Risperidone vs Cariprazine in Acute Mania a Head to Head Comparison of Efficacy vs Tolerability
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 50
研究概览
简要总结
Randomized, double-blind, parallel-group study comparing efficacy and safety of Risperidone versus Cariprazine in adults with acute manic episodes. Participants will receive oral study drug for 6 weeks. Primary outcome is change in YMRS total score from baseline to week 6.
详细描述
This is a randomized, double-blind, active-controlled, parallel assignment clinical trial conducted at Pakistan Institute of Medical Sciences, Islamabad. Adults aged 18-65 with ICD 11 diagnosis of Bipolar I Disorder, current episode manic, will be randomized 1:1 to receive Risperidone or Cariprazine for 6 weeks. The study aims to compare reduction in mania symptom severity and tolerability between the two antipsychotics. Assessments include YMRS, UKU and safety parameters at baseline, week 3, and week 6.'
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
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with bipolar mania Age 18-60 YMRS>20 -
排除标准
- •Patients with substance use Patients already taking antipsychotics Secondary mood disorder
研究者
Maera Hussain
Resident psychiatrist Pims
Pakistan Institute of Medical Sciences