Pentoxifylline as a New Adjuvant in Adult Patients With Major Depressive Disorder: Randomized, Double Blind, Placebo Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 主要终点
- Effect on Hamilton Depression rating scale score (HAM-D score)
研究概览
简要总结
This study aimed to evaluate the therapeutic benefits of pentoxifylline (PTX) in treatment of adult patients with MDD as it has anti-inflammatory and phosphodiastrase inhibition activities.
详细描述
In this study, the investigators evaluated the potential antidepressant effect of PTX in adult patients with MDD. the investigators hypothesized that MDD patients taking add-on PTX would present greater amelioration of their depressive symptoms than patients taking add-on placebo. Furthermore, the investigators assessed the relationship between HAM-D score and several peripheral biomarkers as well as their role in diagnosis and therapeutic targets of MDD.
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eighty adult outpatients with the Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) diagnosis of MDD based on a MINI Neuropsychiatric Interview (MINI) (American Psychiatric Association., 2000; Sheehan et al., 1998), without psychotic features and a total 17 item HAM-D score of at least 18 with item 1 (depressed mood) scored 2 or greater were eligible (Hamilton, 1960).
- •Patients were requested to be free of all the psychotropic and anti-inflammatory medications for at least 4 weeks before participating in the study.
排除标准
- •Patients with bipolar I or bipolar II disorder
- •Patients with personality disorders
- •Patients with eating disorders
- •Patients with substance dependence or abuse
- •Patients with concurrent active medical condition
- •Patients with history of seizures
- •Patients with history of receiving Electroconvulsive therapy (ECT)
- •Patients with inflammatory disorders
- •Patients with allergy or contraindications to the used medications
- •Patients with finally pregnant or lactating females
研究组 & 干预措施
Pentoxifylline group
Escitalopram 20 mg tablet once daily for 12 week plus Pentoxifylline 400 mg tablet twice daily for 12 weeks
干预措施: Escitalopram 20 mg tablet plus Pentoxifylline 400Mg Tablet (Drug)
Control group
Escitalopram 20 mg tablet once daily for 12 week plus placebo tablet twice daily for 12 weeks
干预措施: Escitalopram 20 mg tablet + Placebo (Drug)
结局指标
主要结局
Effect on Hamilton Depression rating scale score (HAM-D score)
时间窗: 12 week
The principal measure of the outcome was the 17-items HAM-D. Scoring is based on the 17-item scale and scores of 0-7 are considered as being normal, 8-13 suggest mild depression, 14-17 moderate depression and scores over 17 are indicative of severe depression. Remission is defined as HAM-D total score ≤ 7 (primary outcome). Treatment response is defined as ≥ 50% drop in the HAM-D total score.
次要结局
- Effect on biological markers(12 week)
研究者
Mahmoud Samy Abdallah
Principal Investigator
Sadat City University