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CTRI Number  CTRI/2023/12/060748 [Registered on: 26/12/2023] Trial Registered Prospectively
Last Modified On: 15/05/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A randomized placebo-controlled trial of vortioxetine for obsessive-compulsive disorder 
Scientific Title of Study   Efficacy and safety profile of Vortioxetine as an add-on molecule in Obsessive-Compulsive Disorder; A Randomized Double-Blinded Placebo-Controlled Superiority Trial 
Trial Acronym  Not applicable 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sucharita Mandal 
Designation  Assistant Professor 
Affiliation  AIIMS, Kalyani 
Address  AIIMS, Dept of Psychiatry, Kalyani, NH-34 Connector, Saguna

Nadia
WEST BENGAL
741245
India 
Phone  8420281546  
Fax    
Email  sucharita.psy@aiimskalyani.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Kaushik Mukhopadhyay 
Designation  Associate Professor 
Affiliation  AIIMS, Kalyani 
Address  Room No-306,Department of Pharmacology,AIIMS, Kalyani, NH-34 Connector,Basantapur,Saguna

Nadia
WEST BENGAL
741245
India 
Phone  09163167014  
Fax    
Email  kaushik.pharm@aiimskalyani.edu.in  
 
Details of Contact Person
Public Query  
Name  Kaushik Mukhopadhyay 
Designation  Associate Professor 
Affiliation  AIIMS, Kalyani 
Address  Room No-306,Department of Pharmacology,AIIMS, Kalyani, NH-34 Connector,Basantapur, Saguna

Nadia
WEST BENGAL
741245
India 
Phone  09163167014  
Fax    
Email  kaushik.pharm@aiimskalyani.edu.in  
 
Source of Monetary or Material Support  
Funded by Indican Council of Medical Research 
 
Primary Sponsor  
Name  Indican Council of Medical Research 
Address  Division of Bio-Medical Informatics(BMI), Indian Council of Medical Research, Department of Health Research, Ministry of Health & Family Welfare, Government of India, Ansari Nagar, New Delhi - 110029, India www.icmr.gov.in 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sucharita Mandal  All India Institute of Medical Sciences,Kalyani  Room No-316,Department of PsychiatryAIIMS, Kalyani, NH-34 Connector, Saguna, 741245
Nadia
WEST BENGAL 		 8420281546

sucharita.psy@aiimskalyani.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F42||Obsessive-compulsive disorder,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Tab Escitalopram with placebo  The control population will also be initiated on treatment with Tab. Escitalopram 10 mg, with a planned escalation to 20 mg over the course of 10 days. However, this group will receive a placebo medication that is designed to have similar colour, shape, and packaging to Vortioxetine, but without active ingredients 
Intervention  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 increment to 20 mg after 10 days. Tab. Vortioxetine 5 mg will also be initiated on day 1 as an add-on, with a planned increase to 10 mg at the end of 10 days. Thus, the patients in the intervention group will receive Tab. Escitalopram 20 mg and Tab. Vortioxetine 10 mg daily for the remaining duration of the study. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  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.  
 
ExclusionCriteria 
Details  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
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Reduction in the OCD symptoms measured by YBOCS (Yale Brown Obsessive Compulsive Scale).   Follow-up assessments of all participants will be conducted at 4 weeks, 8 weeks and 12 weeks from their recruitment 
 
Secondary Outcome  
Outcome  TimePoints 
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) 		 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
 		 Follow-up assessments of all participants will be conducted at 4 weeks, 8 weeks and 12 weeks from their recruitment 
 
Target Sample Size   Total Sample Size="114"
Sample Size from India="114" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   01/01/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details
Modification(s)  		 N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  		 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. 
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