The DPP-4 Inhibitor Vildagliptin as Adjunct in Major Depressive Disorder Patients: A Proof-of-Concept, Randomized, Double-Blind, Placebo-Controlled Trial
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Effect on Hamilton Depression rating scale score (HAM-D score)
研究概览
简要总结
Vildagliptin, an antidiabetic drug that inhibits the dipeptidyl peptidase- 4 (DPP-4), increases glucagon-like peptide-1 (GLP-1) and regulates blood glucose levels, favoring weight loss and lowering cardiovascular risk. A retrospective longitudinal study by Rizzo et al. showed that DPP-4 inhibitors administration could have protective effects against cognitive decline in diabetic elderly. Is has been observed that GLP-1 affects brain metabolism, increases neuritic growth, and protects neuronal cells from oxidative stress and death.
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 60 Years（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
- •Cardiovascular disorders
- •Severe renal impairment: creatinine clearance of ≤ 25 ml/min
- •Moderate or severe hepatic impairment
研究组 & 干预措施
Placebo group
Escitalopram 20 mg tablet once daily for 12 week plus placebo tablet once daily for 12 weeks
干预措施: Escitalopram 20 mg (Drug)
Vildagliptin group
Escitalopram 20 mg tablet once daily for 12 week plus Vildagliptin 50mg tablet once daily for 12 weeks
干预措施: Vildagliptin 50 MG (Drug)
Vildagliptin group
Escitalopram 20 mg tablet once daily for 12 week plus Vildagliptin 50mg tablet once daily for 12 weeks
干预措施: Escitalopram 20 mg (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
- Interleukin-6(Baseline and 12 week)
- Effect on biological markers(Baseline and 12 week)
- BDNF(Baseline and 12 week)
研究者
Mahmoud Samy Abdallah
Lecturer of Clinical Pharmacy, PhD.
Sadat City University