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Trial record 5 of 450 for:    QUETIAPINE

Comparison of Quetiapine and Trazodone Treatment for Insomnia in Dually Diagnosed Veterans

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ClinicalTrials.gov Identifier: NCT01662297
Recruitment Status : Terminated (it became clear that recruitment was infeasible)
First Posted : August 10, 2012
Results First Posted : October 16, 2018
Last Update Posted : October 16, 2018
Sponsor:
Information provided by (Responsible Party):
VA Connecticut Healthcare System

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Insomnia
Mental Health Disorder
Substance Use Disorder
Interventions Drug: Quetiapine
Drug: Trazodone
Enrollment 1
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Quetiapine Trazodone
Hide Arm/Group Description

Veterans remaining on quetiapine for insomnia.

Quetiapine: Quetiapine will be administered at a dosage prescribed by veterans' current providers for the treatment of insomnia.

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.

Period Title: Overall Study
Started 0 1
Completed 0 1
Not Completed 0 0
Arm/Group Title Quetiapine Trazodone Total
Hide Arm/Group Description

Veterans remaining on quetiapine for insomnia.

Quetiapine: Quetiapine will be administered at a dosage prescribed by veterans' current providers for the treatment of insomnia.

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 of all reporting groups
Overall Number of Baseline Participants 0 1 1
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 1 participants 1 participants
<=18 years
0
   0.0%
0
   0.0%
Between 18 and 65 years
1
 100.0%
1
 100.0%
>=65 years
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 0 participants 1 participants 1 participants
60
(60 to 60)
60
(60 to 60)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 1 participants 1 participants
Female
0
   0.0%
0
   0.0%
Male
1
 100.0%
1
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 0 participants 1 participants 1 participants
1 1
1.Primary Outcome
Title Change in Average Pittsburgh Sleep Quality Inventory (PSQI)Score
Hide Description 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.
Time Frame From baseline (week 0) to end of 4 week and end of week 8
Hide Outcome Measure Data
Hide Analysis Population Description
We had difficulty recruiting and retaining subjects for this study. 3 subjects were randomized and only 1 provided data beyond baseline.
Arm/Group Title Quetiapine Trazodone
Hide Arm/Group Description:

Veterans remaining on quetiapine for insomnia.

Quetiapine: Quetiapine will be administered at a dosage prescribed by veterans' current providers for the treatment of insomnia.

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 Number of Participants Analyzed 0 1
Mean (Standard Deviation)
Unit of Measure: units on a scale
change at week 4 -11  (0)
change at week 8 -11  (0)
2.Secondary Outcome
Title Change in Insomnia Severity Index (ISI) Scores
Hide Description 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).
Time Frame from baseline (week 0) to the end of week 4 and at week 8
Hide Outcome Measure Data
Hide Analysis Population Description
We had difficulty recruiting and retaining subjects for this study. 3 subjects were randomized and only 1 provided data beyond baseline.
Arm/Group Title Quetiapine Trazodone
Hide Arm/Group Description:

Veterans remaining on quetiapine for insomnia.

Quetiapine: Quetiapine will be administered at a dosage prescribed by veterans' current providers for the treatment of insomnia.

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 Number of Participants Analyzed 0 1
Mean (Standard Deviation)
Unit of Measure: units on a scale
change at week 4 -14  (0)
change at week 8 -16  (0)
3.Secondary Outcome
Title Change in Epworth Sleepiness Scale (ESS) Over Time
Hide Description 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.
Time Frame From baseline (week 0) to end of week 8
Hide Outcome Measure Data
Hide Analysis Population Description
We had difficulty recruiting and retaining subjects for this study. 3 subjects were randomized and only 1 provided data beyond baseline.
Arm/Group Title Quetiapine Trazodone
Hide Arm/Group Description:

Veterans remaining on quetiapine for insomnia.

Quetiapine: Quetiapine will be administered at a dosage prescribed by veterans' current providers for the treatment of insomnia.

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 Number of Participants Analyzed 0 1
Mean (Standard Deviation)
Unit of Measure: units on a scale
change at week 4 -3  (0)
change at week 8 -4  (0)
4.Secondary Outcome
Title Change in RAND Short Form 36 Item Health Survey (RAND-SF36) General Health Subscale Over Time
Hide Description 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).
Time Frame from week 0 (baseline) to end of week 8
Hide Outcome Measure Data
Hide Analysis Population Description
We had difficulty recruiting and retaining subjects for this study. 3 subjects were randomized and only 1 provided data beyond baseline.
Arm/Group Title Quetiapine Trazodone
Hide Arm/Group Description:

Veterans remaining on quetiapine for insomnia.

Quetiapine: Quetiapine will be administered at a dosage prescribed by veterans' current providers for the treatment of insomnia.

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 Number of Participants Analyzed 0 1
Mean (Standard Deviation)
Unit of Measure: percentage of total points possible
change at week 4 15  (0)
change at week 8 0  (0)
5.Secondary Outcome
Title Change in Brief Symptom Inventory (BSI) Over Time
Hide Description 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.
Time Frame from week 0 (baseline) to end of week 8
Hide Outcome Measure Data
Hide Analysis Population Description
We had difficulty recruiting and retaining subjects for this study. 3 subjects were randomized and only 1 provided data beyond baseline.
Arm/Group Title Quetiapine Trazodone
Hide Arm/Group Description:

Veterans remaining on quetiapine for insomnia.

Quetiapine: Quetiapine will be administered at a dosage prescribed by veterans' current providers for the treatment of insomnia.

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 Number of Participants Analyzed 0 1
Mean (Standard Deviation)
Unit of Measure: units on a scale
change at week 4 -48
change at week 8 -48
6.Secondary Outcome
Title Change in Alcohol Urge Questionnaire (AUQ)Scores Over Time
Hide Description 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).
Time Frame from week 0 (baseline) to end of week 8
Hide Outcome Measure Data
Hide Analysis Population Description
We had difficulty recruiting and retaining subjects for this study. 3 subjects were randomized and only 1 provided data beyond baseline.
Arm/Group Title Quetiapine Trazodone
Hide Arm/Group Description:

Veterans remaining on quetiapine for insomnia.

Quetiapine: Quetiapine will be administered at a dosage prescribed by veterans' current providers for the treatment of insomnia.

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 Number of Participants Analyzed 0 1
Mean (Standard Deviation)
Unit of Measure: units on a scale
change after week 4 -1  (0)
change after week 8 -12  (0)
7.Secondary Outcome
Title Percentage of Heavy Drinking Days
Hide Description 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).
Time Frame from week 0 (baseline) to end of week 8
Hide Outcome Measure Data
Hide Analysis Population Description
We had difficulty recruiting and retaining subjects for this study. 3 subjects were randomized and only 1 provided data beyond baseline.
Arm/Group Title Quetiapine Trazodone
Hide Arm/Group Description:

Veterans remaining on quetiapine for insomnia.

Quetiapine: Quetiapine will be administered at a dosage prescribed by veterans' current providers for the treatment of insomnia.

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 Number of Participants Analyzed 0 1
Mean (Standard Deviation)
Unit of Measure: percentage of heavy drinking days
percentage at week 4 0  (0)
percentage at week 8 0  (0)
8.Secondary Outcome
Title Percentage of Negative Urine Drug Screens
Hide Description 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%.
Time Frame from week 0 (baseline) to end of week 8
Hide Outcome Measure Data
Hide Analysis Population Description
We had difficulty recruiting and retaining subjects for this study. 3 subjects were randomized and only 1 provided data beyond baseline.
Arm/Group Title Quetiapine Trazodone
Hide Arm/Group Description:

Veterans remaining on quetiapine for insomnia.

Quetiapine: Quetiapine will be administered at a dosage prescribed by veterans' current providers for the treatment of insomnia.

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 Number of Participants Analyzed 0 1
Mean (Standard Deviation)
Unit of Measure: percentage of tests
cumulative percentage at week 4 0  (0)
cumulative percentage at week 8 0  (0)
9.Secondary Outcome
Title Medical Outcomes Study Sleep Scale- Sleep Index (Short)
Hide Description 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).
Time Frame from baseline (week 0) to the end of week 8 sample
Hide Outcome Measure Data
Hide Analysis Population Description
We had difficulty recruiting and retaining subjects for this study. 3 subjects were randomized and only 1 provided data beyond baseline.
Arm/Group Title Quetiapine Trazodone
Hide Arm/Group Description:

Veterans remaining on quetiapine for insomnia.

Quetiapine: Quetiapine will be administered at a dosage prescribed by veterans' current providers for the treatment of insomnia.

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 Number of Participants Analyzed 0 1
Mean (Standard Deviation)
Unit of Measure: units on a scale
change at 4 weeks -13.33  (0)
change at 8 weeks -26.66  (0)
Time Frame 8 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Quetiapine Trazodone
Hide Arm/Group Description

Veterans remaining on quetiapine for insomnia.

Quetiapine: Quetiapine will be administered at a dosage prescribed by veterans' current providers for the treatment of insomnia.

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.

All-Cause Mortality
Quetiapine Trazodone
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Quetiapine Trazodone
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/0      1/1 (100.00%)    
Cardiac disorders     
Death  [1]  0/0  0 1/1 (100.00%)  1
Indicates events were collected by systematic assessment
[1]
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.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Quetiapine Trazodone
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/0      1/1 (100.00%)    
Gastrointestinal disorders     
Nausea/Vomiting   0/0  0 1/1 (100.00%)  1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Albert Arias
Organization: Yale University/West Haven VAMC
Phone: 2039325711 ext 8155
EMail: albert.arias@va.gov
Layout table for additonal information
Responsible Party: VA Connecticut Healthcare System
ClinicalTrials.gov Identifier: NCT01662297     History of Changes
Other Study ID Numbers: Quetiapine-Trazodone Insomnia
VA MIRB #01579 ( Other Identifier: VA MIRB #01579 )
First Submitted: July 16, 2012
First Posted: August 10, 2012
Results First Submitted: October 19, 2015
Results First Posted: October 16, 2018
Last Update Posted: October 16, 2018