Efficacy and safety profile of Vortioxetine as an add-on molecule in Obsessive-Compulsive Disorder; A Randomized Double-Blinded Placebo-Controlled Superiority Trial
Trial Snapshot
- Phase
- Phase 2/3
- Status
- Recruiting
- Sponsor
- Enrollment
- 114
- Locations
- 1
- Primary Endpoint
- Reduction in the OCD symptoms measured by YBOCS (Yale Brown Obsessive Compulsive Scale).
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Participant, Investigator and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •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
- •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.
Outcomes
Primary Outcomes
Reduction in the OCD symptoms measured by YBOCS (Yale Brown Obsessive Compulsive Scale).
Time Frame: Follow-up assessments of all participants will be conducted at 4 weeks, 8 weeks and 12 weeks from their recruitment
Secondary Outcomes
- 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