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Trial record 72 of 450 for:    QUETIAPINE

Quetiapine for Bipolar Disorder and Alcohol Dependence

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: NCT00457197
Recruitment Status : Completed
First Posted : April 6, 2007
Results First Posted : January 28, 2016
Last Update Posted : April 5, 2016
Sponsor:
Information provided by (Responsible Party):
University of Texas Southwestern 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 Bipolar Disorder
Alcohol Dependence
Interventions Drug: Placebo
Drug: Quetiapine
Enrollment 90
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Quetiapine
Hide Arm/Group Description

This group will be given placebo matching quetiapine for the course of the 12 weeks in the study.

Placebo: Inactive ingredient matching the active medication in appearance.

This group will be given 50mg Quetiapine per day baseline-week 1, 100mg Quetiapine per day week 1-week 2, 200mg Quetiapine per day week 2-week 3, 400mg Quetiapine per day week 3-week 4, and 600mg Quetiapine per day week 4 to week 12.

Quetiapine: Quetiapine is an atypical antipsychotic approved for the treatment of schizophrenia, bipolar disorder, and in the XR version along with an SSRI to treat major depressive disorder.

Period Title: Overall Study
Started 45 45
Completed 44 44
Not Completed 1 1
Arm/Group Title Placebo Quetiapine Total
Hide Arm/Group Description

This group will be given placebo matching quetiapine for the course of the 12 weeks in the study.

Placebo: Inactive ingredient matching the active medication in appearance.

This group will be given 50mg Quetiapine per day baseline-week 1, 100mg Quetiapine per day week 1-week 2, 200mg Quetiapine per day week 2-week 3, 400mg Quetiapine per day week 3-week 4, and 600mg Quetiapine per day week 4 to week 12.

Quetiapine: Quetiapine is an atypical antipsychotic approved for the treatment of schizophrenia, bipolar disorder, and in the XR version along with an SSRI to treat major depressive disorder.

Total of all reporting groups
Overall Number of Baseline Participants 44 44 88
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 44 participants 44 participants 88 participants
39.7  (10.1) 43.3  (8.2) 41.5  (9.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants 44 participants 88 participants
Female
19
  43.2%
17
  38.6%
36
  40.9%
Male
25
  56.8%
27
  61.4%
52
  59.1%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 44 participants 44 participants 88 participants
Caucasian 21 21 42
African American 12 13 25
Hispanic 10 7 17
Other 1 2 3
Missing 0 1 1
Married  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 44 participants 44 participants 88 participants
Married 8 10 18
Not Married 36 34 70
Education  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 44 participants 44 participants 88 participants
13.3  (2.4) 13.6  (2.5) 13.5  (2.5)
Mood states  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 44 participants 44 participants 88 participants
Depressed 40 38 78
Mixed (both depression and mania at same time) 4 6 10
History of treatment for drug/alcohol  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 44 participants 44 participants 88 participants
History 25 30 55
No History 19 14 33
% Days Alcohol Use In Past Week  
Mean (Standard Deviation)
Unit of measure:  Days
Number Analyzed 44 participants 44 participants 88 participants
74.6  (26.1) 74.2  (27.3) 74.4  (26.7)
% Days Heavy Alcohol Use In Past Week  
Mean (Standard Deviation)
Unit of measure:  Days
Number Analyzed 44 participants 44 participants 88 participants
60.0  (30.1) 53.0  (30.9) 56.5  (30.5)
Drinks per day  
Mean (Standard Deviation)
Unit of measure:  Drinks
Number Analyzed 44 participants 44 participants 88 participants
6.5  (3.4) 6.0  (3.4) 6.3  (3.4)
Liver enzymes  
Mean (Standard Deviation)
Unit of measure:  IU/I
Number Analyzed 44 participants 44 participants 88 participants
GGT (gamma-glutamyltransferase 47.8  (37.6) 74.3  (69.3) 61.05  (53.45)
AST (aspartate aminotransferase) 27.4  (14.8) 29.7  (13.5) 28.6  (14.2)
ALT (alanine aminotransferase) 29.0  (24.5) 28.9  (17.3) 29.0  (20.9)
Concomitant medications  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 44 participants 44 participants 88 participants
Lithium 28 27 55
No Lithium 16 17 33
Concomitant medications  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 44 participants 44 participants 88 participants
Anticonvulsants 13 13 26
No anticonvulsants 31 31 62
Concomitant medications  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 44 participants 44 participants 88 participants
Antidepressants 6 11 17
No antidepressants 38 33 71
Concomitant medications  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 44 participants 44 participants 88 participants
Sedatives/hypnotics 2 8 10
No sedatives/hypnotics 42 36 78
Mood and craving scales: Hamilton Rating Scale for Depression   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 44 participants 44 participants 88 participants
18.3  (6.7) 18.6  (7.0) 18.5  (6.9)
[1]
Measure Description: Minimum: 0 Maximum: 50 Lower score associated with better outcome Normal= 7 or less
Mood and craving scales: Inventory of Depressive Symptomatology-Self-Report   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 44 participants 44 participants 88 participants
28.6  (10.7) 33.9  (14.6) 31.3  (12.65)
[1]
Measure Description: Minimum= 0 Maximum= 84 Lower score associated with better outcome Normal= 7 or less
Mood and craving scales: Young Mania Rating Scale   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 44 participants 44 participants 88 participants
13.6  (8.2) 13.9  (6.7) 13.8  (7.5)
[1]
Measure Description: Minimum: 0 Maximum: 60 Lower score associated with better outcome
Mood and craving scales: Penn Alcohol Craving Scale   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 44 participants 44 participants 88 participants
19.2  (6.6) 20.6  (6.3) 19.9  (6.5)
[1]
Measure Description: Minimum: 0 Maximum: 30 Lower score associated with better outcome
1.Primary Outcome
Title The Number of Standard Drinks/Day Will Serve as the Primary Outcome Measure.
Hide Description [Not Specified]
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Quetiapine
Hide Arm/Group Description:

This group will be given placebo matching quetiapine for the course of the 12 weeks in the study.

Placebo: Inactive ingredient matching the active medication in appearance.

This group will be given 50mg Quetiapine per day baseline-week 1, 100mg Quetiapine per day week 1-week 2, 200mg Quetiapine per day week 2-week 3, 400mg Quetiapine per day week 3-week 4, and 600mg Quetiapine per day week 4 to week 12.

Quetiapine: Quetiapine is an atypical antipsychotic approved for the treatment of schizophrenia, bipolar disorder, and in the XR version along with an SSRI to treat major depressive disorder.

Overall Number of Participants Analyzed 44 44
Least Squares Mean (Standard Error)
Unit of Measure: drinks
10.6  (2.465) 8.09  (2.465)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Quetiapine
Comments Baseline drinks/day used as covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4709
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
2.Secondary Outcome
Title Percent of Heavy Drinking Days
Hide Description [Not Specified]
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Quetiapine
Hide Arm/Group Description:

This group will be given placebo matching quetiapine for the course of the 12 weeks in the study.

Placebo: Inactive ingredient matching the active medication in appearance.

This group will be given 50mg Quetiapine per day baseline-week 1, 100mg Quetiapine per day week 1-week 2, 200mg Quetiapine per day week 2-week 3, 400mg Quetiapine per day week 3-week 4, and 600mg Quetiapine per day week 4 to week 12.

Quetiapine: Quetiapine is an atypical antipsychotic approved for the treatment of schizophrenia, bipolar disorder, and in the XR version along with an SSRI to treat major depressive disorder.

Overall Number of Participants Analyzed 44 44
Least Squares Mean (Standard Error)
Unit of Measure: drinks
28.8  (3.66) 20.8  (3.66)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Quetiapine
Comments Baseline percent heavy drinking days included as covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1272
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
3.Secondary Outcome
Title Gamma-glutamyltransferase (GGT)
Hide Description GGT is a liver enzyme measurement (IU/I)
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Missing data for 18 participants in placebo group and 11 participants in the quetiapine group.
Arm/Group Title Placebo Quetiapine
Hide Arm/Group Description:

This group will be given placebo matching quetiapine for the course of the 12 weeks in the study.

Placebo: Inactive ingredient matching the active medication in appearance.

This group will be given 50mg Quetiapine per day baseline-week 1, 100mg Quetiapine per day week 1-week 2, 200mg Quetiapine per day week 2-week 3, 400mg Quetiapine per day week 3-week 4, and 600mg Quetiapine per day week 4 to week 12.

Quetiapine: Quetiapine is an atypical antipsychotic approved for the treatment of schizophrenia, bipolar disorder, and in the XR version along with an SSRI to treat major depressive disorder.

Overall Number of Participants Analyzed 26 33
Least Squares Mean (Standard Error)
Unit of Measure: IU/I
66.6  (8.34) 66.0  (7.38)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Quetiapine
Comments Baseline GGT used as covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9642
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
4.Secondary Outcome
Title Aspartate Aminotransferase (AST)
Hide Description AST is a liver enzyme measurement (IU/I)
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Missing data for 19 participants in placebo group and 11 participants in the quetiapine group.
Arm/Group Title Placebo Quetiapine
Hide Arm/Group Description:

This group will be given placebo matching quetiapine for the course of the 12 weeks in the study.

Placebo: Inactive ingredient matching the active medication in appearance.

This group will be given 50mg Quetiapine per day baseline-week 1, 100mg Quetiapine per day week 1-week 2, 200mg Quetiapine per day week 2-week 3, 400mg Quetiapine per day week 3-week 4, and 600mg Quetiapine per day week 4 to week 12.

Quetiapine: Quetiapine is an atypical antipsychotic approved for the treatment of schizophrenia, bipolar disorder, and in the XR version along with an SSRI to treat major depressive disorder.

Overall Number of Participants Analyzed 25 33
Least Squares Mean (Standard Error)
Unit of Measure: IU/I
29.7  (2.92) 31.1  (2.54)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Quetiapine
Comments Baseline AST used as covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7222
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
5.Secondary Outcome
Title Alanine Aminotransferase (ALT)
Hide Description ALT is a liver enzyme measurement (IU/I).
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Missing data for 17 participants in placebo group and 13 participants in the quetiapine group.
Arm/Group Title Placebo Quetiapine
Hide Arm/Group Description:

This group will be given placebo matching quetiapine for the course of the 12 weeks in the study.

Placebo: Inactive ingredient matching the active medication in appearance.

This group will be given 50mg Quetiapine per day baseline-week 1, 100mg Quetiapine per day week 1-week 2, 200mg Quetiapine per day week 2-week 3, 400mg Quetiapine per day week 3-week 4, and 600mg Quetiapine per day week 4 to week 12.

Quetiapine: Quetiapine is an atypical antipsychotic approved for the treatment of schizophrenia, bipolar disorder, and in the XR version along with an SSRI to treat major depressive disorder.

Overall Number of Participants Analyzed 27 31
Least Squares Mean (Standard Error)
Unit of Measure: IU/I
25.1  (2.61) 30.4  (2.43)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Quetiapine
Comments Baseline ALT used as covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1412
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
6.Secondary Outcome
Title Hamilton Rating Scale for Depression (HRSD)
Hide Description

The assessment is a clinician administered rating of depression with 17 questions. The total score is indicates level of depression within the following ranges: none (0-5), mild (6-10), moderate (11-15), severe (16-20), and very severe (21+).

Scale:

Minimum: 0 Maximum: 50 Lower score associated with better outcome

Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Missing data for 2 participants in placebo group and 3 participants in the quetiapine group.
Arm/Group Title Placebo Quetiapine
Hide Arm/Group Description:

This group will be given placebo matching quetiapine for the course of the 12 weeks in the study.

Placebo: Inactive ingredient matching the active medication in appearance.

This group will be given 50mg Quetiapine per day baseline-week 1, 100mg Quetiapine per day week 1-week 2, 200mg Quetiapine per day week 2-week 3, 400mg Quetiapine per day week 3-week 4, and 600mg Quetiapine per day week 4 to week 12.

Quetiapine: Quetiapine is an atypical antipsychotic approved for the treatment of schizophrenia, bipolar disorder, and in the XR version along with an SSRI to treat major depressive disorder.

Overall Number of Participants Analyzed 42 41
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
10.9  (1.10) 10.3  (1.12)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Quetiapine
Comments Baseline HRSD used as covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7071
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
7.Secondary Outcome
Title Inventory of Depressive Symptomatology-Self Report (IDS-SR)
Hide Description

IDS-SR is a self reported 30 item assessment to diagnose a major depressive episode.

Score:

Minimum: 0 Maximum: 84 Lower score associated with better outcome

Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Missing data for 4 participants in placebo group and 2 participants in the quetiapine group.
Arm/Group Title Placebo Quetiapine
Hide Arm/Group Description:

This group will be given placebo matching quetiapine for the course of the 12 weeks in the study.

Placebo: Inactive ingredient matching the active medication in appearance.

This group will be given 50mg Quetiapine per day baseline-week 1, 100mg Quetiapine per day week 1-week 2, 200mg Quetiapine per day week 2-week 3, 400mg Quetiapine per day week 3-week 4, and 600mg Quetiapine per day week 4 to week 12.

Quetiapine: Quetiapine is an atypical antipsychotic approved for the treatment of schizophrenia, bipolar disorder, and in the XR version along with an SSRI to treat major depressive disorder.

Overall Number of Participants Analyzed 40 42
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
19.0  (1.79) 21.9  (1.75)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Quetiapine
Comments Baseline IDS-SR used as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2569
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
8.Secondary Outcome
Title Young Mania Rating Scale (YMRS)
Hide Description

This is an 11-item, observer rated measure of the severity of manic symptoms on a 5 point scale. The total score indicates overall severity of mania with a minimum of zero (indicating normalcy) and a maximum of 60 (indicating very severe).

Score:

Minimum: 0 Maximum: 60 Lower score associated with better outcome

Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Missing data for 6 participants in placebo group and 1 participant in the quetiapine group.
Arm/Group Title Placebo Quetiapine
Hide Arm/Group Description:

This group will be given placebo matching quetiapine for the course of the 12 weeks in the study.

Placebo: Inactive ingredient matching the active medication in appearance.

This group will be given 50mg Quetiapine per day baseline-week 1, 100mg Quetiapine per day week 1-week 2, 200mg Quetiapine per day week 2-week 3, 400mg Quetiapine per day week 3-week 4, and 600mg Quetiapine per day week 4 to week 12.

Quetiapine: Quetiapine is an atypical antipsychotic approved for the treatment of schizophrenia, bipolar disorder, and in the XR version along with an SSRI to treat major depressive disorder.

Overall Number of Participants Analyzed 38 43
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
8.70  (1.09) 8.48  (1.02)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Quetiapine
Comments Baseline YMRS used as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8814
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
9.Secondary Outcome
Title Penn Alcohol Craving Scale (PACS)
Hide Description

The PACS is a five-item self-administered instrument for assessing craving, frequency, intensity, and duration of thoughts about drinking are assessed along with ability to resist drinking

Score:

Minimum: 0 Maximum: 30 Lower score associated with better outcome.

Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Missing data for 1 participants in placebo group and 5 participants in the quetiapine group.
Arm/Group Title Placebo Quetiapine
Hide Arm/Group Description:

This group will be given placebo matching quetiapine for the course of the 12 weeks in the study.

Placebo: Inactive ingredient matching the active medication in appearance.

This group will be given 50mg Quetiapine per day baseline-week 1, 100mg Quetiapine per day week 1-week 2, 200mg Quetiapine per day week 2-week 3, 400mg Quetiapine per day week 3-week 4, and 600mg Quetiapine per day week 4 to week 12.

Quetiapine: Quetiapine is an atypical antipsychotic approved for the treatment of schizophrenia, bipolar disorder, and in the XR version along with an SSRI to treat major depressive disorder.

Overall Number of Participants Analyzed 43 39
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
14.1  (1.03) 12.3  (1.09)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Quetiapine
Comments Baseline PACS used as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2473
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Quetiapine
Hide Arm/Group Description

This group will be given placebo matching quetiapine for the course of the 12 weeks in the study.

Placebo: Inactive ingredient matching the active medication in appearance.

This group will be given 50mg Quetiapine per day baseline-week 1, 100mg Quetiapine per day week 1-week 2, 200mg Quetiapine per day week 2-week 3, 400mg Quetiapine per day week 3-week 4, and 600mg Quetiapine per day week 4 to week 12.

Quetiapine: Quetiapine is an atypical antipsychotic approved for the treatment of schizophrenia, bipolar disorder, and in the XR version along with an SSRI to treat major depressive disorder.

All-Cause Mortality
Placebo Quetiapine
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Quetiapine
Affected / at Risk (%) Affected / at Risk (%)
Total   3/45 (6.67%)   5/45 (11.11%) 
Cardiac disorders     
Myocardial Infarction *  0/45 (0.00%)  1/45 (2.22%) 
Injury, poisoning and procedural complications     
Fall *  2/45 (4.44%)  0/45 (0.00%) 
Victim of Sexual Assault *  0/45 (0.00%)  1/45 (2.22%) 
Psychiatric disorders     
Arrest for Public Intoxication *  1/45 (2.22%)  1/45 (2.22%) 
Panic Attack *  0/45 (0.00%)  1/45 (2.22%) 
Respiratory, thoracic and mediastinal disorders     
Asthma Exacerbation *  0/45 (0.00%)  1/45 (2.22%) 
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo Quetiapine
Affected / at Risk (%) Affected / at Risk (%)
Total   0/45 (0.00%)   0/45 (0.00%) 
Larger sample size possibly needed for between-group differences in outcome measures. Pill counts not an optimum measure of medication adherence.
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: E. Sherwood Brown, M.D., Ph.D., Professor
Organization: The University of Texas Southwestern Medical Center
Phone: 214-645-6950
EMail: sherwood.brown@utsouthwestern.edu
Layout table for additonal information
Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT00457197     History of Changes
Other Study ID Numbers: 112006-046
First Submitted: April 4, 2007
First Posted: April 6, 2007
Results First Submitted: October 23, 2015
Results First Posted: January 28, 2016
Last Update Posted: April 5, 2016