Quetiapine for Bipolar Disorder and Alcohol Dependence
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- The Number of Standard Drinks/Day Will Serve as the Primary Outcome Measure.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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 >
- •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 >
- •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.
研究组 & 干预措施
Placebo
This group will be given placebo matching quetiapine for the course of the 12 weeks in the study.
干预措施: Placebo (Drug)
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.
干预措施: Quetiapine (Drug)
结局指标
主要结局
The Number of Standard Drinks/Day Will Serve as the Primary Outcome Measure.
时间窗: 12 weeks
次要结局
- Percent of Heavy Drinking Days(12 weeks)
- Gamma-glutamyltransferase (GGT)(12 weeks)
- Aspartate Aminotransferase (AST)(12 weeks)
- Alanine Aminotransferase (ALT)(12 weeks)
- Hamilton Rating Scale for Depression (HRSD)(12 weeks)
- Inventory of Depressive Symptomatology-Self Report (IDS-SR)(12 weeks)
- Young Mania Rating Scale (YMRS)(12 weeks)
- Penn Alcohol Craving Scale (PACS)(12 weeks)