The purpose of this study is to find out whether an investigational drug called quetiapine can treat bipolar disorder, improve mood and reduce alcohol use and craving.
The primary aim in the study is to determine if quetiapine treatment is associated with greater reduction in alcohol use than placebo in outpatients with bipolar disorder and alcohol dependence. We will also examine if quetiapine treatment is associated with greater reduction in alcohol craving than placebo in outpatients with bipolar disorder and alcohol dependence and if quetiapine treatment is associated with greater improvement in depressive symptoms than placebo in outpatients with bipolar disorder and alcohol dependence.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
90
Inactive ingredient matching the active medication in appearance.
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.
Psychoneuroendocrine Research Program
Dallas, Texas, United States
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)
GGT is a liver enzyme measurement (IU/I)
Time frame: 12 weeks
Aspartate Aminotransferase (AST)
AST is a liver enzyme measurement (IU/I)
Time frame: 12 weeks
Alanine Aminotransferase (ALT)
ALT is a liver enzyme measurement (IU/I).
Time frame: 12 weeks
Hamilton Rating Scale for Depression (HRSD)
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
Inventory of Depressive Symptomatology-Self Report (IDS-SR)
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
Young Mania Rating Scale (YMRS)
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
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Time frame: 12 weeks
Penn Alcohol Craving Scale (PACS)
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