Pioglitazone for the Treatment of Bipolar Disorder and Comorbid Metabolic Syndrome or Insulin Resistance
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Change in the Inventory of Depressive Symptomatology-Clinician Rated (IDS-CR) Score
研究概览
简要总结
The study is an open-label 8-week adjunctive trial of pioglitazone for the acute relief of bipolar depression comorbid with metabolic syndrome/insulin resistance. Subjects who experience a partial or full response will have the option of continuing in an acute continuation phase lasting up to 12 weeks. The extension phase will allow assessment of the safety and tolerability of pioglitazone during the acute continuation period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be male or female between the ages of 18 and 70
- •Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV diagnosis of bipolar disorder (type I, II, or NOS)
- •Currently depressed as confirmed by the MINI-Plus at the screening visit
- •Currently receiving treatment with an anti-manic drug
- •Meets criteria for metabolic syndrome or insulin resistance
排除标准
- •Pregnancy or breast feeding
- •Unstable or inadequately treated medical illness as judged by the investigator
- •Severe personality disorder
- •Serious suicidal risk
- •Known history of intolerance or hypersensitivity to pioglitazone
- •Treatment with pioglitazone in the 3 months prior to randomization
- •Dependence on alcohol or drugs (other than nicotine) in the 3 months prior to study entry
- •Currently taking an antidiabetic/glucose-lowering agent.
- •Diagnosed with dementia
- •Acute Mania as defined by a Young Mania Rating Scale (YMRS) score > 15
- •Diagnosed with heart failure
- •Transaminase elevation >2.5 times the upper limit of normal
- •Presence of renal impairment (eg. creatinine > 1.5)
- •Fasting blood glucose >150 mg/dL
- •Hb A1c > 7.5%
研究组 & 干预措施
Pioglitazone
Pioglitazone has been approved by the U.S. Food and Drug Administration (FDA) to help people who are diagnosed with diabetes
干预措施: Pioglitazone (Drug)
结局指标
主要结局
Change in the Inventory of Depressive Symptomatology-Clinician Rated (IDS-CR) Score
时间窗: Week 0 - Week 8
Inventory of Depressive Symptoms-Clinician rated, 30 item (IDS-C30) score change from baseline to study endpoint. IDS-C30 total scores can range from 0 to 84, with higher scores indicating a worse outcome
次要结局
- Change in Quick Inventory of Depressive Symptoms-Self Report (QIDS-SR16) Total Score(Week 0 - Week 8)
- Response Rates on the IDS-CR, Montgomery Asberg Depression Rating Scale (MADRS) and Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR)(Week 0 - Week 8)
- Remission Rates Based on IDS-CR, QIDS-SR, and MADRS Scores(Week 0 - Week 8)
- Change in Clinical Global Impressions-Bipolar Version (CGI-BP)(Week 0 - Week 8)
研究者
Joseph Calabrese, MD
Director, Mood Disorders Program
University Hospitals Cleveland Medical Center