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A randomized placebo-controlled trial of vortioxetine for obsessive-compulsive disorder

Efficacy and safety profile of Vortioxetine as an add-on molecule in Obsessive-Compulsive Disorder; A Randomized Double-Blinded Placebo-Controlled Superiority Trial - Not applicable

Status
Recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/12/060748
Enrollment
114
Registered
2023-12-26
Start date
Unknown
Completion date
Unknown
Last updated
2025-05-26

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: Tab Vortioxetine as an add on molecule will be given with Tab Escitalopram: The Intervention population group will be initiated on treatment with Tab. Escitalopram 10mg, with dosage inc

Sponsors

Indican Council of Medical Research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: i. 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.

Exclusion criteria

Exclusion criteria: i. 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. iv. Pregnant and lactating mothers. v. Patients with co-morbid medical or neurological illness vi. Patients with history of adverse drug reaction to Vortioxetine in the past

Design outcomes

Primary

MeasureTime frame
Reduction in the OCD symptoms measured by YBOCS (Yale Brown Obsessive Compulsive Scale).Timepoint: Follow-up assessments of all participants will be conducted at 4 weeks, 8 weeks and 12 weeks from their recruitment

Secondary

MeasureTime frame
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)Timepoint: Follow-up assessments of all participants will be conducted at 4 weeks, 8 weeks, and 12 weeks from their recruitment;To monitor the presence of any Adverse Drug reactions with Vortioxetine as measured by history clinical examination and Antidepressant Side effect Checklist Timepoint: Follow-up assessments of all participants will be conducted at 4 weeks, 8 weeks and 12 weeks from their recruitment

Countries

India

Contacts

Public ContactKaushik Mukhopadhyay

AIIMS, Kalyani

kaushik.pharm@aiimskalyani.edu.in09163167014

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026