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CTRI Number  CTRI/2025/07/092082 [Registered on: 31/07/2025] Trial Registered Prospectively
Last Modified On: 30/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Which Works Better for Depression? A Study of Escitalopram vs Desvenlafaxine 
Scientific Title of Study   Comparison Of Efficacy and Safety of Escitalopram Versus Desvenlafaxine In Major Depressive Disorder In a Tertiary Care Hospital: A Prospective Randomised Open Label Study.” 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mayank Pande 
Designation  Junior resident 2 
Affiliation  IGGMC Nagpur 
Address  Dept of Pharmacology, IGGMC ,CA Road Nagpur, 440018

Nagpur
MAHARASHTRA
440018
India 
Phone  7265095595  
Fax    
Email  pandema111@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vandana Badar 
Designation  Head and Professor 
Affiliation  IGGMC Nagpur 
Address  Dept. of Pharmacology, IGGMC , CA Road Nagpur,

Nagpur
MAHARASHTRA
440018
India 
Phone  9960031486  
Fax    
Email  drvandanabadar@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Vandana Badar 
Designation  Head and Professor 
Affiliation  IGGMC Nagpur 
Address  Dept. of Pharmacology, IGGMC , CA Road Nagpur,


MAHARASHTRA
440018
India 
Phone  9960031486  
Fax    
Email  drvandanabadar@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  IGGMC Nagpur 
Address  Dept of pharmacology , Indira Gandhi Government Medical College, CA road , Nagpur, Maharastra, India- 440018 
Type of Sponsor  Government medical college 
 
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 
DrMayank Pande  Indira Gandhi Government Medical College ,Nagpur  Dept of pharmacology,3rd floor, A Wing, IGGMC CA Road , Nagpur,440018
Nagpur
MAHARASHTRA 		 7265095595

pandema111@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC INDIRA GANDHI GOVERNMENT MEDICAL COLLEGE NAGPUR  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F329||Major depressive disorder, singleepisode, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Tab Desvenlafaxine 100mg  Tab Desvenlafaxine 100mg HS orally after food for 12 weeks 
Intervention  Tab Escitalopram 10mg   Tab Escitalopram 10mg HS orally after food for 12 weeks. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  · Drug naive patients diagnosed with major depression and started with antidepressants in outpatient of department of psychiatry.
· Patients who are willing to give informed consent.
 
 
ExclusionCriteria 
Details  · Age: LESS THAN 18 AND MORE THAN 60yrs
· Patients with Bipolar depression.
· Patients who are not willing to give informed consent.
· Uncooperative patients 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To compare and assess the efficacy of escitalopram versus Desvenlafaxine in treating major depressive disorder  0,4,8,12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
To compare and assess the safety of escitalopram versus Desvenlafaxine in treating major depressive disorder  0,4,8,12 weeks 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   15/09/2025 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [pandema111@gmail.com].

  6. For how long will this data be available start date provided 01-10-2025 and end date provided 01-10-2030?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This study compares the efficacy and safety of Escitalopram (an SSRI) and Desvenlafaxine (an SNRI) in treating Major Depressive Disorder (MDD) at a tertiary care hospital. It is a prospective, randomized, open-label study involving 100 newly diagnosed, drug-naive MDD patients aged 18–60 years. Patients are assessed at baseline, 4, 8, and 12 weeks using the Hamilton Depression Rating Scale and laboratory investigations. The primary objective is to compare treatment efficacy; the secondary objective is to evaluate safety using WHO causality and Hartwig and Siegel scores. The study adheres to ethical guidelines and has received Institutional Ethics Committee approval. 
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