Clinical trial NCT00457197: Quetiapine for Bipolar Disorder and Alcohol Dependence
Official title: Quetiapine for Bipolar Disorder and Alcohol Dependence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bipolar Disorder
Alcohol Dependence
Keywords: bipolar disorder
alcohol dependence
mania
manic disorder
depression
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2007-04-06
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Outpatients with a diagnosis of bipolar I or II disorder, depressed or mixed phase on the Structured Clinical Interview for the Diagnostic and Statistical Manual for Mental Disorders (SCID) and confirmed by interview with PI or co-I.
* Current diagnosis of alcohol dependence.
* Alcohol use (by self-report) of at least 15 drinks in the 7 days prior to baseline.
* Currently taking a mood stabilizer defined as lithium, divalproex/valproic acid, oxcarbazepine, or lamotrigine at a stable dose for \> 14 days.
* Men and women age 18-65 years old.
* English or Spanish speaking.

Exclusion Criteria:

* Bipolar disorders other than bipolar I or II (e.g., not otherwise specified or cyclothymic disorders) based on the SCID and confirmed through clinical assessment by PI or co-I.
* Baseline Young Mania Rating Scale (YMRS) score \> 35 or Hamilton Depression Rating Scale (HRSD) 17 score \> 35.
* Current clinically significant psychotic features (hallucinations, delusions, disorganized thought processes).
* Evidence of clinically significant alcohol withdrawal symptoms defined as a Clinical Institute Withdrawal Assessment (CIWA-AR) score of \> 8.
* History of hepatic cirrhosis or baseline AST or ALT \> 3X upper limit of normal or other clinically significant findings on physical or laboratory examination.
* Mental retardation or other severe cognitive impairment.
* Prison or jail inmates.
* Pregnant or nursing women or women of childbearing age who will not use oral contraceptives, abstinence, or other acceptable methods of birth control during the study.
* Antipsychotic therapy within 14 days prior to randomization.
* Current carbamazepine or benzodiazepine therapy.
* Current treatment with medications shown to reduce alcohol consumption (naltrexone, acamprosate, disulfiram, or topiramate) in large randomized, controlled trials.
* Initiation of antidepressants or mood stabilizers or psychotherapy within past 2 weeks.
* High risk for suicide, defined as any suicide attempts in the past 3 months or current suicidal ideation with plan and intent.
* Intensive outpatient treatment for substance abuse (AA, NA meetings, or other 12-step programs or weekly psychotherapy that started at least 14 days prior to randomization will be allowed).
* Current treatment with ketoconazole, itraconazole, erythromycin, or nefazodone.
* Severe or life-threatening medical condition (e.g., congestive heart failure, terminal cancer) or laboratory or physical examination findings consistent with serious medical illness (e.g., severe edema, atrial fibrillation, dangerously abnormal electrolytes).
* Diabetes mellitus by history or suspected from baseline blood sugar.
* History of cataracts or suspected cataracts on ophthalmic exam
* History of seizure disorder of any etiology; if a subject develops a seizure episode, s/he will be discontinued from the study.

Primary outcomes:
measure: The Number of Standard Drinks/Day Will Serve as the Primary Outcome Measure.
timeFrame: 12 weeks
Secondary outcomes:
measure: Percent of Heavy Drinking Days
timeFrame: 12 weeks
measure: Gamma-glutamyltransferase (GGT)
timeFrame: 12 weeks
measure: Aspartate Aminotransferase (AST)
timeFrame: 12 weeks
measure: Alanine Aminotransferase (ALT)
timeFrame: 12 weeks
measure: Hamilton Rating Scale for Depression (HRSD)
timeFrame: 12 weeks
measure: Inventory of Depressive Symptomatology-Self Report (IDS-SR)
timeFrame: 12 weeks
measure: Young Mania Rating Scale (YMRS)
timeFrame: 12 weeks
measure: Penn Alcohol Craving Scale (PACS)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Psychoneuroendocrine Research Program
state: Texas
Study officials:
affiliation: UT Southwestern Medical Center
name: E. Sherwood Brown, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: