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Trial record 67 of 450 for:    QUETIAPINE

Study of the Effectiveness of Quetiapine for the Treatment of Alcohol Dependency

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: NCT00498628
Recruitment Status : Completed
First Posted : July 10, 2007
Results First Posted : May 30, 2012
Last Update Posted : March 19, 2019
Sponsor:
Collaborators:
National Institute on Drug Abuse (NIDA)
AstraZeneca
US Department of Veterans Affairs
Information provided by (Responsible Party):
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Conditions Alcoholism
Alcohol Abuse
Interventions Drug: Quetiapine fumarate
Other: Placebo
Enrollment 224
Recruitment Details Interested candidates responded by telephone to advertisements at 5 academic centers in the United States between December 2007 and May 2009.
Pre-assignment Details 218 comprises the Modified Intent To Treat group (MITT)
Arm/Group Title Quetiapine Fumerate Plus Medical Management Sugar Pill Plus Medical Management
Hide Arm/Group Description Quetiapine fumarate - target dose 400mg/day plus medical management Medical management plus placebo comparator
Period Title: Overall Study
Started 105 113
Completed 90 92
Not Completed 15 21
Arm/Group Title Quetiapine Fumerate Plus Medical Management Sugar Pill Plus Medical Management Total
Hide Arm/Group Description Quetiapine fumarate - target dose 400mg/day plus medical management Medical management plus placebo comparator Total of all reporting groups
Overall Number of Baseline Participants 105 113 218
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 105 participants 113 participants 218 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
105
 100.0%
113
 100.0%
218
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 105 participants 113 participants 218 participants
45.4  (9.3) 45.5  (9.8) 45.4  (9.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 105 participants 113 participants 218 participants
Female
17
  16.2%
26
  23.0%
43
  19.7%
Male
88
  83.8%
87
  77.0%
175
  80.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 105 participants 113 participants 218 participants
105 113 218
1.Primary Outcome
Title Percent Heavy Drinking Days
Hide Description A heavy drinking day is defined as 5 or more drinks for men and 4 or more drinks for women during a 24 hour period.
Time Frame Weeks 3 - 11
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Intention to Treat
Arm/Group Title Quetiapine Fumerate Plus Medical Management Sugar Pill Plus Medical Management
Hide Arm/Group Description:
Quetiapine fumarate - target dose 400mg/day plus medical management
Medical management plus placebo comparator
Overall Number of Participants Analyzed 105 113
Least Squares Mean (Standard Error)
Unit of Measure: percentage of heavy drinking days
37.1  (3.5) 37.9  (3.34)
2.Secondary Outcome
Title Percent Days Abstinent
Hide Description Timeline Follow-back drinking data is used to calculate the % of days abstinent per week during Weeks 3-11
Time Frame Weeks 3-11
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Quetiapine Fumerate Plus Medical Management Sugar Pill Plus Medical Management
Hide Arm/Group Description:
Quetiapine fumarate - target dose 400mg/day plus medical management
Medical management plus placebo comparator
Overall Number of Participants Analyzed 105 113
Least Squares Mean (Standard Error)
Unit of Measure: percentage of days abstinent
49.5  (3.71) 47.1  (3.54)
3.Secondary Outcome
Title Drinks Per Drinking Day
Hide Description Timeline Follow Back daily drinking data used to calculate the weekly mean drinks per drinking day
Time Frame Study Weeks 3-11
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Quetiapine Fumerate Plus Medical Management Sugar Pill Plus Medical Management
Hide Arm/Group Description:
Quetiapine fumarate - target dose 400mg/day plus medical management
Medical management plus placebo comparator
Overall Number of Participants Analyzed 105 113
Least Squares Mean (Standard Error)
Unit of Measure: drinks per drinking day
6.2  (.47) 6.3  (.45)
4.Secondary Outcome
Title Drinks Per Day
Hide Description Timeline Follow Back daily drinking data used to calculate the weekly mean drinks per day
Time Frame Study Weeks 3-11
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Quetiapine Fumerate Plus Medical Management Sugar Pill Plus Medical Management
Hide Arm/Group Description:
Quetiapine fumarate - target dose 400mg/day plus medical management
Medical management plus placebo comparator
Overall Number of Participants Analyzed 105 113
Least Squares Mean (Standard Error)
Unit of Measure: drinks per day
4.3  (0.43) 4.4  (0.41)
5.Secondary Outcome
Title Percent Very Heavy Drinking Day
Hide Description Timeline Follow Back data used to calculate the % of very heavy drinking days per week. Heavy drinking is 10+ drinks per day for females and 12+ drinks per day for males
Time Frame Study Weeks 3-11
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Quetiapine Fumerate Plus Medical Management Sugar Pill Plus Medical Management
Hide Arm/Group Description:
Quetiapine fumarate - target dose 400mg/day plus medical management
Medical management plus placebo comparator
Overall Number of Participants Analyzed 105 113
Least Squares Mean (Standard Error)
Unit of Measure: percentage heavy drinking days
16.5  (2.56) 18.8  (2.44)
6.Secondary Outcome
Title Percent Subjects Abstinent
Hide Description Timeline Follow Back data used to calculate the % of subjects that maintained abstinence weeks 3-11.
Time Frame Study Weeks 3-11
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Quetiapine Fumerate Plus Medical Management Sugar Pill Plus Medical Management
Hide Arm/Group Description:
Quetiapine fumarate - target dose 400mg/day plus medical management
Medical management plus placebo comparator
Overall Number of Participants Analyzed 105 113
Measure Type: Count of Participants
Unit of Measure: Participants
12
  11.4%
12
  10.6%
7.Secondary Outcome
Title Percent Subjects With no Heavy Drinking Day
Hide Description Timeline Follow Back data used to calculate the % of subjects that didn't have a heavy drinking day during study weeks 3-11.
Time Frame Study Weeks 3-11
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Quetiapine Fumerate Plus Medical Management Sugar Pill Plus Medical Management
Hide Arm/Group Description:
Quetiapine fumarate - target dose 400mg/day plus medical management
Medical management plus placebo comparator
Overall Number of Participants Analyzed 105 113
Measure Type: Count of Participants
Unit of Measure: Participants
17
  16.2%
24
  21.2%
8.Secondary Outcome
Title Drinking Consequences Score
Hide Description Drinkers Inventory of Consequences (DrInC) - Alcohol-related problems are determined using the DrInC (Miller et al., 1995). The DrInC is a self-administered 50-item questionnaire designed to measure adverse consequences of alcohol abuse in five areas: Interpersonal, Physical, Social, Impulsive, and Intrapersonal. Each scale provides a lifetime and past 3-month measure of adverse consequences, and scales can be combined to assess total adverse consequences. We used a modified version of the DrInC that just included the 45-items that summed the Interpersonal, Physical, Social, and Impulsivity items. This total score (min=0, max=135) was analyzed in this study with high scores indicative of more alcohol-related consequences (a poor outcome for a given study participant). The DrInC was assessed at study weeks 6 and 12. Analyses averaged across these weeks.
Time Frame Weeks 6 & 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Quetiapine Fumerate Plus Medical Management Sugar Pill Plus Medical Management
Hide Arm/Group Description:
Quetiapine fumarate - target dose 400mg/day plus medical management
Medical management plus placebo comparator
Overall Number of Participants Analyzed 105 113
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
18.5  (1.87) 22.5  (1.78)
9.Secondary Outcome
Title Penn Alcohol Craving Score (PACS_
Hide Description The Penn Alcohol Craving Scale (PACS) is a five-item, self-report measure that includes questions about the frequency, intensity, and duration of craving, the ability to resist drinking, and asks for an overall rating of craving for alcohol for the previous week (Flannery et al., 1999). The summed total score of the 5 items was used in the analysis (min=0, max=30) with higher scores indicative of higher craving for alcohol (a poor outcome). Based on clinical study results, the PACS has been shown to be a reliable and valid measure of alcohol craving and can predict subjects at risk for subsequent relapse. The PACS was assessed at study weeks 4, 6, 8, 10, and 12. Analyses averaged across these weeks.
Time Frame Weeks 4, 6, 8, 10, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Quetiapine Fumerate Plus Medical Management Sugar Pill Plus Medical Management
Hide Arm/Group Description:
Quetiapine fumarate - target dose 400mg/day plus medical management
Medical management plus placebo comparator
Overall Number of Participants Analyzed 105 113
Mean (Standard Error)
Unit of Measure: score on a scale
12.1  (0.63) 12.8  (0.60)
10.Secondary Outcome
Title Montgomery-Asberg Depression Rating Scale (MADRS)
Hide Description The MADRS is an observer rating scale that has proven to be an efficient and practical measure of depression (Montgomery and Asberg, 1979). The scale was constructed to be sensitive to changes in treatment effects. Its capacity to differentiate between responders and non-responders to antidepressant treatment has been shown to be comparable to the Hamilton Rating Scale for Depression, another established measure of depressive symptomatology, but the MADRS has greater sensitivity to change during the course of a depressive phase. It has exhibited high inter-rater reliability and appears to be oriented more towards psychic as opposed to somatic aspects of depression. The MADRS is the sum of the 10-item in a checklist where items are rated on a scale of 0 to 6 with anchors at 2-point intervals. Scores range from 0 to 60. Higher scores are indicative of greater depressive symptoms (a poor outcome). The MADRS was assessed at weeks 4, 6, 8, 10, and 12. Analyses averaged across these weeks.
Time Frame Weeks 3-11
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Quetiapine Fumerate Plus Medical Management Sugar Pill Plus Medical Management
Hide Arm/Group Description:
Quetiapine fumarate - target dose 400mg/day plus medical management
Medical management plus placebo comparator
Overall Number of Participants Analyzed 105 113
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
2.8  (0.39) 4.1  (0.37)
11.Secondary Outcome
Title Hamilton Anxiety Scale (HAM-A)
Hide Description The Hamilton Anxiety Scale consists of 14 items, each defined by a series of symptoms. Similar to the HAM-D, each item is rated on a 5-point scale, ranging from 0 (not present) to 4 (severe) (Guy, 1976). A total score is derived from the summed items (min=0, max=56) with higher scores indicative of greater anxiety (a poor outcome). The HAM-A was assessed at study weeks 4, 6, 8, 10, and 12. Analyses averaged across these weeks.
Time Frame Weeks 4, 6, 8, 10, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Quetiapine Fumerate Plus Medical Management Sugar Pill Plus Medical Management
Hide Arm/Group Description:
Quetiapine fumarate - target dose 400mg/day plus medical management
Medical management plus placebo comparator
Overall Number of Participants Analyzed 105 113
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
2.4  (0.26) 3.0  (.24)
12.Secondary Outcome
Title Pittsburgh Sleep Quality Score
Hide Description The PSQI is a 19-item questionnaire assessing the subject's overall sleep experience in the past 30 days (Buysse et al-1989). The lower the overall score, the better the person sleeps. The tool has an adequate internal reliability, validity and consistency for clinical and community samples of the various populations. Range is (0-21); >6 indicative of "poor" sleep quality. The PSQI was assessed at study weeks 4,8, and 12. Analyses averaged across these weeks.
Time Frame Weeks 4, 8, 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Quetiapine Fumerate Plus Medical Management Sugar Pill Plus Medical Management
Hide Arm/Group Description:
Quetiapine fumarate - target dose 400mg/day plus medical management
Medical management plus placebo comparator
Overall Number of Participants Analyzed 105 113
Least Squares Mean (Standard Error)
Unit of Measure: score
4.1  (0.27) 5.1  (0.26)
13.Secondary Outcome
Title Quality of Life SF - 12 - Mental Aggregate Score
Hide Description The SF-12 will be used to assess overall health status. The SF-12 is a 12-item questionnaire developed in 1994 as a shorter alternative to the SF-36 to reproduce the physical and mental health summary measures with at least 90% accuracy. We calculated the physical and mental component summary scores which were both converted to T-scores (min=0, max=100) normed to the general population such that a T=50 is the average score in the general population. Higher scores are indicative of better health status.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Quetiapine Fumerate Plus Medical Management Sugar Pill Plus Medical Management
Hide Arm/Group Description:
Quetiapine fumarate - target dose 400mg/day plus medical management
Medical management plus placebo comparator
Overall Number of Participants Analyzed 105 113
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
51.5  (1.12) 50.7  (1.08)
14.Secondary Outcome
Title Quality of Life SF-12 - Physical Aggregate Score
Hide Description The SF-12 will be used to assess overall health status. The SF-12 is a 12-item questionnaire developed in 1994 as a shorter alternative to the SF-36 to reproduce the physical and mental health summary measures with at least 90% accuracy. We calculated the physical and mental component summary scores which were both converted to T-scores (min=0, max=100) normed to the general population such that a T=50 is the average score in the general population. Higher scores are indicative of better health status.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
mITT
Arm/Group Title Quetiapine Placebo
Hide Arm/Group Description:

Quetiapine fumarate plus medical management

Quetiapine fumarate: Quetiapine fumarate- taken daily, for 12 weeks

Medical management plus placebo comparator

Placebo: Placebo

Overall Number of Participants Analyzed 105 113
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
51.0  (0.82) 50.6  (0.93)
Time Frame [Not Specified]
Adverse Event Reporting Description Systematic assessment at each clinic visit and telephone contact in response to the question "How have you been feeling since the last time we spoke?"
 
Arm/Group Title Quetiapine Fumerate Plus Medical Management Sugar Pill Plus Medical Management
Hide Arm/Group Description Quetiapine fumarate - target dose 400mg/day plus medical management Medical management plus placebo comparator
All-Cause Mortality
Quetiapine Fumerate Plus Medical Management Sugar Pill Plus Medical Management
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Quetiapine Fumerate Plus Medical Management Sugar Pill Plus Medical Management
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/105 (5.71%)      5/113 (4.42%)    
Blood and lymphatic system disorders     
Ruptured Spleen  1  1/105 (0.95%)  1 0/113 (0.00%)  0
Cardiac disorders     
Pre-ventricular contractions  1  0/105 (0.00%)  0 1/113 (0.88%)  1
Injury, poisoning and procedural complications     
Automobile Accident  1  1/105 (0.95%)  1 0/113 (0.00%)  0
Psychiatric disorders     
Alcohol Detoxification  1  3/105 (2.86%)  4 3/113 (2.65%)  3
Behavioral Disturbance while intoxicated  1  0/105 (0.00%)  0 1/113 (0.88%)  1
Suicidal Ideation   1/105 (0.95%)  1 0/113 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Quetiapine Fumerate Plus Medical Management Sugar Pill Plus Medical Management
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   105/105 (100.00%)      110/113 (97.35%)    
Gastrointestinal disorders     
Dry Mouth   34/105 (32.38%)  36 10/113 (8.85%)  11
Dyspepsia   14/105 (13.33%)  22 2/113 (1.77%)  2
Nausea  1  10/105 (9.52%)  11 20/113 (17.70%)  25
Vomiting  1  15/105 (14.29%)  20 14/113 (12.39%)  15
Constipation  1  8/105 (7.62%)  10 8/113 (7.08%)  11
Diarrhoea  1  6/105 (5.71%)  7 11/113 (9.73%)  12
General disorders     
Fatigue  1  22/105 (20.95%)  29 17/113 (15.04%)  18
Feeling Abnormal  1  10/105 (9.52%)  11 8/113 (7.08%)  8
Irritability  1  8/105 (7.62%)  8 7/113 (6.19%)  9
Pain  1  6/105 (5.71%)  6 9/113 (7.96%)  9
Infections and infestations     
Upper Respiratory Tract Infection  1  4/105 (3.81%)  4 12/113 (10.62%)  12
Investigations     
Weight Increased  1  20/105 (19.05%)  21 12/113 (10.62%)  13
Blood Glucose Increased  1  3/105 (2.86%)  3 8/113 (7.08%)  9
Metabolism and nutrition disorders     
Increased Appetite   12/105 (11.43%)  12 1/113 (0.88%)  1
Musculoskeletal and connective tissue disorders     
Back Pain  1  8/105 (7.62%)  10 15/113 (13.27%)  22
Arthralgia  1  9/105 (8.57%)  12 5/113 (4.42%)  6
Mylagia  1  6/105 (5.71%)  6 4/113 (3.54%)  4
Nervous system disorders     
Dizziness   15/105 (14.29%)  20 5/113 (4.42%)  6
Sedation   16/105 (15.24%)  18 3/113 (2.65%)  3
Somnelence   36/105 (34.29%)  42 10/113 (8.85%)  10
Headache  1  36/105 (34.29%)  60 49/113 (43.36%)  83
Tremor  1  16/105 (15.24%)  19 14/113 (12.39%)  18
Psychiatric disorders     
Anxiety  1  20/105 (19.05%)  26 25/113 (22.12%)  33
Insomnia  1  14/105 (13.33%)  15 24/113 (21.24%)  26
Depressed Mood  1  7/105 (6.67%)  8 10/113 (8.85%)  13
Abnormal Dreams  1  10/105 (9.52%)  10 8/113 (7.08%)  10
Agitation  1  10/105 (9.52%)  11 6/113 (5.31%)  8
Respiratory, thoracic and mediastinal disorders     
Nasal Congestion  1  11/105 (10.48%)  14 11/113 (9.73%)  13
Cough  1  8/105 (7.62%)  10 13/113 (11.50%)  14
Oropharynageal Pain  1  9/105 (8.57%)  10 6/113 (5.31%)  7
Skin and subcutaneous tissue disorders     
Hyperhidrosis  1  7/105 (6.67%)  7 7/113 (6.19%)  7
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
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. Raye Litten
Organization: NIAAA
Phone: 301-443-0636
Layout table for additonal information
Responsible Party: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
ClinicalTrials.gov Identifier: NCT00498628     History of Changes
Other Study ID Numbers: NIAAA_DTRR-2007-LITTEN-01
First Submitted: July 6, 2007
First Posted: July 10, 2007
Results First Submitted: April 25, 2012
Results First Posted: May 30, 2012
Last Update Posted: March 19, 2019