Trial Outcomes & Findings for Quetiapine for Bipolar Disorder and Alcohol Dependence (NCT NCT00457197)
NCT ID: NCT00457197
Last Updated: 2025-07-25
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
90 participants
Primary outcome timeframe
12 weeks
Results posted on
2025-07-25
Participant Flow
Participant milestones
| Measure |
Placebo
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.
|
Quetiapine
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 Study
STARTED
|
45
|
45
|
|
Overall Study
COMPLETED
|
44
|
44
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Quetiapine for Bipolar Disorder and Alcohol Dependence
Baseline characteristics by cohort
| Measure |
Placebo
n=44 Participants
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.
|
Quetiapine
n=44 Participants
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
n=88 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
39.7 years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
43.3 years
STANDARD_DEVIATION 8.2 • n=7 Participants
|
41.5 years
STANDARD_DEVIATION 9.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
21 participants
n=5 Participants
|
21 participants
n=7 Participants
|
42 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
12 participants
n=5 Participants
|
13 participants
n=7 Participants
|
25 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
10 participants
n=5 Participants
|
7 participants
n=7 Participants
|
17 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Missing
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Married
Married
|
8 participants
n=5 Participants
|
10 participants
n=7 Participants
|
18 participants
n=5 Participants
|
|
Married
Not Married
|
36 participants
n=5 Participants
|
34 participants
n=7 Participants
|
70 participants
n=5 Participants
|
|
History of treatment for drug/alcohol
No History
|
19 participants
n=5 Participants
|
14 participants
n=7 Participants
|
33 participants
n=5 Participants
|
|
% Days Alcohol Use In Past Week
|
74.6 days
STANDARD_DEVIATION 26.1 • n=5 Participants
|
74.2 days
STANDARD_DEVIATION 27.3 • n=7 Participants
|
74.4 days
STANDARD_DEVIATION 26.7 • n=5 Participants
|
|
Education
|
13.3 years
STANDARD_DEVIATION 2.4 • n=5 Participants
|
13.6 years
STANDARD_DEVIATION 2.5 • n=7 Participants
|
13.5 years
STANDARD_DEVIATION 2.5 • n=5 Participants
|
|
Mood states
Depressed
|
40 participants
n=5 Participants
|
38 participants
n=7 Participants
|
78 participants
n=5 Participants
|
|
Mood states
Mixed (both depression and mania at same time)
|
4 participants
n=5 Participants
|
6 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
History of treatment for drug/alcohol
History
|
25 participants
n=5 Participants
|
30 participants
n=7 Participants
|
55 participants
n=5 Participants
|
|
% Days Heavy Alcohol Use In Past Week
|
60.0 Days
STANDARD_DEVIATION 30.1 • n=5 Participants
|
53.0 Days
STANDARD_DEVIATION 30.9 • n=7 Participants
|
56.5 Days
STANDARD_DEVIATION 30.5 • n=5 Participants
|
|
Drinks per day
|
6.5 drinks
STANDARD_DEVIATION 3.4 • n=5 Participants
|
6.0 drinks
STANDARD_DEVIATION 3.4 • n=7 Participants
|
6.3 drinks
STANDARD_DEVIATION 3.4 • n=5 Participants
|
|
Liver enzymes
GGT (gamma-glutamyltransferase
|
47.8 IU/I
STANDARD_DEVIATION 37.6 • n=5 Participants
|
74.3 IU/I
STANDARD_DEVIATION 69.3 • n=7 Participants
|
61.05 IU/I
STANDARD_DEVIATION 53.45 • n=5 Participants
|
|
Liver enzymes
AST (aspartate aminotransferase)
|
27.4 IU/I
STANDARD_DEVIATION 14.8 • n=5 Participants
|
29.7 IU/I
STANDARD_DEVIATION 13.5 • n=7 Participants
|
28.6 IU/I
STANDARD_DEVIATION 14.2 • n=5 Participants
|
|
Liver enzymes
ALT (alanine aminotransferase)
|
29.0 IU/I
STANDARD_DEVIATION 24.5 • n=5 Participants
|
28.9 IU/I
STANDARD_DEVIATION 17.3 • n=7 Participants
|
29.0 IU/I
STANDARD_DEVIATION 20.9 • n=5 Participants
|
|
Concomitant medications
Lithium
|
28 participants
n=5 Participants
|
27 participants
n=7 Participants
|
55 participants
n=5 Participants
|
|
Concomitant medications
No Lithium
|
16 participants
n=5 Participants
|
17 participants
n=7 Participants
|
33 participants
n=5 Participants
|
|
Concomitant medications
Anticonvulsants
|
13 participants
n=5 Participants
|
13 participants
n=7 Participants
|
26 participants
n=5 Participants
|
|
Concomitant medications
No anticonvulsants
|
31 participants
n=5 Participants
|
31 participants
n=7 Participants
|
62 participants
n=5 Participants
|
|
Concomitant medications
Antidepressants
|
6 participants
n=5 Participants
|
11 participants
n=7 Participants
|
17 participants
n=5 Participants
|
|
Concomitant medications
No antidepressants
|
38 participants
n=5 Participants
|
33 participants
n=7 Participants
|
71 participants
n=5 Participants
|
|
Concomitant medications
Sedatives/hypnotics
|
2 participants
n=5 Participants
|
8 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Concomitant medications
No sedatives/hypnotics
|
42 participants
n=5 Participants
|
36 participants
n=7 Participants
|
78 participants
n=5 Participants
|
|
Mood and craving scales: Hamilton Rating Scale for Depression
|
18.3 units on a scale
STANDARD_DEVIATION 6.7 • n=5 Participants
|
18.6 units on a scale
STANDARD_DEVIATION 7.0 • n=7 Participants
|
18.5 units on a scale
STANDARD_DEVIATION 6.9 • n=5 Participants
|
|
Mood and craving scales: Inventory of Depressive Symptomatology-Self-Report
|
28.6 units on a scale
STANDARD_DEVIATION 10.7 • n=5 Participants
|
33.9 units on a scale
STANDARD_DEVIATION 14.6 • n=7 Participants
|
31.3 units on a scale
STANDARD_DEVIATION 12.65 • n=5 Participants
|
|
Mood and craving scales: Young Mania Rating Scale
|
13.6 units on a scale
STANDARD_DEVIATION 8.2 • n=5 Participants
|
13.9 units on a scale
STANDARD_DEVIATION 6.7 • n=7 Participants
|
13.8 units on a scale
STANDARD_DEVIATION 7.5 • n=5 Participants
|
|
Mood and craving scales: Penn Alcohol Craving Scale
|
19.2 units on a scale
STANDARD_DEVIATION 6.6 • n=5 Participants
|
20.6 units on a scale
STANDARD_DEVIATION 6.3 • n=7 Participants
|
19.9 units on a scale
STANDARD_DEVIATION 6.5 • n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksOutcome measures
| Measure |
Placebo
n=44 Participants
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.
|
Quetiapine
n=44 Participants
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.
|
|---|---|---|
|
The Number of Standard Drinks/Day Will Serve as the Primary Outcome Measure.
|
10.6 drinks
Standard Error 2.465
|
8.09 drinks
Standard Error 2.465
|
SECONDARY outcome
Timeframe: 12 weeksOutcome measures
| Measure |
Placebo
n=44 Participants
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.
|
Quetiapine
n=44 Participants
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.
|
|---|---|---|
|
Percent of Heavy Drinking Days
|
28.8 drinks
Standard Error 3.66
|
20.8 drinks
Standard Error 3.66
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Missing data for 18 participants in placebo group and 11 participants in the quetiapine group.
GGT is a liver enzyme measurement (IU/I)
Outcome measures
| Measure |
Placebo
n=26 Participants
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.
|
Quetiapine
n=33 Participants
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.
|
|---|---|---|
|
Gamma-glutamyltransferase (GGT)
|
66.6 IU/I
Standard Error 8.34
|
66.0 IU/I
Standard Error 7.38
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Missing data for 19 participants in placebo group and 11 participants in the quetiapine group.
AST is a liver enzyme measurement (IU/I)
Outcome measures
| Measure |
Placebo
n=25 Participants
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.
|
Quetiapine
n=33 Participants
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.
|
|---|---|---|
|
Aspartate Aminotransferase (AST)
|
29.7 IU/I
Standard Error 2.92
|
31.1 IU/I
Standard Error 2.54
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Missing data for 17 participants in placebo group and 13 participants in the quetiapine group.
ALT is a liver enzyme measurement (IU/I).
Outcome measures
| Measure |
Placebo
n=27 Participants
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.
|
Quetiapine
n=31 Participants
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.
|
|---|---|---|
|
Alanine Aminotransferase (ALT)
|
25.1 IU/I
Standard Error 2.61
|
30.4 IU/I
Standard Error 2.43
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Missing data for 2 participants in placebo group and 3 participants in the quetiapine group.
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
Outcome measures
| Measure |
Placebo
n=42 Participants
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.
|
Quetiapine
n=41 Participants
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.
|
|---|---|---|
|
Hamilton Rating Scale for Depression (HRSD)
|
10.9 units on a scale
Standard Error 1.10
|
10.3 units on a scale
Standard Error 1.12
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Missing data for 4 participants in placebo group and 2 participants in the quetiapine group.
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
Outcome measures
| Measure |
Placebo
n=40 Participants
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.
|
Quetiapine
n=42 Participants
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.
|
|---|---|---|
|
Inventory of Depressive Symptomatology-Self Report (IDS-SR)
|
19.0 units on a scale
Standard Error 1.79
|
21.9 units on a scale
Standard Error 1.75
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Missing data for 6 participants in placebo group and 1 participant in the quetiapine group.
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
Outcome measures
| Measure |
Placebo
n=38 Participants
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.
|
Quetiapine
n=43 Participants
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.
|
|---|---|---|
|
Young Mania Rating Scale (YMRS)
|
8.70 units on a scale
Standard Error 1.09
|
8.48 units on a scale
Standard Error 1.02
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Missing data for 1 participants in placebo group and 5 participants in the quetiapine group.
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.
Outcome measures
| Measure |
Placebo
n=43 Participants
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.
|
Quetiapine
n=39 Participants
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.
|
|---|---|---|
|
Penn Alcohol Craving Scale (PACS)
|
14.1 units on a scale
Standard Error 1.03
|
12.3 units on a scale
Standard Error 1.09
|
Adverse Events
Placebo
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Quetiapine
Serious events: 5 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=45 participants at risk
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.
|
Quetiapine
n=45 participants at risk
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.
|
|---|---|---|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/45
|
2.2%
1/45
|
|
Injury, poisoning and procedural complications
Fall
|
4.4%
2/45
|
0.00%
0/45
|
|
Injury, poisoning and procedural complications
Victim of Sexual Assault
|
0.00%
0/45
|
2.2%
1/45
|
|
Psychiatric disorders
Arrest for Public Intoxication
|
2.2%
1/45
|
2.2%
1/45
|
|
Psychiatric disorders
Panic Attack
|
0.00%
0/45
|
2.2%
1/45
|
|
Respiratory, thoracic and mediastinal disorders
Asthma Exacerbation
|
0.00%
0/45
|
2.2%
1/45
|
Other adverse events
Adverse event data not reported
Additional Information
E. Sherwood Brown, M.D., Ph.D., Professor
The University of Texas Southwestern Medical Center
Phone: 214-645-6950
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place