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To assess the effectiveness and safety of adding L-methyltetrahydrofolate in addition to fluvoxamine in patients with Obsessive compulsive Disorder

Efficacy and Safety of Fluvoxamine alone and in combination with L-Methyltetrafolate in patients with Obsessive Compulsive Disorder - nil

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/05/067542
Enrollment
76
Registered
2024-05-17
Start date
Unknown
Completion date
Unknown
Last updated
2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: F42- Obsessive-compulsive disorder

Interventions

Intervention1: Fluvoxamine 50 mg once daily for 12 weeks initially and can be increased upto 250 mg, if required.: Assess efficacy using Y BOCS Scale and CGI scale at baseline,2,4,6, and 12 weeks. Saf

Sponsors

PT B.D Sharma UHS Rohtak
Lead Sponsor

Eligibility

Inclusion criteria

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

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 â?¢ Pregnant and lactating women

Design outcomes

Primary

MeasureTime frame
1.Improvement in Y- BOCS scale 2. Improvement in CGI scaleTimepoint: Baseline,2,4,6 and 12 weeks

Secondary

MeasureTime frame
1.Number of patients who withdrew from study due to ADRâ??s of drugs. 2. Number of patients requiring augmentation of fluvoxamine therapy 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 weeks. 2.drug response at the end of 2,4,6 and 12 weeks

Countries

India

Contacts

Public ContactDr Ekta Sharma

PT B.D. SHARMA UNIVERSITY OF HEALTH SCIENCE PGIMS ROHTAK

ektasharma011296@gmail.com9588166028

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026