To assess the effectiveness and safety of adding L-methyltetrahydrofolate in addition to fluvoxamine in patients with Obsessive compulsive Disorder
Phase 4
- Conditions
- Health Condition 1: F42- Obsessive-compulsive disorder
- Registration Number
- CTRI/2024/05/067542
- Lead Sponsor
- PT B.D Sharma UHS Rohtak
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1)Age 18-65 years
2)Patient fulfilling the criteria of OCD as
per ICD-11 any severity YBOCS score more than
8.
3) Willing to participate and give
informed consent
Exclusion Criteria
1) Current diagnosis of OCD with
psychotic features or any other
psychiatric diagnosis in the past
2) Patient with a history of any
chronic physical illness
3) Current psychoactive substance use
• Pregnant and lactating women
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Improvement in Y- BOCS scale <br/ ><br>2. Improvement in CGI scaleTimepoint: Baseline,2,4,6 and 12 weeks
- Secondary Outcome Measures
Name Time Method 1.Number of patients who withdrew from study due to ADR’s of drugs. <br/ ><br>2. Number of patients requiring augmentation of fluvoxamine therapy <br/ ><br>3.Mean dose of fluvoxamine required in both groupsTimepoint: 1.Safety assessment will be carried out for both the treatment groups at 2, 4, 6 and 12 <br/ ><br>weeks. <br/ ><br>2.drug response at the end of 2,4,6 and 12 weeks