Pioglitazone for the Treatment of Major Depressive Disorder Comorbid With Metabolic Syndrome
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Change in Depression Symptom Severity From Baseline to Study Endpoint
研究概览
简要总结
The goal of this study is to begin to test whether or not pioglitazone, an FDA approved medication used to treat high blood sugar, may be safe and effective in treating Major Depressive Disorder (MDD) in patients with comorbid Metabolic Syndrome (METSYN).
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
- •DSM-IV diagnosis of major depressive disorder
- •Currently depressed as confirmed by the MINI-Plus at the screening visit
- •Quick Inventory of Depressive Symptomatology-Self-Report(QIDS-SR) score > 11 at study baseline
- •Meets criteria for the metabolic syndrome as defined by the NCEP ATP III criteria
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 as judged by the investigator or having a score > 2 on item 18 of the Inventory of Depressive Symptomatology-Clinician Rated (IDS-CR) scale
- •Known history of intolerance or hypersensitivity to pioglitazone
- •Treatment with pioglitazone in the 3 months prior to randomization
- •Currently taking an antidiabetic/glucose-lowering agent. Antidiabetic agents that are prohibited include insulin, rosiglitazone, metformin, sitagliptin, sulfonylureas (e.g. glyburide, glipizide, glimepiride), non-sulfonylurea secretagogues (e.g. repaglinide, nateglinide), incretins (e.g. exenatide), and α-glucosidase inhibitors (e.g. acarbose, miglitol).
- •Diagnosed with dementia
- •Diagnosed with heart failure
- •Transaminase elevation >2.5 times the upper limit of normal
- •Presence of renal impairment
研究组 & 干预措施
Pioglitazone
An open-label 12-week trial of pioglitazone monotherapy. The investigators will titrate pioglitazone to the maximum tolerable dose up to 45mg per day.
干预措施: Pioglitazone (Drug)
结局指标
主要结局
Change in Depression Symptom Severity From Baseline to Study Endpoint
时间窗: Week 0 - Week 12
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 Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) From Baseline to Study Endpoint(Week 0-Week 12)
研究者
Joseph Calabrese, MD
Director, Mood Disorders Program
University Hospitals Cleveland Medical Center