Evaluating The Efficacy And Safety Of Ondansetron As Augmentation Of Fluoxetine In Obsessive-Compulsive Disorder: A Comparative Study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Improvement in YBOCS,MADRS,CGI-I, HAM-A ,UKU Scales
研究概览
简要总结
Potential participants will be screened for eligibility based on the inclusion and exclusion criteria.Participants will undergo baseline assessments to collect demographic information, medical history, psychiatric history, and baseline clinical variables will be measuresd YBOCS Scale And Symptoms Checklist, MADRS, HAM-A and CGI-I Scale.Participants will be randomized to either the ondansetron augmentation group (Group A) or the no augmentation group (group B). Fluoxetine therapy will be given in both the groups. Benzodiazepines (Lorazepam) upto 3 mg/day and beta-blocker (Propranolol) at a dose of 20-80 mg/day can be used as concomitant medication, if required.Participants will undergo regular follow-up assessments at 4 week and 8 week, Outcome measures including severity of OCD , depression and overall improvement will be assessed using standardized Scales
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patient willing to participate in the study and has given written informed consent.
- •2.Age group 18-60 years.
- •3.Patients diagnosed with Obsessive-Compulsive Disorder according to DSM-5 TR.(12) 4.Currently naïve or off any psychotropic medication for at least 6 weeks.
排除标准
- •1.Treatment resistant OCD (2 adequate SSRI trial for 12 weeks) 2.History of non response to prior trial of fluoxetine with ondansetron.
- •3.Patient having severe psychiatric or medical comorbidities except depression.
- •4.Substance use disorder except nicotine and caffeine.
- •5.Pregnancy or lactation.
- •6.Patients with history of adverse reaction to study medications.
- •7.Inability to provide informed consent.
- •8.Patient with psychotic symptoms due to other organic illness.
结局指标
主要结局
Improvement in YBOCS,MADRS,CGI-I, HAM-A ,UKU Scales
时间窗: Improvement in YBOCS,MADRS,CGI-I, HAM-A ,UKU Scales
次要结局
未报告次要终点
研究者
Nidhi Kulhar
SN Medical College Agra