Efficacy and safety profile of Vortioxetine as an add-on molecule in Obsessive-Compulsive Disorder; A Randomized Double-Blinded Placebo-Controlled Superiority Trial
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- Reduction in the OCD symptoms measured by YBOCS (Yale Brown Obsessive Compulsive Scale).
研究概览
简要总结
This interventional drug trial explores the effectiveness and safety of Vortioxetine as an additional treatment for Obsessive-Compulsive Disorder (OCD). Conducted at AIIMS, Kalyani, the study is a Randomized, Parallel Group, Placebo-Controlled Superiority Trial, enrolling 114 participants aged between 18 and 65, diagnosed with moderate to severe OCD. Participants are randomized into two groups: a control group receiving Escitalopram with a placebo, and an intervention group receiving both Escitalopram and Vortioxetine. The primary outcome is the reduction in OCD symptoms, measured by the Yale Brown Obsessive Compulsive Scale (YBOCS) at 4, 8, and 12 weeks post-recruitment. Secondary outcomes include disease severity assessment, extensive improvement, and drug efficacy index as measured by the Clinical Global Impression Scale (CGI), along with monitoring any Adverse Drug Reactions to Vortioxetine. Through this trial, researchers aim to ascertain whether Vortioxetine as an add-on treatment can significantly alleviate OCD symptoms, thereby providing evidence for its efficacy and safety in this new therapeutic indication.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor 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
- •Patients diagnosed with OCD as per ICD 11 by a psychiatrist ii.
- •OCD rated as moderate to severe (YBOCS score 16+) iii.
- •Patients who are drug naïve or have not taken any SRIs for the last 7 days at least.
排除标准
- •Patients with psychotic symptoms ii.
- •Patients with co-morbid major psychiatric illness iii.
- •Patients with comorbid substance use disorder in dependence pattern except tobacco and caffeine.
- •Pregnant and lactating mothers.
- •Patients with co-morbid medical or neurological illness vi.
- •Patients with history of adverse drug reaction to Vortioxetine in the past.
结局指标
主要结局
Reduction in the OCD symptoms measured by YBOCS (Yale Brown Obsessive Compulsive Scale).
时间窗: Follow-up assessments of all participants will be conducted at 4 weeks, 8 weeks and 12 weeks from their recruitment
次要结局
- Assessment of Disease severity, extensive improvement or change in disease process(and Efficacy index of the drug as measured by Clinical Global Impression Scale (CGI))
- To monitor the presence of any Adverse Drug reactions with Vortioxetine as measured by history clinical examination and Antidepressant Side effect Checklist