SchizophreniaNCT00546403
Modafinil Augmentation Therapy for Excessive Daytime Sleepiness and Negative Symptoms in Patients With Schizophrenia
A study testing Modafinil in people with Schizophrenia, run by Veterans Medical Research Foundation at 1 site in United States.
Trial summary
The purpose of this study is to test the effect of modafinil on the negative symptoms, such as blunted affect and social withdrawal, of schizophrenic patients and to determine modafinil's effect on excessive daytime sleepiness. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Modafinil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2003to Feb 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must be able to communicate and give voluntary informed consent
- Subjects must be of the male gender
- Between the ages of 18 to 65 years.
- A diagnosis of Schizophrenia or Schizoaffective disorder as determined by DSM-IV criteria.
- Not conservatorized
- A negative symptom score on the PANSS of >= 20 and an MMSE score of >24
Show all 22Show fewer
- No clinical evidence of a current unstable medical illness
- No current clinical evidence or past history of cerebral neurological impairment (including strokes, tumors or trauma leading to loss of consciousness)
- No history of drug or alcohol dependence in the past 2 years
- No evidence of drug or alcohol abuse in the past year, as determined by the DSM-IV criteria.
- No diagnosis of Narcolepsy as determined by DSM-IV criteria
- Must have an approved contact person for the duration of the study
- May be on a stable dose of SSRI for depressive symptoms
- No history of aggression
- No uncontrolled hypertension, as defined below (subjects cannot have any of the following):
- a new diagnosis of hypertension, or
- a change in antihypertensive medications in the past 30 days, or
- acute hypertension (systolic>160mmHg, diastolic>100mmHg)
- Maybe on a stable dose of a benzodiazepine
- The following medications will not be allowed during the study- methylphenidate, amphetamines, pemoline, zolpidem, MAO inhibitors, anticoagulant, TCA's, or barbiturates.
- Be on a stable does of an atypical neuroleptic
- May be on a stable does of an anticonvulsant for mood stabilization
Who cannot join
- Subjects cannot be female.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Healthcare System, Department of Psychiatry
San Diego, California, 92161
About this study
Official title: An Eight Week, Double-Blind, Placebo Controlled, Adjunctive Study of the Primary Effects of the Use of Flexible Doses of Modafinil 50mg to 200mg, on the Negative Symptoms, Cognition, and Excessive Daytime Sleepiness in Schizophrenic Patients
The purpose of this study is to test the effect of modafinil on the negative symptoms, such as blunted affect and social withdrawal, of schizophrenic patients and to determine modafinil's effect on excessive daytime sleepiness. A secondary purpose of the study is to examine the effect of modafinil on cognitive functioning of schizophrenic patients.
Read the detailed description
Twenty six male patients with schizophrenia (twelve with Excessive Daytime Sleepiness and twelve without) will be enrolled at the San Diego Veterans Affairs Medical Center. Modafinil has been shown to increase alertness in individuals who are pathologically sleepy (Study C1538a/301/NAIUS).
Subjects will be randomized in a 1:1 ratio, stratified by excessive daytime sleepiness (value of >=9 on the Epworth Sleepiness Scale). Subjects will receive either modafinil or placebo, supplied by the sponsor. The study drug will be taken by mouth once daily in the morning. The titration schedule will be as follows:
- The beginning does will be 50mg for 2 weeks
- The study medication will be increased to 100mg at the week 2 study visit
- The study medication will be increased to 200mg at the week 4 study visit and will continue for the remaining 4 weeks of the study. If subjects are unable to tolerate dosage increases, the dose will be decreased to the previous level.
- Conditions
- Schizophrenia
- Being tested
- Modafinil, Placebo
- Keywords
- Excessive Daytime Sleepiness
- Medical subject headings
- Schizophrenia, Disorders of Excessive Somnolence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ModafinilDrug
Also called Provigil
Adjunctive treatment with titrated dose of modafinil
PlaceboDrug
Adjunctive treatment with placebo
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Adjunctive treatment with placebo Receives: Drug: Placebo |
| Modafinil | Experimental | Treatment with titrated dose of study drug, modafinil. Receives: Drug: Modafinil |
What is being measured
The primary outcome is the main question the study is designed to answer.
PANSS, and Sleep/wake activity measured using the Actillume (Ambulatory Monitoring, Inc.)
Measured: baseline, one month, two months
Secondary outcomes (1)
Neuropsychological Assessments that target cognitive abilities.
Measured: baseline, one month, two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2007 (estimated)
- Study startFeb 2003
- Primary completionFeb 2008
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Veterans Medical Research Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Cephalon
- Investigators
- James B Lohr, MD, PhD, Principal investigator, Director, VA Center of Excellence for Stress and Mental Health (CESAMH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00546403
- Sponsor's protocol ID
- C1538a-633
- Status last verified
- Oct 2007
- First submitted
- 17 Oct 2007
- Last updated
- 24 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Eight Week, Double-Blind, Placebo Controlled, Adjunctive Study of the Primary Effects of the Use of Flexible Doses of Modafinil 50mg to 200mg, on the Negative Symptoms, Cognition, and Excessive Daytime Sleepiness in Schizophrenic Patients
- ClinicalTrials.gov ID
- NCT00546403
- Acronym / sponsor ID
- C1538a-633
- Conditions
- Schizophrenia
- Keywords
- Excessive Daytime Sleepiness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Veterans Medical Research FoundationUniversity, hospital or other
- Collaborators
- Cephalon
- Study start
- Feb 2003
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 19 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test the effect of modafinil on the negative symptoms, such as blunted affect and social withdrawal, of schizophrenic patients and to determine modafinil's effect on excessive daytime sleepiness. A secondary purpose of the study is to examine the effect of modafinil on cognitive functioning of schizophrenic patients.
Detailed description
Twenty six male patients with schizophrenia (twelve with Excessive Daytime Sleepiness and twelve without) will be enrolled at the San Diego Veterans Affairs Medical Center. Modafinil has been shown to increase alertness in individuals who are pathologically sleepy (Study C1538a/301/NAIUS).
Subjects will be randomized in a 1:1 ratio, stratified by excessive daytime sleepiness (value of >=9 on the Epworth Sleepiness Scale). Subjects will receive either modafinil or placebo, supplied by the sponsor. The study drug will be taken by mouth once daily in the morning. The titration schedule will be as follows:
- The beginning does will be 50mg for 2 weeks
- The study medication will be increased to 100mg at the week 2 study visit
- The study medication will be increased to 200mg at the week 4 study visit and will continue for the remaining 4 weeks of the study. If subjects are unable to tolerate dosage increases, the dose will be decreased to the previous level.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboAdjunctive treatment with placebo |
| Modafinil | Experimental | Drug: ModafinilTreatment with titrated dose of study drug, modafinil. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Subjects must be able to communicate and give voluntary informed consent
- Subjects must be of the male gender
- Between the ages of 18 to 65 years.
- A diagnosis of Schizophrenia or Schizoaffective disorder as determined by DSM-IV criteria.
- Not conservatorized
Key exclusion criteria (1 listed)
- Subjects cannot be female.
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 |
|---|---|---|
| ModafinilAlso: ProvigilAdjunctive treatment with titrated dose of modafinil | Drug | Modafinil |
| PlaceboAdjunctive treatment with placebo | Drug | Placebo |
Primary outcome
PANSS, and Sleep/wake activity measured using the Actillume (Ambulatory Monitoring, Inc.)
Time frame: baseline, one month, two months
1 secondary outcome
Neuropsychological Assessments that target cognitive abilities.
Time frame: baseline, one month, two months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2009.
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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.
James B Lohr, MD, PhD principal investigator
Director, VA Center of Excellence for Stress and Mental Health (CESAMH)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modafinil in people with Schizophrenia, run by Veterans Medical Research Foundation at 1 site 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 22 inclusion and 1 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 24 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
PANSS, and Sleep/wake activity measured using the Actillume (Ambulatory Monitoring, Inc.) (time frame: baseline, one month, two months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Feb 2009.