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Trial record 60 of 450 for:    QUETIAPINE

The Effects of Quetiapine (Seroquel XR) on Sleep During Alcohol Abstinence

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00434876
Recruitment Status : Completed
First Posted : February 14, 2007
Results First Posted : August 9, 2013
Last Update Posted : August 9, 2013
Sponsor:
Information provided by (Responsible Party):
Subhajit Chakravorty, Corporal Michael J. Crescenz VA Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Alcoholism
Sleep Initiation and Maintenance Disorders
Interventions Drug: Quetiapine XR
Drug: Placebo.
Enrollment 22
Recruitment Details Addiction psychiatry clinic, behavioral health laboratory, and self referrals solicited through flyers.
Pre-assignment Details  
Arm/Group Title Quetiapine XR Placebo
Hide Arm/Group Description The pills were taken at bedtime and the dose was titrated flexibly in the following fashion over the first week: 50 mg dose for 2 nights, followed by 200 mg a night for 2 nights, and then 300 mg a night for 2 nights and to a final dose of 400 mg daily starting on night # 7. Medication taper commenced at week 8 in the reverse stepwise fashion after the second set of two polysomnograms. The matching placebo pills were similarly taken at bedtime and the dose was titrated flexibly in the following fashion over the first week: 50 mg dose for 2 nights, followed by 200 mg a night for 2 nights, and then 300 mg a night for 2 nights and to a final dose of 400 mg daily starting on night # 7. Medication taper commenced at week 8 in the reverse stepwise fashion after the second set of two polysomnograms.
Period Title: Overall Study
Started 11 11
Completed 10 10
Not Completed 1 1
Reason Not Completed
Lost to Follow-up             1             1
Arm/Group Title Quetiapine Placebo Total
Hide Arm/Group Description Quetiapine XR Placebo Total of all reporting groups
Overall Number of Baseline Participants 10 10 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
10
 100.0%
10
 100.0%
20
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 10 participants 20 participants
53  (6) 51  (8) 52  (7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
10
 100.0%
10
 100.0%
20
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants 10 participants 20 participants
10 10 20
1.Primary Outcome
Title Sleep Efficiency (From an In-laboratory Polysomnogram)
Hide Description The fraction of time spent asleep to the total time in bed (%).
Time Frame Baseline, and week 8 of treatment.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Quetiapine XR Placebo
Hide Arm/Group Description:
Quetiapine XR
Placebo
Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: percentage
Sleep Efficiency (baseline) 70.70  (17.49) 78.63  (12.89)
Sleep Efficiency (after 8 weeks of treatment) 79.45  (16.52) 82.80  (11.57)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Quetiapine XR, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.49
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
2.Secondary Outcome
Title Insomnia Severity Index (ISI)
Hide Description ISI total score; this scale assesses for global insomnia severity (range 0-24). Higher scale scores indicate higher insomnia severity.
Time Frame Baseline, weeks 1, 3, 5, and 7 of treatment.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Quetiapine XR Placebo
Hide Arm/Group Description:
Quetiapine XR
Placebo
Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: units on a scale
ISI (baseline) 17.00  (4.08) 14.80  (7.14)
ISI (week 7) 5.40  (4.83) 6.70  (7.34)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Quetiapine XR, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.04
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
3.Secondary Outcome
Title Pittsburgh Sleep Quality Index (PSQI)
Hide Description

PSQI total score (range 0-21). A PSQI total score > 5 indicates insomnia, with higher scores denoting a decrease in sleep quality.

The PSQI global score assesses for the overall quality of sleep and is computed by adding the 7 component scale scores. This widely used 19-item self-rated scale evaluates the subjective quality of sleep over the last 4 weeks. The PSQI was administered at baseline, and weeks 4, and 9.

Time Frame Baseline, weeks 4, and 9.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Quetiapine XR Placebo
Hide Arm/Group Description:
Quetiapine XR
Placebo
Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: units on a scale
PSQI (baseline) 14.70  (1.94) 14.60  (1.71)
PSQI (week 4) 13.20  (2.61) 13.80  (2.04)
PSQI (week 9) 14.50  (2.56) 13.80  (2.78)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Quetiapine XR, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.57
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
4.Secondary Outcome
Title Wake After Sleep Onset Time (WASO) From an In-laboratory Polysomnogram.
Hide Description The amount of time spent awake after initially falling asleep and before final awakening (in minutes). None to a fewer minutes is better (than a higher number of minutes).
Time Frame Baseline, and week 8
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Quetiapine XR Placebo
Hide Arm/Group Description:
Quetiapine XR
Placebo
Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: minutes
WASO (baseline) 101.87  (81.80) 61.17  (37.77)
WASO (week 8) 60.71  (71.41) 66.99  (60.62)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Quetiapine XR, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.03
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Quetiapine Placebo
Hide Arm/Group Description Quetiapine XR Placebo
All-Cause Mortality
Quetiapine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Quetiapine Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/10 (20.00%)      2/10 (20.00%)    
Psychiatric disorders     
Suicidal ideation   1/10 (10.00%)  1 1/10 (10.00%)  1
Relapse to heavy alcohol use leading to inpatient admission   1/10 (10.00%)  1 1/10 (10.00%)  1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Quetiapine Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/10 (70.00%)      3/10 (30.00%)    
Cardiac disorders     
Dizziness   1/10 (10.00%)  1/10 (10.00%) 
Gastrointestinal disorders     
Dry mouth   2/10 (20.00%)  0/10 (0.00%) 
Constipation   1/10 (10.00%)  0/10 (0.00%) 
General disorders     
Fatigue   2/10 (20.00%)  0/10 (0.00%) 
Musculoskeletal and connective tissue disorders     
Somatic pain   1/10 (10.00%)  0/10 (0.00%) 
Nervous system disorders     
Headache  0/10 (0.00%)  1/10 (10.00%) 
Psychiatric disorders     
Somnolence   7/10 (70.00%)  3/10 (30.00%) 
Insomnia   2/10 (20.00%)  0/10 (0.00%) 
Increased apetite   1/10 (10.00%)  0/10 (0.00%) 
Agitation   1/10 (10.00%)  0/10 (0.00%) 
Decreased motivation   0/10 (0.00%)  1/10 (10.00%) 
Indicates events were collected by systematic assessment
The limitations of this study include the small sample size, and assessment of PSQI, PHQ-9, BAI, and SF-12 at week 9 (immediately after washout from the study drug). The corruption of stored online actigraphic sleep data prevented its interpretation.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Subhajit Chakravorty
Organization: Philadelphia VAMC
Phone: 215-823-5800 ext 3405
EMail: Subhajit.Chakravorty@va.gov
Layout table for additonal information
Responsible Party: Subhajit Chakravorty, Corporal Michael J. Crescenz VA Medical Center
ClinicalTrials.gov Identifier: NCT00434876     History of Changes
Other Study ID Numbers: 101206
First Submitted: February 12, 2007
First Posted: February 14, 2007
Results First Submitted: May 16, 2013
Results First Posted: August 9, 2013
Last Update Posted: August 9, 2013