CTRI/2023/12/060745尚未招募Phase 3 4
A Randomized Double Blind Placebo Controlled trial Evaluating the Efficacy of Alpha Lipoic Acid as Add-On Therapy on Cognitive Impairment in Schizophrenia Patients of a Tertiary Care Hospital
Dr Ramya R1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2023年12月30日最近更新:
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- 1) Effect of alpha lipoic acid on executive functioning-attention, inhibition, working memory, Orientation through Montreal Cognition Assessment scale
研究概览
简要总结
Study hypothesis is to show that Alpha lipoic acid as an adjuvant along with the routine treatment is more efficacious than placebo in improving cognitive impairment among schizophrenia patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Double
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Schizophrenia diagnosis made by research psychiatrists using the Structured Clinical Interview, SCID-5, for Diagnostic and Statistical Manual of Mental Disorders of more than 2 years duration and on treatment 2)Cognitive symptoms despite adequate antipsychotic treatment assessed by MOCA scored < 26 3)Age 18-60 years of either gender 4)Willing to participate.
排除标准
- •6-months history of any drug or alcohol abuse or dependence 2)Changes in psychotropic medications within the last 4 weeks and patients on valproate use (potential interaction with ALA) 3)Women who are planning to become pregnant, are pregnant, or are breastfeeding 4)Known chronic infections such as HIV or hepatitis C, and liver or renal failure that could adversely impact on patient outcome.
结局指标
主要结局
1) Effect of alpha lipoic acid on executive functioning-attention, inhibition, working memory, Orientation through Montreal Cognition Assessment scale
时间窗: Baseline to 12 weeks
次要结局
- 1)Effect of alpha lipoic acid on improving cognition and disability(2) Effect of alpha lipoic acid on quality of life)
研究者
Dr Ramya R
SRM medical college
研究点 (1)
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