Trial Outcomes & Findings for Comparison of Quetiapine and Trazodone Treatment for Insomnia in Dually Diagnosed Veterans (NCT NCT01662297)
NCT ID: NCT01662297
Last Updated: 2018-10-16
Results Overview
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.
TERMINATED
PHASE4
1 participants
From baseline (week 0) to end of 4 week and end of week 8
2018-10-16
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
0
|
1
|
|
Overall Study
COMPLETED
|
0
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparison of Quetiapine and Trazodone Treatment for Insomnia in Dually Diagnosed Veterans
Baseline characteristics by cohort
| Measure |
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.
|
Trazodone
n=1 Participants
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.
|
Total
n=1 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
—
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
—
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
—
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
—
|
60 years
n=7 Participants
|
60 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
—
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
—
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
—
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From baseline (week 0) to end of 4 week and end of week 8Population: We had difficulty recruiting and retaining subjects for this study. 3 subjects were randomized and only 1 provided data beyond baseline.
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.
Outcome measures
| Measure |
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.
|
Trazodone
n=1 Participants
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.
|
|---|---|---|
|
Change in Average Pittsburgh Sleep Quality Inventory (PSQI)Score
change at week 8
|
—
|
-11 units on a scale
Standard Deviation 0
|
|
Change in Average Pittsburgh Sleep Quality Inventory (PSQI)Score
change at week 4
|
—
|
-11 units on a scale
Standard Deviation 0
|
SECONDARY outcome
Timeframe: from baseline (week 0) to the end of week 4 and at week 8Population: We had difficulty recruiting and retaining subjects for this study. 3 subjects were randomized and only 1 provided data beyond baseline.
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).
Outcome measures
| Measure |
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.
|
Trazodone
n=1 Participants
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.
|
|---|---|---|
|
Change in Insomnia Severity Index (ISI) Scores
change at week 4
|
—
|
-14 units on a scale
Standard Deviation 0
|
|
Change in Insomnia Severity Index (ISI) Scores
change at week 8
|
—
|
-16 units on a scale
Standard Deviation 0
|
SECONDARY outcome
Timeframe: From baseline (week 0) to end of week 8Population: We had difficulty recruiting and retaining subjects for this study. 3 subjects were randomized and only 1 provided data beyond baseline.
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.
Outcome measures
| Measure |
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.
|
Trazodone
n=1 Participants
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.
|
|---|---|---|
|
Change in Epworth Sleepiness Scale (ESS) Over Time
change at week 8
|
—
|
-4 units on a scale
Standard Deviation 0
|
|
Change in Epworth Sleepiness Scale (ESS) Over Time
change at week 4
|
—
|
-3 units on a scale
Standard Deviation 0
|
SECONDARY outcome
Timeframe: from week 0 (baseline) to end of week 8Population: We had difficulty recruiting and retaining subjects for this study. 3 subjects were randomized and only 1 provided data beyond baseline.
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).
Outcome measures
| Measure |
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.
|
Trazodone
n=1 Participants
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.
|
|---|---|---|
|
Change in RAND Short Form 36 Item Health Survey (RAND-SF36) General Health Subscale Over Time
change at week 4
|
—
|
15 percentage of total points possible
Standard Deviation 0
|
|
Change in RAND Short Form 36 Item Health Survey (RAND-SF36) General Health Subscale Over Time
change at week 8
|
—
|
0 percentage of total points possible
Standard Deviation 0
|
SECONDARY outcome
Timeframe: from week 0 (baseline) to end of week 8Population: We had difficulty recruiting and retaining subjects for this study. 3 subjects were randomized and only 1 provided data beyond baseline.
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.
Outcome measures
| Measure |
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.
|
Trazodone
n=1 Participants
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.
|
|---|---|---|
|
Change in Brief Symptom Inventory (BSI) Over Time
change at week 4
|
—
|
-48 units on a scale
|
|
Change in Brief Symptom Inventory (BSI) Over Time
change at week 8
|
—
|
-48 units on a scale
|
SECONDARY outcome
Timeframe: from week 0 (baseline) to end of week 8Population: We had difficulty recruiting and retaining subjects for this study. 3 subjects were randomized and only 1 provided data beyond baseline.
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).
Outcome measures
| Measure |
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.
|
Trazodone
n=1 Participants
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.
|
|---|---|---|
|
Change in Alcohol Urge Questionnaire (AUQ)Scores Over Time
change after week 4
|
—
|
-1 units on a scale
Standard Deviation 0
|
|
Change in Alcohol Urge Questionnaire (AUQ)Scores Over Time
change after week 8
|
—
|
-12 units on a scale
Standard Deviation 0
|
SECONDARY outcome
Timeframe: from week 0 (baseline) to end of week 8Population: We had difficulty recruiting and retaining subjects for this study. 3 subjects were randomized and only 1 provided data beyond baseline.
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).
Outcome measures
| Measure |
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.
|
Trazodone
n=1 Participants
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.
|
|---|---|---|
|
Percentage of Heavy Drinking Days
percentage at week 4
|
—
|
0 percentage of heavy drinking days
Standard Deviation 0
|
|
Percentage of Heavy Drinking Days
percentage at week 8
|
—
|
0 percentage of heavy drinking days
Standard Deviation 0
|
SECONDARY outcome
Timeframe: from week 0 (baseline) to end of week 8Population: We had difficulty recruiting and retaining subjects for this study. 3 subjects were randomized and only 1 provided data beyond baseline.
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%.
Outcome measures
| Measure |
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.
|
Trazodone
n=1 Participants
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.
|
|---|---|---|
|
Percentage of Negative Urine Drug Screens
cumulative percentage at week 4
|
—
|
0 percentage of tests
Standard Deviation 0
|
|
Percentage of Negative Urine Drug Screens
cumulative percentage at week 8
|
—
|
0 percentage of tests
Standard Deviation 0
|
SECONDARY outcome
Timeframe: from baseline (week 0) to the end of week 8 samplePopulation: We had difficulty recruiting and retaining subjects for this study. 3 subjects were randomized and only 1 provided data beyond baseline.
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).
Outcome measures
| Measure |
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.
|
Trazodone
n=1 Participants
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.
|
|---|---|---|
|
Medical Outcomes Study Sleep Scale- Sleep Index (Short)
change at 4 weeks
|
—
|
-13.33 units on a scale
Standard Deviation 0
|
|
Medical Outcomes Study Sleep Scale- Sleep Index (Short)
change at 8 weeks
|
—
|
-26.66 units on a scale
Standard Deviation 0
|
Adverse Events
Quetiapine
Trazodone
Serious adverse events
| Measure |
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.
|
Trazodone
n=1 participants at risk
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.
|
|---|---|---|
|
Cardiac disorders
Death
|
—
0/0 • 8 weeks
|
100.0%
1/1 • Number of events 1 • 8 weeks
|
Other adverse events
| Measure |
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.
|
Trazodone
n=1 participants at risk
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.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea/Vomiting
|
—
0/0 • 8 weeks
|
100.0%
1/1 • Number of events 1 • 8 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place