Pioglitazone as an Adjunct for Moderate to Severe Depressive Disorder
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Scores of Hamilton Depression Rating Scale (17 items) at the end
研究概览
简要总结
The purpose of this study is to determine whether Pioglitazone as an adjunct to Citalopram is effective in treatment of moderate to severe depression
详细描述
Pioglitazone as a Ppar-gamma agonist is an anti diabetic drug. It was also shown that, it has certain anti inflammatory and neuro-protective effects. In recent years it has been proposed that Ppar-gamma agonists may have effects on mood and cognition. In animal studies and in one human case report as well as a pilot study on human subjects these drugs improved symptoms of depression. A randomized controlled and double blind design will provide further evidence for the efficacy of these drugs in major depressive disorder.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Major depressive disorder based on DSM-IV TR criteria
- •Age 18-50
- •Hamilton Depression Rating scale >=22
- •Signing the informed consent form
- •Citalopram be the drug of choice for the patient irrespective of other eligibility criteria
排除标准
- •Problems in other Axes
- •Pregnancy and lactation
- •Serious or life threatening disease
- •taking other antidepressant in the recent month or Electroconvulsive shock in the recent two months, and taking other psychotropic agents
- •Diabetes controlled with drugs or insulin (patients with only lifestyle interventions will be included), Liver disease, Congestive heart failure Class III and IV
- •Metabolic syndrome
研究组 & 干预措施
Pioglitazone+Citalopram+Chlordiazepoxide
Pioglitazone 15 mg Q12h will be given to the patients in active comparator group for 6 weeks. Citalopram 20 mg per day for week one, and then 30 mg/day for 5 consecutive weeks.Chlordiazepoxide 10 mg/day for first three weeks
干预措施: Pioglitazone+Citalopram+Chlordiazepoxide (Drug)
Placebo+ Citalopram+ Chlordiazepoxide
Placebo 1 Q12h for 6 weeks with the same shape and color as Pioglitazone. Citalopram 20 mg per day for week one, and then 30 mg/day for 5 consecutive weeks.
Chlordiazepoxide 10 mg each night for first three weeks.
干预措施: Placebo+ Citalopram+ Chlordiazepoxide (Drug)
结局指标
主要结局
Scores of Hamilton Depression Rating Scale (17 items) at the end
时间窗: week 6
Hamilton Depression rating scale is a 17-item scale. The questionnaire rates the severity of symptoms observed in depression such as low mood, insomnia, agitation, anxiety and weight loss. The questionnaire is presently one of the most commonly used scales for rating depression in medical research. The primary outcome measure is Scores on Hamilton Depression Rating Scale at the end (week 6)
次要结局
- Number of Adverse events in each group(week 2,4,6)
- Scores of Hamilton Depression Rating Scale (17 items)(week 0,2,4)
研究者
Amirhossein Modabbernia
Dr Amirhossein Modabbernia
Tehran University of Medical Sciences