A total of 114 participants will be recruited for a randomized, double-blind, placebo-controlled trial of vortioxetine in OCD treatment.
Vortioxetine is being evaluated as an adjunctive treatment for individuals diagnosed with Obsessive-Compulsive Disorder (OCD).
The trial aims to assess the effectiveness and safety of vortioxetine in combination with escitalopram compared to a placebo with escitalopram.
Outcomes will be measured using the (Y-BOCS) and the Clinical Global Impressions () at 4, 8, and 12 weeks.
The study is designed to detect a clinically meaningful difference of 5 units between treatment groups with 80% statistical power.
Adverse events reported by participants will be documented throughout the trial.
Simplified
BACKGROUND: Obsessive-Compulsive Disorder (OCD) affects approximately 2-3% of the global population and is associated with significant functional impairment and reduced quality of life. Despite its widespread impact, pharmacological treatments approved by the U.S. Food and Drug Administration (FDA) for OCD remain limited. Vortioxetine is a multimodal antidepressant that obtained its FDA approval in December 2013 for Major Depressive Disorder (MDD) and has shown to have some potential benefits in terms of cognitive aspects and global manifestation of symptoms. The purpose of this study is to assess the effectiveness and safety of vortioxetine as adjunctive treatment in patients with a diagnosis of OCD.
METHODS/DESIGN: A randomized, double-blind, placebo-controlled superiority trial, developed in accordance with CONSORT guidelines, will assess the efficacy and safety of vortioxetine in individuals diagnosed with OCD. A total of 114 participants who meet all eligibility criteria will be recruited and randomly allocated, using block randomization, into two equal treatment arms (n = 57 per group) following informed consent. The sample size provides 80% statistical power at a 5% significance level to detect a clinically meaningful difference of 5 units between the intervention and control groups. The experimental group will receive vortioxetine combined with escitalopram, and the control group will be administered a placebo with escitalopram. Demographic characteristics and disease profile at baseline will be collected using Case Report Forms (CRFs). The (Y-BOCS) and the Clinical Global Impressions () will be used to evaluate the outcomes at 4, 8, and 12 weeks. The Adverse Events and Side Events Checklist (ASEC) will document any adverse events reported by the patient throughout the trial participation.
DISCUSSION: Vortioxetine's unique pharmacological profile may offer significant benefits to managing cognitive symptoms and improving the quality of life of OCD patients. This clinical trial aims to provide evidence on the clinical value and safety of vortioxetine in the management of OCD in order to advance the optimization of more effective and personalized treatment plans.
TRIAL REGISTRATION: The trial was registered with the Clinical Trials Registry - India (CTRI) (registration ID: CTRI/2023/12/060748) on December 26, 2023.
Key numbers
114
Sample Size
Total participants planned for the study, with 57 in each group.
12 weeks
Treatment Duration
Duration of treatment for both intervention and control groups.
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Declarations. Ethics approval and consent to participate: The clinical trial commenced only after obtaining prior written approval from the Institutional Ethics Committee (IEC) of AIIMS Kalyani and successful registration with the Clinical Trials Registry - India (CTRI). As this is an academic clinical trial involving a drug already approved for a different indication (vortioxetine for major depressive disorder), permission from the Central Licensing Authority (CLA) under the DCGI was not required. The study adheres strictly to the ethical principles outlined in the Declaration of Helsinki and complies with the Indian Council of Medical Research (ICMR) guidelines for biomedical research involving human participants. Written informed consent is obtained from all participants in their native language, ensuring they fully understand the study procedures, potential risks, benefits, and their right to withdraw at any stage without any consequences. No participant is subjected to financial burden; all costs associated with the study are borne by the institution. The confidentiality of all participant data is maintained. Identifiable information is de-identified prior to analysis, and data is stored securely with restricted access limited to authorized study investigators. Participants are also provided with the contact details of both the principal investigator and the ethics committee to report any concerns or adverse events. Consent for publication: Not applicable, as the protocol does not include any individual person’s data in any form, including images, videos, or clinical details. Competing interests: The authors declare no competing interests.
