NCT04761861撤回2 期
Vildagliptin for Treatment of Antipsychotic-induced Dyslipidemia: a Randomized, Double-blind, Placebo-controlled Study
Sadat City University1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2021年2月16日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- low-density lipoprotein cholesterol
研究概览
简要总结
Almost all antipsychotics can induce dyslipidemia, but no treatment has been established. Vildagliptin can improve lipid levels in obese patients. The investigators conducted a randomized, placebo-controlled study to test the efficacy of vildagliptin for antipsychotic-induced dyslipidemia.
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
- •Diagnostic and Statistical Manual of Mental Disorder-Fourth Edition (DSM-Ⅳ) criteria for schizophrenia dyslipidemia after antipsycotic treatment the duration of illness was less than 12 months taking only one antipsychotic stable outpatient the total score of Positive and Negative Syndrome Scale (PANSS)≤60.
排除标准
- •liver or renal diseases pregnant or lactating women cardiovascular diseases hypertension or diabetes mellitus
研究组 & 干预措施
Vildagliptin
Experimental
Vildagliptin 50 mg tablet daily
干预措施: Vildagliptin 50 MG (Drug)
Placebo
Placebo Comparator
Placebo tablet daily
干预措施: Placebo (Drug)
结局指标
主要结局
low-density lipoprotein cholesterol
时间窗: week 12
low-density lipoprotein cholesterol
次要结局
- TNF-alpha serum level(12 weeks)
- high-density lipoprotein cholesterol(week 12)
- Adverse drug reactions(12 weeks)
- FAM19A5 serum level(12 weeks)
- Serum stem cell growth factor beta(week 12)
研究者
Mahmoud Samy Abdallah
Lecturer of Clinical Pharmacy
Sadat City University
研究点 (1)
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