To study the efficacy and safety of Aripiprazole vs Naltrexone in managing antipsychotic induced weight gain- A randomized controlled trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To assess and compare the effectiveness of Aripiprazole and Naltrexone in managing antipsychotic induced weight gain
研究概览
简要总结
The pathophysiology of antipsychotic induced weight gain is poorly understood. Aripiprazole and Naltrexone have two different mechanism of action and theoritically can benefit antipsychotic induced weight gain.This study will help to identify underlying gaps that favour response to a particular molecule thus help in identifying subgroups with a pathophysiological mechanism with indirect theraputic evidence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients who are on antipsychotic treatment for a duration of at least 3 months
- •who have gained weight by 5 % in the last 3 months.
- •All patients irrespective of gender and diagnosis
- •Female participants of childbearing potential to have a negative pregnancy test at screening and pre-dose, and willing to practice adequate methods of contraception during the study.
排除标准
- •1.Those who have hypersensitivity to aripiprazole or naltrexone
- •Those who develop side effects that are bothersome including Fulminant hepatitis or extreme hypersensitivity reactions.
- •Those with uncontrolled thyroid disorder or uncontrolled diabetes mellitus.
- •Among females, those who are pregnant or lactating
- •Current alcohol or substance abuse or dependence
- •Those who used any medication for weight loss within the preceding month prior to study entry.
结局指标
主要结局
To assess and compare the effectiveness of Aripiprazole and Naltrexone in managing antipsychotic induced weight gain
时间窗: They will be contacted telephonically every week and will follow up in psychiatry OPD,every 2 weeks to observe for medication tolerability and side effects. Pill counting and informant report will be used to ascertain compliance to the prescribed medications.
次要结局
- 1.To identify parameters of sociodemographic, metabolic profile, behavioral phenotype, eating behavior associated with response to aripiprazole and naltrexone.(2.To study the Adverse drug reaction profile of Aripiprazole vs Naltrexone in Antipsychotic induced weight gain.)
研究者
Madhurima Dhar
Kalinga Institute of Medical Sciences