Quetiapine for Bipolar Disorder and Alcohol Dependence
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|ClinicalTrials.gov Identifier: NCT00457197|
Recruitment Status : Completed
First Posted : April 6, 2007
Results First Posted : January 28, 2016
Last Update Posted : April 5, 2016
|Condition or disease||Intervention/treatment||Phase|
|Bipolar Disorder Alcohol Dependence||Drug: Placebo Drug: Quetiapine||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Quetiapine for Bipolar Disorder and Alcohol Dependence|
|Study Start Date :||March 2007|
|Actual Primary Completion Date :||July 2011|
|Actual Study Completion Date :||July 2011|
Placebo Comparator: Placebo
This group will be given placebo matching quetiapine for the course of the 12 weeks in the study.
Inactive ingredient matching the active medication in appearance.
Other Name: Sugar-pill
Active Comparator: 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 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. [ Time Frame: 12 weeks ]
- Percent of Heavy Drinking Days [ Time Frame: 12 weeks ]
- Gamma-glutamyltransferase (GGT) [ Time Frame: 12 weeks ]GGT is a liver enzyme measurement (IU/I)
- Aspartate Aminotransferase (AST) [ Time Frame: 12 weeks ]AST is a liver enzyme measurement (IU/I)
- Alanine Aminotransferase (ALT) [ Time Frame: 12 weeks ]ALT is a liver enzyme measurement (IU/I).
- Hamilton Rating Scale for Depression (HRSD) [ Time Frame: 12 weeks ]
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+).
Minimum: 0 Maximum: 50 Lower score associated with better outcome
- Inventory of Depressive Symptomatology-Self Report (IDS-SR) [ Time Frame: 12 weeks ]
IDS-SR is a self reported 30 item assessment to diagnose a major depressive episode.
Minimum: 0 Maximum: 84 Lower score associated with better outcome
- Young Mania Rating Scale (YMRS) [ Time Frame: 12 weeks ]
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).
Minimum: 0 Maximum: 60 Lower score associated with better outcome
- Penn Alcohol Craving Scale (PACS) [ Time Frame: 12 weeks ]
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
Minimum: 0 Maximum: 30 Lower score associated with better outcome.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00457197
|United States, Texas|
|Psychoneuroendocrine Research Program|
|Dallas, Texas, United States, 75235|
|Principal Investigator:||E. Sherwood Brown, MD PhD||UT Southwestern Medical Center|