Quetiapine in Patients With Bipolar and Alcohol Abuse/Dependence
| Status: | Completed |
|---|---|
| Conditions: | Psychiatric, Psychiatric, Bipolar Disorder |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 4/21/2016 |
| Start Date: | November 2002 |
| End Date: | August 2004 |
A Randomized, Double-Blind, Placebo-Controlled Add-On Trial of Quetiapine in Patients With Bipolar Disorder and Alcohol Abuse/ Dependence.
The abuse of alcohol is especially common in people with bipolar disorder. However, very
little is known about the pharmacotherapy of people with both bipolar disorder and alcohol
abuse/dependence. The purpose of this study is to determine if alcohol use and cravings are
decreased with quetiapine add-on therapy compared to placebo and to determine if quetiapine
add-on therapy is associated with greater improvement in mood, impulsivity, functioning and
decreased alcohol use than placebo.
little is known about the pharmacotherapy of people with both bipolar disorder and alcohol
abuse/dependence. The purpose of this study is to determine if alcohol use and cravings are
decreased with quetiapine add-on therapy compared to placebo and to determine if quetiapine
add-on therapy is associated with greater improvement in mood, impulsivity, functioning and
decreased alcohol use than placebo.
Experimental: After obtaining informed consent, 100 patients with bipolar I, or II disorders
and alcohol abuse/dependence confirmed by a structured clinical interview (SCID) will be
enrolled. from referral sources in the community we have developed over the past 3 years. A
medical history and physical examination, including an eye exam with an ophthalmoscope, will
also be performed at baseline to rule out serious medical illnesses and cataracts. Baseline
labs including a liver panel and CBC will be obtained. Women of child-bearing potential will
be given a urine pregnancy test. Baseline measures of psychiatric symptoms will be assessed
with the HRSD, YMRS, and Barratt Impulsiveness Scale. Alcohol cravings will be assessed with
the Obsessive Compulsive Drinking Scale (OCDS). Alcohol use including number of drinks/2
weeks, days used in the past two weeks, and days of heavy use will be obtained as will a
urine drug/alcohol screen. Alcohol use and cravings will also be recorded throughout the
study. Side-effects will be assessed with a general side effects scale, the Abnormal
Involuntary Movement Scale (AIMS), Simpson-Angus Scale (SAS), and Barnes Akathesia Rating
Scale (BARS). GGT levels will also be repeated at weeks 6 and 12. The subjects will be
randomized and receive quetiapine or identical appearing placebo add-on therapy in a
double-blind fashion for 12 weeks. Subjects will return every two weeks for reevaluation
with the above outcome measures and for upward titration of study drug. All subjects will be
given the option of receiving open-label quetiapine for an additional 4 weeks (with
continuing assessment of mood and alcohol use/cravings every 2 weeks) at the end of the
study or discontinuing medication.
and alcohol abuse/dependence confirmed by a structured clinical interview (SCID) will be
enrolled. from referral sources in the community we have developed over the past 3 years. A
medical history and physical examination, including an eye exam with an ophthalmoscope, will
also be performed at baseline to rule out serious medical illnesses and cataracts. Baseline
labs including a liver panel and CBC will be obtained. Women of child-bearing potential will
be given a urine pregnancy test. Baseline measures of psychiatric symptoms will be assessed
with the HRSD, YMRS, and Barratt Impulsiveness Scale. Alcohol cravings will be assessed with
the Obsessive Compulsive Drinking Scale (OCDS). Alcohol use including number of drinks/2
weeks, days used in the past two weeks, and days of heavy use will be obtained as will a
urine drug/alcohol screen. Alcohol use and cravings will also be recorded throughout the
study. Side-effects will be assessed with a general side effects scale, the Abnormal
Involuntary Movement Scale (AIMS), Simpson-Angus Scale (SAS), and Barnes Akathesia Rating
Scale (BARS). GGT levels will also be repeated at weeks 6 and 12. The subjects will be
randomized and receive quetiapine or identical appearing placebo add-on therapy in a
double-blind fashion for 12 weeks. Subjects will return every two weeks for reevaluation
with the above outcome measures and for upward titration of study drug. All subjects will be
given the option of receiving open-label quetiapine for an additional 4 weeks (with
continuing assessment of mood and alcohol use/cravings every 2 weeks) at the end of the
study or discontinuing medication.
Inclusion Criteria:
- Bipolar I or II
- Ages 18-70
Exclusion Criteria:
- Life threatening medical condition causing participation in the study hazardous
- Alcohol abuse within the past 2 weeks
- History of cataracts or likely cataracts on baseline eye exam
- History of hepatic cirrhosis or AST or ALT more than three times normal limit
- Current active suicidal or homicidal ideation
- History of allergic reaction, poor response or intolerable side effects to quetiapine
- Antipsychotic use within 7 days of beginning quetiapine therapy
- Mental retardation, dementia or other severe cognitive impairment
We found this trial at
1
site
Click here to add this to my saved trials
