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CTRI Number  CTRI/2024/04/066519 [Registered on: 30/04/2024] Trial Registered Prospectively
Last Modified On: 26/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Exploration of efficacy and safety of participants exposed to Vortioxetine and Escitalopram for Major Depressive order patients. 
Scientific Title of Study   A Comparative Study of Efficacy and Safety of Vortioxetine with Escitalopram in Patients of Major Depressive Disorder at Tertiary Care Hospital 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr ARAVIND MANOJ KUMAR R 
Designation  Junior Resident 
Affiliation  Vilasrao Deshmukh Government Medical College 
Address  Department of Pharmacology, Vilasrao Deshmukh Government Medical College, Near Rajasthani Marwadi School, Government Medical College Campus,

Latur
MAHARASHTRA
413512
India 
Phone  9566203450  
Fax    
Email  aravind021084@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vinod Shivajirao Deshmukh 
Designation  Associate Professor 
Affiliation  Vilasrao Deshmukh Government Medical College 
Address  Department of Pharmacology, Vilasrao Deshmukh Government Medical College, Near Rajasthani Marwadi School, Government Medical College Campus,

Latur
MAHARASHTRA
413512
India 
Phone  9405102432  
Fax    
Email  vinod_deshmukh88@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Vinod Shivajirao Deshmukh 
Designation  Associate Professor 
Affiliation  Vilasrao Deshmukh Government Medical College 
Address  Department of Pharmacology, Vilasrao Deshmukh Government Medical College, Near Rajasthani Marwadi School, Government Medical College Campus,

Latur
MAHARASHTRA
413512
India 
Phone  9405102432  
Fax    
Email  vinod_deshmukh88@yahoo.com  
 
Source of Monetary or Material Support  
Vilasrao Deshmukh Government Medical College Near Rajasthani Marwadi school Government medical college campus Latur 413512 Maharashtra India 
 
Primary Sponsor  
Name  nil 
Address  nil 
Type of Sponsor  Other [nil] 
 
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 Aravind Manoj Kumar R  Vilasrao Deshmukh Government Medical College  Room No 8, Outpatient Department of Psychiatry, Super specialty Block, Near Rajasthani Marwadi School, Government Medical College Campus
Latur
MAHARASHTRA 		 9566203450

aravind021084@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Department of Pharmacology,Vilasrao Deshmuk Government Medical College,Latur, MH  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F339||Major depressive disorder, recurrent, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  vortioxetine and Escitalopram   oral route of administration dosage vortioxetine 10mg,escitalopram 5mg frequency at 2nd,4th,8th and 12th week 
Comparator Agent  vortioxetine with escitalopram  vortioxetine 10mg escitalopram 5mg efficacy and safety assessed using different scales at 2nd,4th,8th and 12th weeks 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1)Adult Patients (18-65 years old) diagnosed with MDD based on DSM-5 criteria.
2) Patients Presenting to the tertiary Care Hospital outpatient Department with moderate to severe symptoms.
3) Willingness to Provide informed consent for participation in the study. 
 
ExclusionCriteria 
Details  •Patients with a history of bipolar disorder, psychotic disorder, or substance abuse within the past six months.
•Concurrent use of other antidepressants or psychotropic medications.
•Patients with previous depression resistant to antidepressants and those who had taken treatment with ECT in previous 3 months or formal psychotherapy within 1 month.
•Pregnancy or lactation.
•Patients with drug intake for psychosis or anxiety.
•Any history of allergy to the drugs. 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Dates of Birth or day of the Week 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
The Proportion of Participants achieving HAM D score of 7 at 12 weeks with vortioxetine vs escitalopram  Till 12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
1 To assess the safety & tolerability profiles of vortioxetine & escitalopram.
2 To explore any demographic or clinical factors that may influence treatment response.
 		 till 12 weeks 
 
Target Sample Size   Total Sample Size="88"
Sample Size from India="88" 
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 4 
Date of First Enrollment (India)   20/05/2024 
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)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
Objective: To compare efficacy and safety of Vortioxetine with Escitalopram in treatment of major depressive disorder (MDD).
Methods: A prospective, randomized, active-controlled, and parallel–group comparative open label study will be conducted among 88 patients of MDD attending psychiatry OPD of a tertiary care center. They were divided into control and experimental groups receiving Escitalopram and Vortioxetine respectively. Hamilton depression rating scale (HAM-D), Hamilton anxiety rating scale (HAM-A), Montgomery-Asberg depression rating scale (MADRS), clinical global impression improvement (CGI-I), and CGI-severity (CGI-S) scores were assessed at the end of 1st, 2nd, 4th, and 12th weeks in both the groups.
This comparative study examines the efficacy and safety of two commonly prescribed antidepressants, Vortioxetine and Escitalopram, in treating Major Depressive Disorder (MDD). Conducted at a Tertiary Care Hospital, the research aims to provide insights into the relative effectiveness and tolerability of these medications. Through a rigorous analysis of patient outcomes, including symptom reduction, side effects, and overall treatment adherence, the study seeks to offer valuable guidance to clinicians in selecting the most appropriate pharmacological intervention for individuals with MDD. By comparing the benefits and risks of Vortioxetine and Escitalopram, this research contributes to optimizing therapeutic approaches for managing depression in clinical practice.
 
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