EFFECT OF RISPERIDONE vs ARIPIPRAZOLE ON OXIDATIVE STRESS IN PATIENTS WITH AUTISM SPECTRUM DISORDER: A RANDOMIZED CONTROLLED TRIAL
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 42
- 主要终点
- Change in serum Glutathione levels following 6 weeks of intervention in both the arms
研究概览
简要总结
The goal of this Randomized Controlled Trial is to to compare the effect of Risperidone vs Aripiprazole in terms of change in serum Glutathione level in patients with Autism Spectrum Disorder over a period of 6 weeks.
The main questions it aims to answer are:
- (Primary Outcome) Change in serum Glutathione levels following 6 weeks of intervention in both the arms
- (Secondary Outcomes) Change in serum superoxide dismutase (SOD) levels following 6 weeks of intervention.
Change in ISAA score following 6 weeks of intervention. Change in ABC-C score following 6 weeks of intervention. • Adverse events reported in both groups
Details of intervention- One arm of the study population to get Risperidone 1mg/day for a total duration of 6 weeks and another arm to get Aripiprazole 2mg/day for a total duration of 6 weeks. Baseline assessment of Serum Glutathione, Serum SOD, ISAA scale, ABC-C scale will be done and same will be assesssed at 6 weeks follow up.
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, Care Provider)
入排标准
- 年龄范围
- 5 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria:
- •Patients diagnosed with Autism Spectrum Disorder (according to ICD-11 DCR) under the age group of 18 years.
- •Legally authorized representative (LAR) giving voluntary written consent for participation in the study.
排除标准
- •History of ADHD
- •History of any major genetic disorder/ storage disorder/ any special syndromes.
- •History of seizure disorder or any major medical or surgical disorders
- •Legally authorized representative (LAR) not giving voluntary written consent for participation in the study.
研究组 & 干预措施
Risperidone group
干预措施: Risperidone, Aripiprazole (Drug)
Aripiprazole group
干预措施: Risperidone, Aripiprazole (Drug)
结局指标
主要结局
Change in serum Glutathione levels following 6 weeks of intervention in both the arms
时间窗: 6 weeks
Change in serum Glutathione levels following 6 weeks of intervention in both the arms
次要结局
- Change in ISAA score following 6 weeks of intervention.(6 weeks)
- Adverse events reported in both groups(6 weeks)
- Change in serum superoxide dismutase (SOD) levels following 6 weeks of intervention.(6 weeks)
- Change in ABC-C score following 6 weeks of intervention. •(6 weeks)
研究者
Dr. Debadatta Mohapatra
Assistant Professor
All India Institute of Medical Sciences, Bhubaneswar