A Randomized, Double Blind Comparison of Lithium Monotherapy Versus Lithium Plus Divalproex for the Outpatient Management of Hypomania/Mania in Patients With Rapid Cycling Bipolar Disorder Comorbid With Substance Abuse/Dependence
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Time to Treatment for Emerging Symptoms of a Mood Relapse
研究概览
简要总结
This study will determine the efficacy and safety of combination therapy with divalproex and lithium for treating mania in people with rapid cycling bipolar disorder and a substance abuse disorder.
详细描述
Longitudinal Evaluation of the Efficacy and Safety of Divalproex and Lithium in Dual Diagnosis Bipolar Rapid Cycling: This study recruits males and females age 18 and older who currently meet diagnostic criteria for rapid cycling bipolar disorder (type I or II) and who have met the criteria for substance abuse or dependence of cocaine, marijuana and/or alcohol within the past six months. Patients are initially stabilized on dual therapy of lithium and depakote and then randomly assigned to double-blind treatment with either lithium monotherapy or continued dual therapy. Patients remain in the study for six months or until they experience a relapse. Patients in this study are required to bring a friend or family member to all study visits as well as attend chemical dependency services. This study is sponsored by the NIMH. Subjects receive study-related care at no cost.
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
- 16 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •To be included in this study, patients will be required to be either acutely hypomanic or manic as defined by the Diagnostic and Statistical Manual -IV (DSM-IV) and meet criteria for current substance abuse and/or dependence disorder within the last six months.
- •Must have 4 or more episodes in the immediate 12 months prior to study entry.
- •Males or females 16 - 65 years of age.
- •A score of 60 or less on the Global Assessment Scale.
- •Have no medical illness precluding the use of lithium or divalproex.
排除标准
- •Patients who have had intolerable side effects to lithium levels 0.8 meq/L or divalproex levels of 50 ug/ml. Patients who have been completely non-responsive to lithium in the past will be excluded, whereas patients who have had partial responses to lithium will be permitted into the study.
- •Patients with a prior history of seizure disorder, cerebral vascular disease, structural brain damage from trauma, clinically significant focal neurological abnormalities, EEG abnormalities with frank paroxysmal activity or a previous CT/MRI scan of the brain with gross structural abnormalities.
- •Patients who require anticoagulant drug therapy.
- •Patients who have uncontrolled gastrointestinal, renal, hepatic, endocrine, cardiovascular, pulmonary, immunological or hematological disease. Patients with alcohol-related liver disease as reflected by diffuse elevations in liver functions tests exceeding the upper limits of the normal range by 50% will be excluded.
- •Patients who are pregnant or plan to become pregnant during the study.
- •Patients who have received haloperidol decanoate or fluphenazine decanoate within the last 10 weeks.
- •Patients who have a central nervous system (CNS) neoplasm, uncontrolled metabolic, demyelinating or progressive disorder; active CNS infection; or any progressive neurological disorder.
- •Patients who are taking exogenous steroids.
- •Patients who do not meet criteria for substance abuse or dependence.
研究组 & 干预措施
Lithium plus Divalproex
Patients assigned to the combination group were continued on lithium and blinded divalproex.
干预措施: Lithium (Drug)
Lithium plus Divalproex
Patients assigned to the combination group were continued on lithium and blinded divalproex.
干预措施: Divalproex (Drug)
Lithium plus placebo
Patients assigned to lithium monotherapy underwent divalproex-placebo substitution at a rate of 250 mg decrements every week until discontinued.
干预措施: Lithium (Drug)
Lithium plus placebo
Patients assigned to lithium monotherapy underwent divalproex-placebo substitution at a rate of 250 mg decrements every week until discontinued.
干预措施: Placebo (Drug)
结局指标
主要结局
Time to Treatment for Emerging Symptoms of a Mood Relapse
时间窗: Up to 6 months
A relapse is a return to either a depressive, manic, hypomanic or mixed episode after a period of not have any symptoms.
次要结局
- Time to Treatment for Emerging Symptoms of a Manic/Hypomanic/Mixed Episode(Up to 6 months)
- Time to Treatment for Emerging Symptoms of a Depressive Episode(Up to 6 months)
- Change in Rate of Alcohol Use Disorders After Open-label Treatment With Lithium and Divalproex(Baseline to Month 6)
- Change in Rate of Cannabis Use Disorders After Open-label Treatment With Lithium and Divalproex(Baseline to Month 6)
- Change in Rate of Cocaine Use Disorders After Open-label Treatment With Lithium and Divalproex(Baseline to Month 6)
研究者
Joseph Calabrese, MD
Director, Mood Disorders Program
University Hospitals Cleveland Medical Center