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| ID | Type | Description | Link |
|---|---|---|---|
| VA MIRB #01579 | Other Identifier | VA MIRB #01579 |
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it became clear that recruitment was infeasible
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Quetiapine | Active Comparator | Veterans remaining on quetiapine for insomnia. |
|
| Trazodone | Active Comparator | Veterans switching from quetiapine to trazodone for the treatment of insomnia. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quetiapine | Drug | Quetiapine will be administered at a dosage prescribed by veterans' current providers for the treatment of insomnia. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From baseline (week 0) to end of 4 week and end of week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion/Exclusion Criteria (PHASE 1):
Inclusion Criteria (PHASE 2):
Exclusion Criteria (PHASE 2):
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| Name | Affiliation | Role |
|---|---|---|
| Albert J Arias, MD, MS | Yale University/Veterans Affairs CT | Principal Investigator |
| Elizabeth Ralevski, Ph.D. | Yale University/Veterans Affairs CT | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Connecticut Healthcare System | West Haven | Connecticut | 06516 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Quetiapine | Veterans remaining on quetiapine for insomnia. Quetiapine: Quetiapine will be administered at a dosage prescribed by veterans' current providers for the treatment of insomnia. |
| FG001 | Trazodone | Veterans switching from quetiapine to trazodone for the treatment of insomnia. Trazodone: Veterans willing to switch from quetiapine to trazodone for the treatment of insomnia will receive up to 400mg of trazodone daily. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Quetiapine | Veterans remaining on quetiapine for insomnia. Quetiapine: Quetiapine will be administered at a dosage prescribed by veterans' current providers for the treatment of insomnia. |
| BG001 | Trazodone |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | We had difficulty recruiting and retaining subjects for this study. 3 subjects were randomized and only 1 provided data beyond baseline. | Posted | Mean | Standard Deviation | units on a scale | From baseline (week 0) to end of 4 week and end of week 8 |
|
8 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Quetiapine | Veterans remaining on quetiapine for insomnia. Quetiapine: Quetiapine will be administered at a dosage prescribed by veterans' current providers for the treatment of insomnia. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | Cardiac disorders | Systematic Assessment | This patient died after completing the study and the 8 week follow up session. Subject died on 4/30/2013, several weeks after completing the follow up period for the study (4/8/13). The death was clearly unrelated to study participation. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea/Vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Albert Arias | Yale University/West Haven VAMC | 2039325711 | 8155 | albert.arias@va.gov |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| D001523 | Mental Disorders |
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000069348 | Quetiapine Fumarate |
| D014196 | Trazodone |
| ID | Term |
|---|---|
| D003987 | Dibenzothiazepines |
| D013841 | Thiazepines |
| D013846 | Thiepins |
| D013457 | Sulfur Compounds |
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| Trazodone | Drug | Veterans willing to switch from quetiapine to trazodone for the treatment of insomnia will receive up to 400mg of trazodone daily. |
|
|
| 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. | 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). | 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. | 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). | 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). | 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%. | 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). | from baseline (week 0) to the end of week 8 sample |
Veterans switching from quetiapine to trazodone for the treatment of insomnia.
Trazodone: Veterans willing to switch from quetiapine to trazodone for the treatment of insomnia will receive up to 400mg of trazodone daily.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG000 | Quetiapine | Veterans remaining on quetiapine for insomnia. Quetiapine: Quetiapine will be administered at a dosage prescribed by veterans' current providers for the treatment of insomnia. |
| OG001 | Trazodone | Veterans switching from quetiapine to trazodone for the treatment of insomnia. Trazodone: Veterans willing to switch from quetiapine to trazodone for the treatment of insomnia will receive up to 400mg of trazodone daily. |
|
|
| Secondary | 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). | We had difficulty recruiting and retaining subjects for this study. 3 subjects were randomized and only 1 provided data beyond baseline. | Posted | Mean | Standard Deviation | units on a scale | from baseline (week 0) to the end of week 4 and at week 8 |
|
|
|
| Secondary | 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. | We had difficulty recruiting and retaining subjects for this study. 3 subjects were randomized and only 1 provided data beyond baseline. | Posted | Mean | Standard Deviation | units on a scale | From baseline (week 0) to end of week 8 |
|
|
|
| Secondary | 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). | We had difficulty recruiting and retaining subjects for this study. 3 subjects were randomized and only 1 provided data beyond baseline. | Posted | Mean | Standard Deviation | percentage of total points possible | from week 0 (baseline) to end of week 8 |
|
|
|
| Secondary | 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. | We had difficulty recruiting and retaining subjects for this study. 3 subjects were randomized and only 1 provided data beyond baseline. | Posted | Mean | Standard Deviation | units on a scale | from week 0 (baseline) to end of week 8 |
|
|
|
| Secondary | 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). | We had difficulty recruiting and retaining subjects for this study. 3 subjects were randomized and only 1 provided data beyond baseline. | Posted | Mean | Standard Deviation | units on a scale | from week 0 (baseline) to end of week 8 |
|
|
|
| Secondary | 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). | We had difficulty recruiting and retaining subjects for this study. 3 subjects were randomized and only 1 provided data beyond baseline. | Posted | Mean | Standard Deviation | percentage of heavy drinking days | from week 0 (baseline) to end of week 8 |
|
|
|
| Secondary | 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%. | We had difficulty recruiting and retaining subjects for this study. 3 subjects were randomized and only 1 provided data beyond baseline. | Posted | Mean | Standard Deviation | percentage of tests | from week 0 (baseline) to end of week 8 |
|
|
|
| Secondary | 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). | We had difficulty recruiting and retaining subjects for this study. 3 subjects were randomized and only 1 provided data beyond baseline. | Posted | Mean | Standard Deviation | units on a scale | from baseline (week 0) to the end of week 8 sample |
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| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Trazodone | Veterans switching from quetiapine to trazodone for the treatment of insomnia. Trazodone: Veterans willing to switch from quetiapine to trazodone for the treatment of insomnia will receive up to 400mg of trazodone daily. | 1 | 1 | 1 | 1 |
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| D064419 |
| Chemically-Induced Disorders |
| D009930 |
| Organic Chemicals |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D011728 | Pyridones |
| D011725 | Pyridines |