InsomniaPhase 4NCT01662297
Comparison of Quetiapine and Trazodone Treatment for Insomnia in Dually Diagnosed Veterans
A Phase 4 study testing Quetiapine and Trazodone in people with Insomnia and Mental Health Disorder, run by VA Connecticut Healthcare System at 1 site in United States.
Trial summary
This is a pilot comparative effectiveness study designed to determine whether trazodone is as effective as quetiapine for treatment of insomnia in veterans with a history of addiction and mental health issues. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Insomnia, Mental Health Disorder, Substance Use Disorder
- What is being tested?
- Quetiapine and Trazodone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to Oct 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Identified by their VA prescribing provider as taking quetiapine primarily as a sedative/hypnotic agent for some form of insomnia for at least 1 month
- Identified by their VA prescribing provider as having dual diagnosis; a lifetime history of substance use disorder and a mental disorder
- Willing to meet with a research assistant to answer several questions regarding their use of and experience with quetiapine.
- Appear not to be regularly on any medication which would be an exclusion for Part II (see Part II exclusion criteria).
- Willing to provide written informed consent.
- Provider reports that primary use of quetiapine is for insomnia for at least one month and not primary or augmentation treatment of mood, anxiety disorder, psychosis, or mood stabilization.
Show all 10Show fewer
- Have a self-identified and provider confirmed lifetime history of mental health and substance use disorder (dual diagnosis).
- Currently taking Quetiapine up to 300mg daily for the primary purpose of treating insomnia, and have been taking it for at least 1 month (30 days).
- Use of an acceptable method of birth control by female patients who have a possibility of becoming pregnant.
- The provider should review the patients from the identified charts, and fill out information about the patient and why they are on the drug, and provider should consent to us approaching the client and potentially switching them; the investigators will not approach and begin enrollment for part II on subjects if their provider feels it is not appropriate for them for any reason.
Who cannot join
- Physiologic substance dependence requiring detoxification in the past 30 days (substance abuse is not an exclusion).
- Concomitant administration of: other sedative hypnotics, benzodiazepines, prazosin, other atypical antipsychotics, stimulants, ketoconazole and other inhibitors of cytochrome P450 3A (e.g., itraconazole, fluconazole, erythromycin, and protease inhibitors), phenytoin or other strong inducers of cytochrome P450 enzymes.
- Intolerance or hypersensitivity to trazodone.
- Pregnant or lactating women or women planning to become pregnant.
- Hepatic or renal problems AST or ALT (>3 times upper limit of normal);
- Elevated bilirubin (>1.2), BUN (>24), creatinine (>1.7).
Show all 11Show fewer
- Unstable, serious medical condition or one requiring acute medical treatment, or anticipation of hospitalization for extended care.
- Dementia, epilepsy, insulin-dependent diabetes, anticoagulation with coumadin.
- Legal entanglements or pending legal charges with potential of incarceration.
- Recent (i.e., past 3 months) assault or suicide gesture currently needing acute intervention.
- Concurrent participation in another clinical trial with an investigational drug during the last 30 days.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Connecticut Healthcare System
West Haven, Connecticut, 06516
About this study
Official title: Comparison of Quetiapine and Trazodone Treatment for Insomnia in Dually Diagnosed Veterans: an Open (e.g. Unblinded) Randomized Stay-Switch Pilot Trial
This is a pilot comparative effectiveness study designed to determine whether trazodone is as effective as quetiapine for treatment of insomnia in veterans with a history of addiction and mental health issues. The study will have two concurrent phases (parts); first an acceptability determination phase, to determine whether and why (or why not) veterans already taking quetiapine are willing to try an alternative to quetiapine for sleep; and second, a randomized trial phase which will test whether staying on quetiapine has any advantage over switching to trazodone. The purpose of the first phase will be a) to document the proportions of patients and physicians who are willing to agree to such a switch, b) to characterize sociodemographic and clinical characteristics of potentially eligible subjects associated with a willingness to switch from quetiapine to trazodone and c) to record the reasons given why patients and their prescribers are (or are not) willing to accept a switch from quetiapine to trazodone. It will also function to provide some educational background to patients and a reminder to providers about the potential severe side-effects of quetiapine, and will thus facilitate clinical informed consent for the clinical trial phase of the study. Completion of the first part of the study will also serve as the screening component for part II. Part II includes, first, obtaining written informed consent from eligible subjects, and then randomly assigning them to continue quetiapine or to be switched to trazodone in open-label "real world" fashion for the duration of 4 weeks, followed by another four weeks of open, non-randomized follow- up. The purpose of the second part of the study is to determine if trazodone is an adequate substitute for quetiapine, primarily in terms of treating insomnia. The investigators hypothesize that trazodone will not be inferior to quetiapine in maintaining good quality of sleep measured by sleep scales (i.e., scores will not significantly worsen once switched). This study is open to Veterans in the VA system only. Eligible subjects must have a history of "dual diagnosis" (i.e., a history of addiction and mental illness).
Read the detailed description
Part I of the study involves identification through VA records of subjects eligible for the study based on their prescription of quetiapine. Potentially eligible subjects will be contacted by the research team. Subjects will answer a brief questionnaire about their experience with the medication quetiapine as used for insomnia. If subjects are interested in participated in part II, the clinical trial portion of the study, they will be further screened for eligibility.
Part II consists of a 4 week clinical trial in which subjects are randomized to stay on quetiapine or switch to trazodone, all of which will be open-label. Subjects will be evaluated for symptoms of sleep quality and excessive daytime sleepiness. subjects will also be assessed for changes in mood, and alcohol/drug use. After the initial 4 week treatment period, subjects on trazodone can choose to switch back to quetiapine or continue on trazodone. Subjects will also be evaluated after an additional 4 weeks (8weeks from start of the study) on outcome measures.
- Conditions
- Insomnia, Mental Health Disorder, Substance Use Disorder
- Being tested
- Quetiapine, Trazodone
- Keywords
- Quetiapine, Trazodone, Insomnia, Dual Diagnosis
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Mental Disorders, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuetiapineDrug
Also called Seroquel, Quetiapine Fumarate
Quetiapine will be administered at a dosage prescribed by veterans' current providers for the treatment of insomnia.
TrazodoneDrug
Also called Desyrel, Oleptro
Veterans willing to switch from quetiapine to trazodone for the treatment of insomnia will receive up to 400mg of trazodone daily.
| Study group | Role | What they receive |
|---|---|---|
| Quetiapine | Active comparator | Veterans remaining on quetiapine for insomnia. Receives: Drug: Quetiapine |
| Trazodone | Active comparator | Veterans switching from quetiapine to trazodone for the treatment of insomnia. Receives: Drug: Trazodone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Average Pittsburgh Sleep Quality Inventory (PSQI)Score
Data analyzed for change from score at baseline, to week 4, to week 8. The range of scores is 0-21 on this scale, with higher scores indicating worse sleep quality. Data will be presented and analyzed for those time points with the main outcome measured as the change from baseline to week 4. This is a comparison between groups (trazodone versus quetiapine)of the change on TOTAL PSQI scores over time using repeated measures analysis. This is a non-superiority analysis, so the hypothesis is that there is no significant difference between treatments. The first four weeks of treatment is the active acute experiment phase, and this will be the main comparison time period for the endpoint, but the investigators will also analyze change in PSQI until the follow-up point at the end of week 8.
Measured: From baseline (week 0) to end of 4 week and end of week 8
Secondary outcomes (8)
Change in Insomnia Severity Index (ISI) Scores
THE RANGE OF SCORES IS FROM 0-28, WITH 28 REPRESENTING SEVERE INSOMNIA SYMPTOMS. Measurements made and reported at baseline, week 2, week 4. Data will be presented and analyzed for those time points with the main outcome measured as the change from baseline to week 4. . This is a comparison between groups (trazodone versus quetiapine)of the change on TOTAL ISI scores over time using repeated measures analysis. This is a non-superiority analysis, so the hypothesis is that there is no significant difference between treatments. The investigators will first report the comparison during the active treatment phase (baseline to end of week 4) as the main comparison, but will also examine and report changes on the outcome at the follow up point (end of week 8).
Measured: from baseline (week 0) to the end of week 4 and at week 8
Change in Epworth Sleepiness Scale (ESS) Over Time
Measurements made at baseline, week 2, week 4, week 8. Data will be presented and analyzed for those time points with the main outcome measured as the change from baseline to week 4. The change from week 4 to week 8 (post-intervention) will also be measured and analyzed, reported. This is a comparison between groups (trazodone versus quetiapine)of the change on ESS scores over time using repeated measures analysis. This is a non-superiority analysis, so the hypothesis is that there is no significant difference between treatments. The investigators will first report the comparison during the active treatment phase (baseline to end of week 4) as the main comparison, but will also examine and report changes on the outcome at the follow up point (end of week 8).The minimum score on ESS is 0-24 units, with higher score representing greater sleepiness.
Measured: From baseline (week 0) to end of week 8
Change in RAND Short Form 36 Item Health Survey (RAND-SF36) General Health Subscale Over Time
Scores range from 0-100 representing percentage, with a higher score representing better functioning. Measurements made at baseline, week 2, week 4, week 8. Data will be presented and analyzed for those time points with the main outcome measured as the change from baseline to week 4. The change from week 4 to week 8 (post-intervention) will also be measured and analyzed, reported. This is a comparison between groups (trazodone versus quetiapine)of the change on RAND-SF36 scores over time. This is a non-superiority analysis, so the hypothesis is that there is no significant difference between treatments. The investigators will first report the comparison during the active treatment phase (baseline to end of week 4) as the main comparison, but will also examine and report changes on the outcome at the follow up point (end of week 8).
Measured: from week 0 (baseline) to end of week 8
Change in Brief Symptom Inventory (BSI) Over Time
The Brief Symptom Inventory scale measures a broad range of psychiatric symptoms (psychological distress) and is meant to provide an overall measure of mental health symptomatology. The BSI has 53 items that use a 5-item Likert scale response. In general, higher scores correspond to greater symptomatology and distress. Usually, the range of scores goes from 0 - 4, since it is averaged over the number of responses, however, we report the raw total score which is the sum of all responses, thus the range is 0-212. Measurements made at baseline, week 2, week 4, week 8. Data will be presented and analyzed for those time points with the main outcome measured as the change from baseline to week 4. This is a comparison between groups of the change on BSI scores over time using repeated measures analysis. This is a non-superiority analysis, so the hypothesis is that there is no significant difference between treatments.
Measured: from week 0 (baseline) to end of week 8
Change in Alcohol Urge Questionnaire (AUQ)Scores Over Time
The lowest possible score for the AUQ is 8 (representing less urge to drink) and the highest score would be a 56 (more urge to drink). Measurements made at baseline, week 2, week 4, week 8. Data will be presented and analyzed for those time points with the main outcome measured as the change from baseline to week 4. This is a comparison between groups (trazodone versus quetiapine)of the change on AUQ scores over time. This is a non-superiority analysis, so the hypothesis is that there is no significant difference between treatments. The investigators will first report the comparison during the active treatment phase (baseline to end of week 4) as the main comparison, but will also examine and report changes on the outcome at the follow up point (end of week 8).
Measured: from week 0 (baseline) to end of week 8
Percentage of Heavy Drinking Days
This is a comparison between groups of the mean percent heavy drinking days during the first 4 weeks, and then through to the follow up point (end of week 8). The investigators will first report the comparison during the active treatment phase (baseline to end of week 4) as the main comparison, but will also examine and report changes on the outcome at the follow up point (end of week 8).
Measured: from week 0 (baseline) to end of week 8
Percentage of Negative Urine Drug Screens
This is a comparison between groups of the mean percent of negative urine drug screens. The investigators will first report the comparison during the active treatment phase (baseline to end of week 4) as the main comparison, but will also examine and report changes on the outcome at the follow up point (end of week 8). THIS IS A CUMULATIVE PERCENTAGE. MAXIMUM SCORE IS 100%, MINIMUM 0%.
Measured: from week 0 (baseline) to end of week 8
Medical Outcomes Study Sleep Scale- Sleep Index (Short)
THE RANGE OF SCORES IS FROM 0-100, WITH 100 REPRESENTING SEVERE INSOMNIA SYMPTOMS. Measurements made and reported at baseline, week 2, week 4. Data will be presented and analyzed for those time points with the main outcome measured as the change from baseline to week 4. . This is a comparison between groups (trazodone versus quetiapine)of the change on TOTAL MOS-SS scores over time using repeated measures analysis. This is a non-superiority analysis, so the hypothesis is that there is no significant difference between treatments. The investigators will first report the comparison during the active treatment phase (baseline to end of week 4) as the main comparison, but will also examine and report changes on the outcome at the follow up point (end of week 8).
Measured: from baseline (week 0) to the end of week 8 sample
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2012 (estimated)
- Study startJul 2012
- Primary completionOct 2015
- Study completionOct 2015
Why it stopped: it became clear that recruitment was infeasible
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.
- Other trials for InsomniaStudies 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
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Connecticut Healthcare System
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Albert J Arias, MD, MS, Principal investigator, Yale University/Veterans Affairs CTElizabeth Ralevski, Ph.D., Study director, Yale University/Veterans Affairs CT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01662297
- Sponsor's protocol ID
- Quetiapine-Trazodone Insomnia
- Other IDs
- VA MIRB #01579
- Status last verified
- Oct 2018
- First submitted
- 16 Jul 2012
- Last updated
- 16 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Quetiapine and Trazodone Treatment for Insomnia in Dually Diagnosed Veterans: an Open (e.g. Unblinded) Randomized Stay-Switch Pilot Trial
- ClinicalTrials.gov ID
- NCT01662297
- Acronym / sponsor ID
- Quetiapine-Trazodone Insomnia
- Conditions
- Insomnia, Mental Health Disorder, Substance Use Disorder
- Keywords
- Quetiapine, Trazodone, Insomnia, Dual Diagnosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: it became clear that recruitment was infeasible
- Enrolment
- 1 participants (actual)
- Lead sponsor
- VA Connecticut Healthcare SystemUS federal agency
- Study start
- Jul 2012
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 10 Aug 2012 (estimated)
- Results
- Posted 16 Oct 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a pilot comparative effectiveness study designed to determine whether trazodone is as effective as quetiapine for treatment of insomnia in veterans with a history of addiction and mental health issues. The study will have two concurrent phases (parts); first an acceptability determination phase, to determine whether and why (or why not) veterans already taking quetiapine are willing to try an alternative to quetiapine for sleep; and second, a randomized trial phase which will test whether staying on quetiapine has any advantage over switching to trazodone. The purpose of the first phase will be a) to document the proportions of patients and physicians who are willing to agree to such a switch, b) to characterize sociodemographic and clinical characteristics of potentially eligible subjects associated with a willingness to switch from quetiapine to trazodone and c) to record the reasons given why patients and their prescribers are (or are not) willing to accept a switch from quetiapine to trazodone. It will also function to provide some educational background to patients and a reminder to providers about the potential severe side-effects of quetiapine, and will thus facilitate clinical informed consent for the clinical trial phase of the study. Completion of the first part of the study will also serve as the screening component for part II. Part II includes, first, obtaining written informed consent from eligible subjects, and then randomly assigning them to continue quetiapine or to be switched to trazodone in open-label "real world" fashion for the duration of 4 weeks, followed by another four weeks of open, non-randomized follow- up. The purpose of the second part of the study is to determine if trazodone is an adequate substitute for quetiapine, primarily in terms of treating insomnia. The investigators hypothesize that trazodone will not be inferior to quetiapine in maintaining good quality of sleep measured by sleep scales (i.e., scores will not significantly worsen once switched). This study is open to Veterans in the VA system only. Eligible subjects must have a history of "dual diagnosis" (i.e., a history of addiction and mental illness).
Detailed description
Part I of the study involves identification through VA records of subjects eligible for the study based on their prescription of quetiapine. Potentially eligible subjects will be contacted by the research team. Subjects will answer a brief questionnaire about their experience with the medication quetiapine as used for insomnia. If subjects are interested in participated in part II, the clinical trial portion of the study, they will be further screened for eligibility.
Part II consists of a 4 week clinical trial in which subjects are randomized to stay on quetiapine or switch to trazodone, all of which will be open-label. Subjects will be evaluated for symptoms of sleep quality and excessive daytime sleepiness. subjects will also be assessed for changes in mood, and alcohol/drug use. After the initial 4 week treatment period, subjects on trazodone can choose to switch back to quetiapine or continue on trazodone. Subjects will also be evaluated after an additional 4 weeks (8weeks from start of the study) on outcome measures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Quetiapine | Active comparator | Drug: QuetiapineVeterans remaining on quetiapine for insomnia. |
| Trazodone | Active comparator | Drug: TrazodoneVeterans switching from quetiapine to trazodone for the treatment of insomnia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Identified by their VA prescribing provider as taking quetiapine primarily as a sedative/hypnotic agent for some form of insomnia for at least 1 month
- Identified by their VA prescribing provider as having dual diagnosis; a lifetime history of substance use disorder and a mental disorder
- Willing to meet with a research assistant to answer several questions regarding their use of and experience with quetiapine.
- Appear not to be regularly on any medication which would be an exclusion for Part II (see Part II exclusion criteria).
- Willing to provide written informed consent.
Key exclusion criteria (11 listed)
- Physiologic substance dependence requiring detoxification in the past 30 days (substance abuse is not an exclusion).
- Concomitant administration of: other sedative hypnotics, benzodiazepines, prazosin, other atypical antipsychotics, stimulants, ketoconazole and other inhibitors of cytochrome P450 3A (e.g., itraconazole, fluconazole, erythromycin, and protease inhibitors), phenytoin or other strong inducers of cytochrome P450 enzymes.
- Intolerance or hypersensitivity to trazodone.
- Pregnant or lactating women or women planning to become pregnant.
- Hepatic or renal problems AST or ALT (>3 times upper limit of normal);
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 |
|---|---|---|
| QuetiapineAlso: Seroquel, Quetiapine FumarateQuetiapine will be administered at a dosage prescribed by veterans' current providers for the treatment of insomnia. | Drug | Quetiapine |
| TrazodoneAlso: Desyrel, OleptroVeterans willing to switch from quetiapine to trazodone for the treatment of insomnia will receive up to 400mg of trazodone daily. | Drug | Trazodone |
Primary outcome
Change in Average Pittsburgh Sleep Quality Inventory (PSQI)Score
Time frame: From baseline (week 0) to end of 4 week and end of week 8
Data analyzed for change from score at baseline, to week 4, to week 8. The range of scores is 0-21 on this scale, with higher scores indicating worse sleep quality. Data will be presented and analyzed for those time points with the main outcome measured as the change from baseline to week 4. This is a comparison between groups (trazodone versus quetiapine)of the change on TOTAL PSQI scores over time using repeated measures analysis. This is a non-superiority analysis, so the hypothesis is that there is no significant difference between treatments. The first four weeks of treatment is the active acute experiment phase, and this will be the main comparison time period for the endpoint, but the investigators will also analyze change in PSQI until the follow-up point at the end of week 8.
8 secondary outcomes
Change in Insomnia Severity Index (ISI) Scores
Time frame: from baseline (week 0) to the end of week 4 and at week 8
Change in Epworth Sleepiness Scale (ESS) Over Time
Time frame: From baseline (week 0) to end of week 8
Change in RAND Short Form 36 Item Health Survey (RAND-SF36) General Health Subscale Over Time
Time frame: from week 0 (baseline) to end of week 8
Change in Brief Symptom Inventory (BSI) Over Time
Time frame: from week 0 (baseline) to end of week 8
Change in Alcohol Urge Questionnaire (AUQ)Scores Over Time
Time frame: from week 0 (baseline) to end of week 8
Percentage of Heavy Drinking Days
Time frame: from week 0 (baseline) to end of week 8
Percentage of Negative Urine Drug Screens
Time frame: from week 0 (baseline) to end of week 8
Medical Outcomes Study Sleep Scale- Sleep Index (Short)
Time frame: from baseline (week 0) to the end of week 8 sample
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Insomnia
Recruiting
Addressing Nocturia in Older Women Utilizing Behavioral Sleep Intervention and Brief Mindfulness
Nocturia, Insomnia
Not yet recruiting
A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders
Recruiting
Effect of Cyclic Sighing Breathing Exercise on CRBD, Pain, and Sleep Quality in Patients Undergoing TUR
Transurethral Resection of Bladder Tumor, Transurethral Resection of the Prostate (TURP)
Recruiting
Evaluation of Cognitive Behavioral Therapy for Insomnia (CBT-I) in Individuals With Mild Traumatic Brain Injury (mTBI)
Sleep Architecture, Mild Traumatic Brain Injury
RecruitingPhase 3
A Trial to See if Daridorexant Can Help Adults and Elderly People With Insomnia Sleep Better During the Night and Function Better During the Day
Insomia Disorder
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.
Albert J Arias, MD, MS principal investigator
Yale University/Veterans Affairs CT
Elizabeth Ralevski, Ph.D. study director
Yale University/Veterans Affairs CT
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Quetiapine and Trazodone in people with Insomnia and Mental Health Disorder, run by VA Connecticut Healthcare System 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 10 inclusion and 11 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: stopped early, as of the sponsor's last update on 16 Oct 2018. 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. 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 16 Oct 2018). 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 in Average Pittsburgh Sleep Quality Inventory (PSQI)Score (time frame: From baseline (week 0) to end of 4 week and end of week 8). 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 16 Oct 2018.