 30 minutes if no sleep occured. If subject fell asleep, they were awakened and not allowed to sleep for remainder of that 30 minute period. Change from Baseline to 4 weeks in mean sleep latency (measured in minutes)averaged from each of the four testing intervals was measured. The poorest outcome was 0 minutes the best was 30 minutes.
Measured: baseline and 4 weeks
Change From Baseline on Maintenance of Wakefulness Test (MWT) at 8 Weeks
MWT measures ability of subject to remain awake. Subjects instructed to try and remain awake during series of four 30-minute periods (0900, 1100, 1300, and 1500) reclining in dark room. Each period was terminated immediately after sleep onset or at end of 30 minutes if no sleep occured. If subject fell asleep, they were awakened and not allowed to sleep for remainder of that 30 minute period. Change from Baseline to 8 weeks in mean sleep latency (measured in minutes)averaged from each of the four testing intervals was measured. The poorest outcome was 0 minutes the best was 30 minutes.
Measured: Baseline and 8 weeks following start of study drug administration
Change From Baseline on Maintenance of Wakefulness Test (MWT) at 12 Weeks
MWT measures ability of subject to remain awake. Subjects instructed to try and remain awake during series of four 30-minute periods (0900, 1100, 1300, and 1500) reclining in dark room. Each period was terminated immediately after sleep onset or at end of 30 minutes if no sleep occured. If subject fell asleep, they were awakened and not allowed to sleep for remainder of that 30 minute period. Change from Baseline to 12 weeks in mean sleep latency (measured in minutes)averaged from each of the four testing intervals was measured. The poorest outcome was 0 minutes the best was 30 minutes.
Measured: baseline and 12 weeks (or last observation after baseline)
Clinical Global Impression of Change (CGI-C) at 4 Weeks
The CGI-C is a clinician's rating of disease severity compared with baseline as assessed by Clinical Global Impression of Severity (CGI-S). CGI-C rates 7 responses: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse. CGI-S measured 7 categories as well: normal, borderline ill, mildly ill, moderately ill, markedly ill, severely ill, among most extremely ill. Proportion of responders who had at least "minimally improved" in CGI-C ratings (as related to sleepiness) at 4 weeks were assessed.
Measured: 4 weeks after beginning study drug treatment
Clinical Global Impression of Change (CGI-C) at 8 Weeks
The CGI-C is a clinician's rating of disease severity compared with baseline as assessed by Clinical Global Impression of Severity (CGI-S). CGI-C rates 7 responses: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse. CGI-S measured 7 categories as well: normal, borderline ill, mildly ill, moderately ill, markedly ill, severely ill, among most extremely ill. Proportion of responders who had at least "minimally improved" in CGI-C ratings (as related to sleepiness) at 8 weeks were assessed.
Measured: 8 weeks after beginning study drug treatment
Clinical Global Impression of Change (CGI-C) at 12 Weeks
The CGI-C is a clinician's rating of disease severity compared with baseline as assessed by Clinical Global Impression of Severity (CGI-S). CGI-C rates 7 responses: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse. CGI-S measured 7 categories as well: normal, borderline ill, mildly ill, moderately ill, markedly ill, severely ill, among most extremely ill. Proportion of responders who had at least minimal improvement in CGI-C ratings (as related to sleepiness) were assessed.
Measured: 12 weeks after beginning treatment
Clinical Global Impression of Change (CGI C) at 4 Weeks - Full Scale
The CGI-C is a clinician's rating of disease severity compared with baseline as assessed by Clinical Global Impression of Severity (CGI-S). CGI-C rates 7 responses: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse. CGI-S measured 7 categories as well: normal, borderline ill, mildly ill, moderately ill, markedly ill, severely ill, among most extremely ill. The results for the number of participants who responded to each item on the full scale at 4 weeks are presented.
Measured: 4 weeks after start of treatment
Clinical Global Impression of Change (CGI-C) at 8 Weeks - Full Scale
The CGI-C is a clinician's rating of disease severity compared with baseline as assessed by Clinical Global Impression of Severity (CGI-S). CGI-C rates 7 responses: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse. CGI-S measured 7 categories as well: normal, borderline ill, mildly ill, moderately ill, markedly ill, severely ill, among most extremely ill. The results for the number of participants who responded to each item on the full scale at 8 weeks are presented.
Measured: 8 weeks after start of study drug treatment
Clinical Global Impression of Change (CGI-C) at 12 Weeks - Full Scale
The CGI-C is a clinician's rating of disease severity compared with baseline as assessed by Clinical Global Impression of Severity (CGI-S). CGI-C rates 7 responses: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse. CGI-S measured 7 categories as well: normal, borderline ill, mildly ill, moderately ill, markedly ill, severely ill, among most extremely ill. The results for the number of participants who responded to each item on the full scale at 12 weeks are presented.
Measured: 12 weeks after starting study drug treatment
Change From Baseline on Epworth Sleepiness Scale (ESS) at 2 Weeks
ESS score is based on responses to questions (self administered) that assessed the propensity of the subject to fall asleep in 8 everyday situations (sitting and reading, talking to someone, being stopped in traffic, etc.) Scores for the ESS range from 0 to 24, with a higher score indicating greater daytime sleepiness. The change in ESS total score from baseline to two weeks are summarized.
Measured: Baseline and 2 weeks following start of study drug administration
Change From Baseline on Epworth Sleepiness Scale (ESS) at 4 Weeks
ESS score is based on responses to questions (self administered) that assessed the propensity of the subject to fall asleep in 8 everyday situations (sitting and reading, talking to someone, being stopped in traffic, etc.) Scores for the ESS range from 0 to 24, with a higher score indicating greater daytime sleepiness. The change in ESS total score from baseline to 4 weeks are summarized.
Measured: Baseline and 4 weeks after start of study drug administration
Change From Baseline on Epworth Sleepiness Scale (ESS) at 8 Weeks
ESS score is based on responses to questions (self administered) that assessed the propensity of the subject to fall asleep in 8 everyday situations (sitting and reading, talking to someone, being stopped in traffic, etc.) Scores for the ESS range from 0 to 24, with a higher score indicating greater daytime sleepiness. The change in ESS total score from baseline to 8 weeks are summarized.
Measured: Baseline and 8 weeks after start of study drug administration
Change From Baseline on Epworth Sleepiness Scale (ESS) at 12 Weeks
ESS score is based on responses to questions (self administered) that assessed the propensity of the subject to fall asleep in 8 everyday situations (sitting and reading, talking to someone, being stopped in traffic, etc.) Scores for the ESS range from 0 to 24, with a higher score indicating greater daytime sleepiness. The change in ESS total score from baseline to 12 weeks are summarized.
Measured: 12 weeks (or last observation after baseline)
Number of Responders According to the Epworth Sleepiness Scale (ESS) Total Score at 2 Weeks
ESS score is based on responses to questions (self administered) that assessed the propensity of the subject to fall asleep in 8 everyday situations (sitting and reading, talking to someone, being stopped in traffic, etc.) Scores for the ESS range from 0 to 24, with a higher score indicating greater daytime sleepiness. The number of responders who had a total ESS score < 10 and the number of non-responders with a total score >= 10 at 2 weeks are presented.
Measured: 2 weeks
Number of Responders According to the Epworth Sleepiness Scale (ESS) Total Score at 4 Weeks
ESS score is based on responses to questions (self administered) that assessed the propensity of the subject to fall asleep in 8 everyday situations (sitting and reading, talking to someone, being stopped in traffic, etc.) Scores for the ESS range from 0 to 24, with a higher score indicating greater daytime sleepiness. The number of responders who had a total ESS score < 10 and the number of non-responders with a total score >= 10 at 4 weeks are presented.
Measured: 4 weeks
Number of Responders According to the Epworth Sleepiness Scale (ESS) Total Score at 8 Weeks
ESS score is based on responses to questions (self administered) that assessed the propensity of the subject to fall asleep in 8 everyday situations (sitting and reading, talking to someone, being stopped in traffic, etc.) Scores for the ESS range from 0 to 24, with a higher score indicating greater daytime sleepiness. The number of responders who had a total ESS score < 10 and the number of non-responders with a total score >= 10 at 8 weeks are presented.
Measured: 8 weeks
Number of Responders According to the Epworth Sleepiness Scale (ESS) Total Score at 12 Weeks
ESS score is based on responses to questions (self administered) that assessed the propensity of the subject to fall asleep in 8 everyday situations (sitting and reading, talking to someone, being stopped in traffic, etc.) Scores for the ESS range from 0 to 24, with a higher score indicating greater daytime sleepiness. The number of responders who had a total ESS score < 10 and the number of non-responders with a total score >= 10 at 12 weeks are presented.
Measured: 12 weeks
Change From Baseline to Endpoint (Week 12 or Last Observation After Baseline) in the Brief Fatigue Inventory (BFI) Total Score
The Brief Fatigue Inventory (BFI) is a subjective-completed tool for the assessment of the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The total score is calculated by taking the sum of all 9 rating scales for a minimum score of 0 and a maximum score of 90. This assessment examines the difference in total BFI score from Baseline to 12 weeks or last observation after baseline.
Measured: Baseline and 12 weeks following start of study drug administration or last recorded observation
Change From Baseline on Brief Fatigue Inventory (BFI) Total Score at 2 Weeks
The Brief Fatigue Inventory (BFI) is a subjective-completed tool for the assessment of the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The total score is calculated by taking the sum of all 9 rating scales for a minimum score of 0 and a maximum score of 90. This assessment examines the difference in total BFI score from Baseline to 2 weeks.
Measured: Baseline and 2 weeks after start of study drug administration
Change From Baseline on Brief Fatigue Inventory (BFI) Total Score at 4 Weeks
The Brief Fatigue Inventory (BFI) is a subjective-completed tool for the assessment of the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The total score is calculated by taking the sum of all 9 rating scales for a minimum score of 0 and a maximum score of 90. This assessment examines the difference in total BFI score from Baseline to 4 weeks.
Measured: Baseline and 4 weeks after start of study drug administration
Change From Baseline on Brief Fatigue Inventory (BFI) Total Score at 8 Weeks
The Brief Fatigue Inventory (BFI) is a subjective-completed tool for the assessment of the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The total score is calculated by taking the sum of all 9 rating scales for a minimum score of 0 and a maximum score of 90. This assessment examines the difference in total BFI score from Baseline to 8 weeks.
Measured: Baseline and 8 weeks after start of study drug administration
Change From Baseline on Brief Fatigue Inventory (BFI) Total Score at 12 Weeks
The Brief Fatigue Inventory (BFI) is a subjective-completed tool for the assessment of the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The total score is calculated by taking the sum of all 9 rating scales for a minimum score of 0 and a maximum score of 90. This assessment examines the difference in total BFI score from Baseline to 12 weeks.
Measured: Baseline and 12 weeks after start of study drug administration
Change From Baseline on the Brief Fatigue Inventory (BFI) Worst Daily Fatigue Score at Endpoint (12 Weeks or Last Observation After Baseline)
The Brief Fatigue Inventory (BFI) is a subjective-completed tool for the assessment of the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with >= 7 indicative of severe fatigue. The worst daily fatigue score reports the outcome of a single item on the BFI that rates the worst fatigue experienced over the day on a scale from 0 to 10 with 0 being no fatigue and 10 being most severe. This measure compares the change in score from baseline to Week 12 (or last observation after baseline).
Measured: Baseline and 12 weeks or last observation after baseline
Change From Baseline on Brief Fatigue Inventory (BFI) Worse Daily Fatigue Score at 2 Weeks
The Brief Fatigue Inventory (BFI) is a subjective-completed tool for the assessment of the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The worst daily fatigue score reports the outcome of a single item on the BFI that rates the worst fatigue experienced over the day on a scale from 0 to 10 with 0 being no fatigue and 10 being most severe. This measure compares the change in score from baseline to Week 2.
Measured: Baseline and 2 weeks after start of study drug administration
Change From Baseline on Brief Fatigue Inventory (BFI) Worse Daily Fatigue Score at 4 Weeks
The Brief Fatigue Inventory (BFI) is a subjective-completed tool for the assessment of the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The worst daily fatigue score reports the outcome of a single item on the BFI that rates the worst fatigue experienced over the day on a scale from 0 to 10 with 0 being no fatigue and 10 being most severe. This measure compares the change in score from baseline to Week 4.
Measured: Baseline and 4 weeks after start of study drug administration
Change From Baseline on Brief Fatigue Inventory (BFI) Worse Daily Fatigue Score at 8 Weeks
The Brief Fatigue Inventory (BFI) is a subjective-completed tool for the assessment of the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The worst daily fatigue score reports the outcome of a single item on the BFI that rates the worst fatigue experienced over the day on a scale from 0 to 10 with 0 being no fatigue and 10 being most severe. This measure compares the change in score from baseline to Week 8.
Measured: Baseline and 8 weeks after start of study drug administration
Change From Baseline on Brief Fatigue Inventory (BFI) Worse Daily Fatigue Score at 12 Weeks
The Brief Fatigue Inventory (BFI) is a subjective-completed tool for the assessment of the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The worst daily fatigue score reports the outcome of a single item on the BFI that rates the worst fatigue experienced over the day on a scale from 0 to 10 with 0 being no fatigue and 10 being most severe. This measure compares the change in score from baseline to Week 12.
Measured: 12 weeks
Number of Responders According to Brief Fatigue Inventory (BFI) Worst Fatigue Score at Endpoint (12 Weeks or Last Observation After Baseline)
The Brief Fatigue Inventory (BFI) assesses the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The worst daily fatigue score reports the outcome of a single item on the BFI that rates the worst fatigue experienced over the day on a scale from 0 to 10 with 0 being no fatigue and 10 being most severe. Subjects were considered responders if the final Worst Fatigue Score was < 7 at Week 12 or last observation after baseline.
Measured: 12 weeks after start of study drug administration (or last observation after baseline)
Number of Responders According to the Brief Fatigue Inventory (BFI) Worst Fatigue Score at 2 Weeks
The Brief Fatigue Inventory (BFI) assesses the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The worst daily fatigue score reports the outcome of a single item on the BFI that rates the worst fatigue experienced over the day on a scale from 0 to 10 with 0 being no fatigue and 10 being most severe. Subjects were considered responders if the final Worst Fatigue Score was < 7 at Week 2.
Measured: 2 weeks after start of study drug administration
Number of Responders According to the Brief Fatigue Inventory (BFI) Worst Fatigue Score at 4 Weeks
The Brief Fatigue Inventory (BFI) assesses the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The worst daily fatigue score reports the outcome of a single item on the BFI that rates the worst fatigue experienced over the day on a scale from 0 to 10 with 0 being no fatigue and 10 being most severe. Subjects were considered responders if the final Worst Fatigue Score was < 7 at Week 4.
Measured: 4 weeks after start of study drug administration
Number of Responders According to the Brief Fatigue Inventory (BFI) Worst Fatigue Score at 8 Weeks
The Brief Fatigue Inventory (BFI) assesses the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The worst daily fatigue score reports the outcome of a single item on the BFI that rates the worst fatigue experienced over the day on a scale from 0 to 10 with 0 being no fatigue and 10 being most severe. Subjects were considered responders if the final Worst Fatigue Score was < 7 at Week 8.
Measured: 8 weeks after start of study drug administration
Number of Responders According to the Brief Fatigue Inventory (BFI) Worst Fatigue Score at 12 Weeks
The Brief Fatigue Inventory (BFI) assesses the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The worst daily fatigue score reports the outcome of a single item on the BFI that rates the worst fatigue experienced over the day on a scale from 0 to 10 with 0 being no fatigue and 10 being most severe. Subjects were considered responders if the final Worst Fatigue Score was < 7 at Week 12.
Measured: 12 weeks after start of study drug administration
Change From Baseline on Brief Fatigue Inventory (BFI) Interference Score at Endpoint (12 Weeks or Last Observation After Baseline)
The Brief Fatigue Inventory (BFI) assesses the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The Interference Score consists of 6 questions that ask subjects to rate on a 0 to 10 scale how during the past 24 hours fatigue has interfered with their general activity, mood, walking ability, normal work, relations with other people, and enjoyment of life. The scores are averaged (0-10) for the Interference Score.
Measured: Baseline and at endpoint (12 weeks or last observation after baseline)
Change From Baseline on Brief Fatigue Inventory (BFI) Interference Score at 2 Weeks
The Brief Fatigue Inventory (BFI) assesses the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The Interference Score consists of 6 questions that ask subjects to rate on a 0 to 10 scale how during the past 24 hours fatigue has interfered with their general activity, mood, walking ability, normal work, relations with other people, and enjoyment of life. The scores are averaged (0-10) for the Interference Score.
Measured: Baseline and 2 weeks after start of study drug administration
Change From Baseline on Brief Fatigue Inventory (BFI) Interference Score at 4 Weeks
The Brief Fatigue Inventory (BFI) assesses the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The Interference Score consists of 6 questions that ask subjects to rate on a 0 to 10 scale how during the past 24 hours fatigue has interfered with their general activity, mood, walking ability, normal work, relations with other people, and enjoyment of life. The scores are averaged (0-10) for the Interference Score.
Measured: Baseline and 4 weeks after start of study drug administration
Change From Baseline on Brief Fatigue Inventory (BFI) Interference Score at 8 Weeks
The Brief Fatigue Inventory (BFI) assesses the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The Interference Score consists of 6 questions that ask subjects to rate on a 0 to 10 scale how during the past 24 hours fatigue has interfered with their general activity, mood, walking ability, normal work, relations with other people, and enjoyment of life. The scores are averaged (0-10) for the Interference Score.
Measured: Baseline and 8 weeks after start of study drug administration
Change From Baseline on Brief Fatigue Inventory (BFI) Interference Score at 12 Weeks (or Last Observation After Baseline)
The Brief Fatigue Inventory (BFI) assesses the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The Interference Score consists of 6 questions that ask subjects to rate on a 0 to 10 scale how during the past 24 hours fatigue has interfered with their general activity, mood, walking ability, normal work, relations with other people, and enjoyment of life. The scores are averaged (0-10) for the Interference Score.
Measured: Baseline and 12 weeks after start of study drug administration
Change From Baseline on Functional Outcomes of Sleep Questionnaire (FOSQ) Total Score at Endpoint (12 Weeks or Last Observation After Baseline)
The FOSQ is a self-administered questionnaire that assess the impact of excessive sleepiness on functional outcomes relevant to daily behaviors. The questionnaire contains 30 questions each rated from 1 to 4 (1 indicating extreme difficulty 4 indicating no difficulty, or 0 indicating not applicable). A total score (minimum of 2 maximum of 120) was calculated from the responses. The change in total score from baseline to Endpoint (12 weeks or last observation after baseline) is presented here.
Measured: Baseline and endpoint (12 weeks after start of study drug or last observation after baseline)
Change From Baseline on Functional Outcomes of Sleep Questionnaire (FOSQ) Total Score at 2 Weeks
The FOSQ is a self-administered questionnaire that assess the impact of excessive sleepiness on functional outcomes relevant to daily behaviors. The questionnaire contains 30 questions each rated from 1 to 4 (1 indicating extreme difficulty 4 indicating no difficulty, or 0 indicating not applicable). A total score (minimum = 2 maximum = 120) was calculated from the responses. The change in total score from baseline to 2 weeks is presented here.
Measured: baseline and 2 weeks following start of study drug administration
Change From Baseline on Functional Outcomes of Sleep Questionnaire (FOSQ) Total Score at 4 Weeks
The FOSQ is a self-administered questionnaire that assess the impact of excessive sleepiness on functional outcomes relevant to daily behaviors. The questionnaire contains 30 questions each rated from 1 to 4 (1 indicating extreme difficulty 4 indicating no difficulty, or 0 indicating not applicable). A total score (minimum = 2 maximum = 120) was calculated from the responses. The change in total score from baseline to 4 weeks is presented here.
Measured: baseline and 4 weeks following start of study drug administration
Change From Baseline on Functional Outcomes of Sleep Questionnaire (FOSQ) Total Score at 8 Weeks
The FOSQ is a self-administered questionnaire that assess the impact of excessive sleepiness on functional outcomes relevant to daily behaviors. The questionnaire contains 30 questions each rated from 1 to 4 (1 indicating extreme difficulty 4 indicating no difficulty, or 0 indicating not applicable). A total score (minimum = 2 maximum = 120) was calculated from the responses. The change in total score from baseline to 8 weeks is presented here.
Measured: baseline and 8 weeks following start of study drug administration
Change From Baseline on Functional Outcomes of Sleep Questionnaire (FOSQ) Total Score at 12 Weeks
The FOSQ is a self-administered questionnaire that assess the impact of excessive sleepiness on functional outcomes relevant to daily behaviors. The questionnaire contains 30 questions each rated from 1 to 4 (1 indicating extreme difficulty 4 indicating no difficulty, or 0 indicating not applicable). A total score (minimum = 2 maximum = 120) was calculated from the responses. The change in total score from baseline to 12 weeks is presented here.
Measured: baseline and 12 weeks following the start of study drug administration
Number of Responders According to the Functional Outcomes of Sleep Questionnaire (FOSQ) Total Score at Endpoint (Week 12 or Last Observation After Baseline)
The FOSQ is a self-administered questionnaire that assess the impact of excessive sleepiness on functional outcomes relevant to daily behaviors. The questionnaire contains 30 questions each rated from 1 to 4 (1 indicating extreme difficulty 4 indicating no difficulty, or 0 indicating not applicable). A total score (minimum = 2 maximum = 120) was calculated from the responses. A responder analysis defining responders as patients with a total score > 17.9 at Endpoint (12 weeks or last observation after baseline) is presented.
Measured: Endpoint (week 12 or last observation after baseline)
Number of Responders According to the Functional Outcomes of Sleep Questionnaire (FOSQ) Total Score at 2 Weeks
The FOSQ is a self-administered questionnaire that assess the impact of excessive sleepiness on functional outcomes relevant to daily behaviors. The questionnaire contains 30 questions each rated from 1 to 4 (1 indicating extreme difficulty 4 indicating no difficulty, or 0 indicating not applicable). A total score (minimum=2 maximum=120) was calculated from the responses. A responder analysis defining responders as patients with a total score > 17.9 at 2 weeks is presented here.
Measured: 2 weeks following start of study drug administration
Number of Responders According to the Functional Outcomes of Sleep Questionnaire (FOSQ) at Week 4
The FOSQ is a self-administered questionnaire that assess the impact of excessive sleepiness on functional outcomes relevant to daily behaviors. The questionnaire contains 30 questions each rated from 1 to 4 (1 indicating extreme difficulty 4 indicating no difficulty, or 0 indicating not applicable). A total score (minimum=2 maximum = 120) was calculated from the responses. A responder analysis defining responders as patients with a total score > 17.9 at 4 weeks is presented here.
Measured: 4 weeks following start of study drug administration
Number of Responders According to the Functional Outcomes of Sleep Questionnaire (FOSQ) at Week 8
The FOSQ is a self-administered questionnaire that assess the impact of excessive sleepiness on functional outcomes relevant to daily behaviors. The questionnaire contains 30 questions each rated from 1 to 4 (1 indicating extreme difficulty 4 indicating no difficulty, or 0 indicating not applicable). A total score was calculated from the responses (minimum = 2 maximum = 120). A responder analysis defining responders as patients with a total score > 17.9 at 8 weeks is presented here.
Measured: 8 weeks following start of study drug administration
Number of Responders According to the Functional Outcomes of Sleep Questionnaire (FOSQ) at Week 12
The FOSQ is a self-administered questionnaire that assess the impact of excessive sleepiness on functional outcomes relevant to daily behaviors. The questionnaire contains 30 questions each rated from 1 to 4 (1 indicating extreme difficulty 4 indicating no difficulty, or 0 indicating not applicable). A total score (minimum = 2 maximum = 120) was calculated from the responses. A responder analysis defining responders as patients with a total score > 17.9 at 12 weeks is presented here.
Measured: 12 weeks following the start of study drug administration
Change From Baseline on Medical Outcomes Study 6 Item Cognitive Functioning (MOS-CF6) Scale at Endpoint (12 Weeks or Last Observation After Baseline)
The MOS-CF6 assesses self-reported cognitive function. Items were selected to cover 6 relevant aspects of cognitive functioning:confusion, concentration/thinking, attention, memory, reasoning, problem-solving, and processing speed. Responses range from "none of the time" to "all of the time". The MOS-CF6 is scored by summing responses across the 6 items and converting the total to a 0 - 100 point scale, with the higher score indicating better cognitive functioning. Data is presented showing the change in score from baseline to Endpoint (12 weeks or last observation after baseline).
Measured: Baseline and Endpoint (12 weeks or last observation after baseline)
Change From Baseline on Medical Outcomes Study 6 Item Cognitive Functioning (MOS-CF6) Scale at 2 Weeks
The MOS-CF6 assesses self-reported cognitive function. Items were selected to cover 6 relevant aspects of cognitive functioning as follows: confusion, concentration/thinking, attention, memory, reasoning, problem-solving, and processing speed. The MOS-CF6 responses includes 6 choices, ranging from "none of the time" to "all of the time". The MOS-CF6 is scored by summing responses across the 6 items and converting the total to a 0 - 100 point scale, with the higher score indicating better cognitive functioning. Data is presented showing the change in score from baseline to 2 weeks.
Measured: baseline and 2 weeks
Change From Baseline on Medical Outcomes Study 6 Item Cognitive Functioning (MOS-CF6) Scale at 4 Weeks
The MOS-CF6 assesses self-reported cognitive function. Items were selected to cover 6 relevant aspects of cognitive functioning as follows: confusion, concentration/thinking, attention, memory, reasoning, problem-solving, and processing speed. The MOS-CF6 responses includes 6 choices, ranging from "none of the time" to "all of the time". The MOS-CF6 is scored by summing responses across the 6 items and converting the total to a 0 - 100 point scale, with the higher score indicating better cognitive functioning. Data is presented showing the change in score from baseline to 4 weeks.
Measured: baseline and 4 weeks following start of study drug administration
Change From Baseline on Medical Outcomes Study 6 Item Cognitive Functioning (MOS-CF6) Scale at 8 Weeks
The MOS-CF6 assesses self-reported cognitive function. Items were selected to cover 6 relevant aspects of cognitive functioning as follows: confusion, concentration/thinking, attention, memory, reasoning, problem-solving, and processing speed. The MOS-CF6 responses includes 6 choices, ranging from "none of the time" to "all of the time". The MOS-CF6 is scored by summing responses across the 6 items and converting the total to a 0 - 100 point scale, with the higher score indicating better cognitive functioning. Data is presented showing the change in score from baseline to 8 weeks.
Measured: baseline and 8 weeks following start of study drug administration
Change From Baseline on Medical Outcomes Study 6 Item Cognitive Functioning (MOS-CF6) Scale at 12 Weeks
The MOS-CF6 assesses self-reported cognitive function. Items were selected to cover 6 relevant aspects of cognitive functioning as follows: confusion, concentration/thinking, attention, memory, reasoning, problem-solving, and processing speed. The MOS-CF6 responses includes 6 choices, ranging from "none of the time" to "all of the time". The MOS-CF6 is scored by summing responses across the 6 items and converting the total to a 0 - 100 point scale, with the higher score indicating better cognitive functioning. Data is presented showing the change in score from baseline to 12 weeks.
Measured: baseline and 12 weeks following start of study drug administration
Change From Baseline in the Excessive Sleepiness (ES) Symptom Rating Form - Sleepiness Scores at Endpoint (12 Weeks or Last Observation After Baseline)
The Excessive Sleepiness Symptom Rating Form was used to assess symptoms of excessive sleepiness. Patients rate 7 symptoms(tiredness, fatigue, sleepiness, lack of energy, trouble paying attention, forgetfulness, trouble staying organized) on an 11-point Likert scale (0 = no problem at all to 10 = as bad as you can imagine). ES Symptom Rating Form was designed to follow the response to treatment measuring severity of each of these 7 symptoms using the same 11-point scale. Change from Baseline to Endpoint (12 weeks or last baseline observation) is presented only for the symptom of "Sleepiness".
Measured: Baseline and Endpoint (12 weeks or last observation after baseline)
Change From Baseline in the Excessive Sleepiness (ES) Symptom Rating Form - Sleepiness Scores at 2 Weeks
Cephalon created the Excessive Sleepiness Symptom Rating Form to assess symptoms of excessive sleepiness. Patients rate 7 symptoms(Tiredness, Fatigue, Sleepiness, Lack of energy, Trouble paying attention, Forgetfulness, Trouble staying organized) each on an 11-point Likert scale(0="no problem at all" 10="as bad as you can imagine"). ES Symptom Rating Form was designed to follow the response to treatment (measuring severity) of each of these 7 symptoms using the same 11-point scale. Change from Baseline to 2 Weeks is presented only for the symptom of "Sleepiness".
Measured: Baseline and 2 weeks
Change From Baseline in the Excessive Sleepiness (ES) Symptom Rating Form - Sleepiness Scores at 4 Weeks
Cephalon created the Excessive Sleepiness Symptom Rating Form to assess symptoms of excessive sleepiness. Patients rate 7 symptoms(Tiredness, Fatigue, Sleepiness, Lack of energy, Trouble paying attention, Forgetfulness, Trouble staying organized) each on an 11-point Likert scale(0="no problem at all" 10="as bad as you can imagine"). ES Symptom Rating Form was designed to follow the response to treatment (measuring severity) of each of these 7 symptoms using the same 11-point scale. Change from Baseline to 4 Weeks is presented only for the symptom of "Sleepiness".
Measured: Baseline and 4 weeks following start of study drug administration
Change From Baseline in the Excessive Sleepiness (ES) Symptom Rating Form - Sleepiness Scores at 8 Weeks
Cephalon created the Excessive Sleepiness Symptom Rating Form to assess symptoms of excessive sleepiness. Patients rate 7 symptoms(Tiredness, Fatigue, Sleepiness, Lack of energy, Trouble paying attention, Forgetfulness, Trouble staying organized) each on an 11-point Likert scale(0="no problem at all" 10="as bad as you can imagine"). ES Symptom Rating Form was designed to follow the response to treatment (measuring severity) of each of these 7 symptoms using the same 11-point scale. Change from Baseline to 8 Weeks is presented only for the symptom of "Sleepiness".
Measured: baseline and 8 weeks following start of study drug administration
Change From Baseline in the Excessive Sleepiness (ES) Symptom Rating Form - Sleepiness Scores at 12 Weeks
Cephalon created the Excessive Sleepiness Symptom Rating Form to assess symptoms of excessive sleepiness. Patients rate 7 symptoms(Tiredness, Fatigue, Sleepiness, Lack of energy, Trouble paying attention, Forgetfulness, Trouble staying organized) each on an 11-point Likert scale(0="no problem at all" 10="as bad as you can imagine"). ES Symptom Rating Form was designed to follow the response to treatment (measuring severity) of each of these 7 symptoms using the same 11-point scale. Change from Baseline to 12 Weeks is presented only for the symptom of "Sleepiness".
Measured: Baseline and 12 weeks following start of study drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2007 (estimated)
- Study startOct 2007
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 249 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cephalon
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00518986
- Sponsor's protocol ID
- C10953/4024/ES/US
- Status last verified
- Jul 2013
- First submitted
- 17 Aug 2007
- Last updated
- 19 Jul 2013
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Krystal AD, Harsh JR, Yang R, Rippon GA, Lankford DA. A double-blind, placebo-controlled study of armodafinil for excessive sleepiness in patients with treated obstructive sleep apnea and comorbid depression. J Clin Psychiatry. 2010 Jan;71(1):32-40. doi: 10.4088/JCP.09m05536gry. Epub 2009 Dec 29.
PubMed 20051221
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-Blind, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of Armodafinil for Adults With Excessive Sleepiness Associated With Obstructive Sleep Apnea/Hypopnea Syndrome With Major Depressive Disorder or Dysthymic Disorder
- ClinicalTrials.gov ID
- NCT00518986
- Acronym / sponsor ID
- C10953/4024/ES/US
- Keywords
- Obstructive Sleep Apnea/Hypopnea Syndrome, Excessive Sleepiness
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 249 participants (actual)
- Lead sponsor
- CephalonIndustry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 21 Aug 2007 (estimated)
- Results
- Posted 29 Mar 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of the study is to evaluate whether armodafinil at a target dosage of 200 mg/day is more effective than placebo treatment in improving excessive sleepiness in patients with obstructive sleep apnea/hypopnea syndrome (OSAHS) who have comorbid major depressive disorder or dysthymic disorder.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: armodafinilarmodafinil 200 mg/day |
| 2 | Placebo comparator | Drug: placeboPlacebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Current diagnosis of obstructive sleep apnea/hypopnea syndrome (OSAHS)
- Complaint of residual excessive sleepiness despite nasal continuous positive airway pressure (nCPAP) therapy being effective
- Current or prior diagnosis of major depressive disorder or dysthymic disorder
- Clinically stable with regard to depressed mood and has shown a treatment response to selective serotonin reuptake inhibitor (SSRI) therapy or serotonin and norepinephrine reuptake inhibitor (SNRI) therapy
- Patient has been on a stable monotherapy dose of an allowed SSRI or SNRI for at least 8 weeks at the time of screening
Key exclusion criteria (17 listed)
- Confirmed or suspected diagnosis of a currently active sleep disorder other than obstructive sleep apnea/hypopnea syndrome (OSAHS)
- Current episode of major depression that is considered to be treatment-resistant
- A primary diagnosis of: eating disorder, psychotic disorder, delirium, dementia, substance-related disorders, or moderate to severe hypochondriasis
- Patient has a history of bipolar disorder, psychotic depression, schizophrenia, schizoaffective disorder, any other psychotic disorder, or other clinically significant uncontrolled psychiatric condition.
- Patient has a history of homicidal ideation or significant aggression
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| armodafinil200 mg/day | Drug | 1 |
| placeboplacebo | Drug | 2 |
Primary outcome
Change From Baseline on Maintenance of Wakefulness Test (MWT) to Endpoint (12 Weeks or Last Observation After Baseline)
Time frame: Baseline and 12 weeks (or last observation after baseline)
MWT measures ability of subject to remain awake. Subjects instructed to try and remain awake during series of 4 30-minute periods (0900, 1100, 1300, and 1500) reclining in dark room. Each period was terminated immediately after sleep onset or at end of 30 minutes if no sleep occurred. If subject fell asleep, they were awakened and not allowed to sleep for remainder of that 30 minute period. Change from Baseline to Endpoint (12 weeks or last observation after baseline) in mean sleep latency averaged from the 4 intervals was measured. Poorest outcome was 0 minutes the best was 30 minutes.
Clinical Global Impression of Change (CGI-C) at Endpoint (12-weeks or Last Observation After Baseline)
Time frame: 12 weeks (or last observation after baseline)
The CGI-C is a clinician's rating of disease severity compared with baseline as assessed by Clinical Global Impression of Severity (CGI-S). CGI-C rates improvement by 7 categories: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse. CGI-S measured 7 categories of illness as well: normal, borderline ill, mildly ill, moderately ill, markedly ill, severely ill, among most extremely ill. Proportion of responders who had at least "minimally improved" in CGI-C ratings (as related to sleepiness) were assessed.
58 secondary outcomes
Change From Baseline on the Epworth Sleepiness Scale (ESS) at Endpoint (12 Weeks or Last Measurement After Baseline)
Time frame: Baseline and 12 weeks (or last observation after baseline)
Change From Baseline on Maintenance of Wakefulness Test (MWT) at 4 Weeks
Time frame: baseline and 4 weeks
Change From Baseline on Maintenance of Wakefulness Test (MWT) at 8 Weeks
Time frame: Baseline and 8 weeks following start of study drug administration
Change From Baseline on Maintenance of Wakefulness Test (MWT) at 12 Weeks
Time frame: baseline and 12 weeks (or last observation after baseline)
Clinical Global Impression of Change (CGI-C) at 4 Weeks
Time frame: 4 weeks after beginning study drug treatment
Clinical Global Impression of Change (CGI-C) at 8 Weeks
Time frame: 8 weeks after beginning study drug treatment
Clinical Global Impression of Change (CGI-C) at 12 Weeks
Time frame: 12 weeks after beginning treatment
Clinical Global Impression of Change (CGI C) at 4 Weeks - Full Scale
Time frame: 4 weeks after start of treatment
Clinical Global Impression of Change (CGI-C) at 8 Weeks - Full Scale
Time frame: 8 weeks after start of study drug treatment
Clinical Global Impression of Change (CGI-C) at 12 Weeks - Full Scale
Time frame: 12 weeks after starting study drug treatment
Change From Baseline on Epworth Sleepiness Scale (ESS) at 2 Weeks
Time frame: Baseline and 2 weeks following start of study drug administration
Change From Baseline on Epworth Sleepiness Scale (ESS) at 4 Weeks
Time frame: Baseline and 4 weeks after start of study drug administration
Change From Baseline on Epworth Sleepiness Scale (ESS) at 8 Weeks
Time frame: Baseline and 8 weeks after start of study drug administration
Change From Baseline on Epworth Sleepiness Scale (ESS) at 12 Weeks
Time frame: 12 weeks (or last observation after baseline)
Number of Responders According to the Epworth Sleepiness Scale (ESS) Total Score at 2 Weeks
Time frame: 2 weeks
Number of Responders According to the Epworth Sleepiness Scale (ESS) Total Score at 4 Weeks
Time frame: 4 weeks
Number of Responders According to the Epworth Sleepiness Scale (ESS) Total Score at 8 Weeks
Time frame: 8 weeks
Number of Responders According to the Epworth Sleepiness Scale (ESS) Total Score at 12 Weeks
Time frame: 12 weeks
Change From Baseline to Endpoint (Week 12 or Last Observation After Baseline) in the Brief Fatigue Inventory (BFI) Total Score
Time frame: Baseline and 12 weeks following start of study drug administration or last recorded observation
Change From Baseline on Brief Fatigue Inventory (BFI) Total Score at 2 Weeks
Time frame: Baseline and 2 weeks after start of study drug administration
Change From Baseline on Brief Fatigue Inventory (BFI) Total Score at 4 Weeks
Time frame: Baseline and 4 weeks after start of study drug administration
Change From Baseline on Brief Fatigue Inventory (BFI) Total Score at 8 Weeks
Time frame: Baseline and 8 weeks after start of study drug administration
Change From Baseline on Brief Fatigue Inventory (BFI) Total Score at 12 Weeks
Time frame: Baseline and 12 weeks after start of study drug administration
Change From Baseline on the Brief Fatigue Inventory (BFI) Worst Daily Fatigue Score at Endpoint (12 Weeks or Last Observation After Baseline)
Time frame: Baseline and 12 weeks or last observation after baseline
Change From Baseline on Brief Fatigue Inventory (BFI) Worse Daily Fatigue Score at 2 Weeks
Time frame: Baseline and 2 weeks after start of study drug administration
Change From Baseline on Brief Fatigue Inventory (BFI) Worse Daily Fatigue Score at 4 Weeks
Time frame: Baseline and 4 weeks after start of study drug administration
Change From Baseline on Brief Fatigue Inventory (BFI) Worse Daily Fatigue Score at 8 Weeks
Time frame: Baseline and 8 weeks after start of study drug administration
Change From Baseline on Brief Fatigue Inventory (BFI) Worse Daily Fatigue Score at 12 Weeks
Time frame: 12 weeks
Number of Responders According to Brief Fatigue Inventory (BFI) Worst Fatigue Score at Endpoint (12 Weeks or Last Observation After Baseline)
Time frame: 12 weeks after start of study drug administration (or last observation after baseline)
Number of Responders According to the Brief Fatigue Inventory (BFI) Worst Fatigue Score at 2 Weeks
Time frame: 2 weeks after start of study drug administration
Number of Responders According to the Brief Fatigue Inventory (BFI) Worst Fatigue Score at 4 Weeks
Time frame: 4 weeks after start of study drug administration
Number of Responders According to the Brief Fatigue Inventory (BFI) Worst Fatigue Score at 8 Weeks
Time frame: 8 weeks after start of study drug administration
Number of Responders According to the Brief Fatigue Inventory (BFI) Worst Fatigue Score at 12 Weeks
Time frame: 12 weeks after start of study drug administration
Change From Baseline on Brief Fatigue Inventory (BFI) Interference Score at Endpoint (12 Weeks or Last Observation After Baseline)
Time frame: Baseline and at endpoint (12 weeks or last observation after baseline)
Change From Baseline on Brief Fatigue Inventory (BFI) Interference Score at 2 Weeks
Time frame: Baseline and 2 weeks after start of study drug administration
Change From Baseline on Brief Fatigue Inventory (BFI) Interference Score at 4 Weeks
Time frame: Baseline and 4 weeks after start of study drug administration
Change From Baseline on Brief Fatigue Inventory (BFI) Interference Score at 8 Weeks
Time frame: Baseline and 8 weeks after start of study drug administration
Change From Baseline on Brief Fatigue Inventory (BFI) Interference Score at 12 Weeks (or Last Observation After Baseline)
Time frame: Baseline and 12 weeks after start of study drug administration
Change From Baseline on Functional Outcomes of Sleep Questionnaire (FOSQ) Total Score at Endpoint (12 Weeks or Last Observation After Baseline)
Time frame: Baseline and endpoint (12 weeks after start of study drug or last observation after baseline)
Change From Baseline on Functional Outcomes of Sleep Questionnaire (FOSQ) Total Score at 2 Weeks
Time frame: baseline and 2 weeks following start of study drug administration
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 20051221Krystal AD, Harsh JR, Yang R, Rippon GA, Lankford DA. A double-blind, placebo-controlled study of armodafinil for excessive sleepiness in patients with treated obstructive sleep apnea and comorbid depression. J Clin Psychiatry. 2010 Jan;71(1):32-40. doi: 10.4088/JCP.09m05536gry. Epub 2009 Dec 29.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
62 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing armodafinil in people with Sleep Disorders and Obstructive Sleep Apnea, run by Cephalon at 62 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 62 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Mar 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline on Maintenance of Wakefulness Test (MWT) to Endpoint (12 Weeks or Last Observation After Baseline) (time frame: Baseline and 12 weeks (or last observation after baseline)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00518986, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2013.