NCT01384279已完成不适用
The Therapeutic Effects of Topiramate and Metformin on Second Generation Antipsychotics-induced Obesity
Beitou Armed Forces Hospital, Taipei, Taiwan1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2011年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- The changes in metabolic panel as the primary outcome
研究概览
简要总结
The primary aim of the study is to investigate the efficacy of metformin and topiramate on second-generation antipsychotic-induced obesity. The secondary domain we look at is the adverse effects of both drugs. The investigators hypothesize that metformin and topiramate are effective in treating obesity induced by second-generation antipsychotics.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis: schizophrenia or schizoaffective disorder
- •Age: 20 to 65
- •Receiving second-generation antipsychotics(Olanzapine, Clozapine, Quetiapine, Risperidone, Amisulpride, Zotepine)
排除标准
- •Allergy to metformin or topiramate
- •Currently taking metformin or topiramate
- •Currently taking drugs that may interact with topiramate, including carbamazepine, eslicarbazepine, oxcarbazepine, phenobarbital, phenytoin, primidone, amitriptyline, lithium, metformin, propranolol, and sumatriptan.
- •Being pregnant or planning to become pregnant during the study period,
- •History of hypertension, DM, liver or renal function impairment, cardiovascular disease, CVA, or neurological disorders
- •History of hypoglycemia
- •History of suicidal attempt
- •Current scale of Hamilton Depression Rating Scale>8
研究组 & 干预措施
metformin, topiramate
Experimental
干预措施: metformin, topiramate (Drug)
结局指标
主要结局
The changes in metabolic panel as the primary outcome
时间窗: up to six months
Metabolic panel, which includes HDL-C, VLDL, LDL, cholesterol, triglycerides, insulin, leptin, BW, Glucose, blood pressure, and weight(with waist circumference and BMI) will be assessed every month
次要结局
- Number of Participants with Adverse Events (including psychiatric adverse events) as a Measure of Safety and Tolerability(up to six months)
研究者
Kuo-Tung Chiang
Beitou Armed Forces Hospital
Beitou Armed Forces Hospital, Taipei, Taiwan
研究点 (1)
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