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CTRI Number  CTRI/2023/12/060774 [Registered on: 26/12/2023] Trial Registered Prospectively
Last Modified On: 18/12/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To compare vortioxetine and escitalopram in the management of major depressive disorder.  
Scientific Title of Study   A comparative study of vortioxetine and escitalopram on efficacy, tolerability and effects on metabolic parameters in the management of major depressive disorder in a 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  Suravi Das 
Designation  Junior resident 
Affiliation  Eras lucknow medical college and hospital 
Address  Department of Psychiatry, 5th floor, eras lucknow medical college and hospital, lucknow, uttar pradesh, india, 226003.

Lucknow
UTTAR PRADESH
226003
India 
Phone  9909945124  
Fax    
Email  Drsuravidas@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Aleem Siddiqui 
Designation  Professor 
Affiliation  Eras lucknow medical college and hospital 
Address  Department of Psychiatry, 5th floor, eras lucknow medical college and hospital, lucknow, uttar pradesh, india, 226003.

Lucknow
UTTAR PRADESH
226003
India 
Phone  7607358897  
Fax    
Email  docaleem@gmail.com  
 
Details of Contact Person
Public Query  
Name  Suravi Das 
Designation  Junior resident 
Affiliation  Eras lucknow medical college and hospital 
Address  Department of Psychiatry, 5th floor, eras lucknow medical college and hospital, lucknow, uttar pradesh, india, 226003.

Lucknow
UTTAR PRADESH
226003
India 
Phone  9909945124  
Fax    
Email  drsuravidas@gmail.com  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  Dr Suravi Das 
Address  Eras lucknow medical college and hospital 
Type of Sponsor  Other [Self] 
 
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 Suravi das  Eras lucknow medical college and hospital  Opd, 1st floor, eras lucknow medical college and hospital, lucknow, uttar pradesh, india, 226003.
Lucknow
UTTAR PRADESH 		 9909945124

Drsuravidas@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Eras Lucknow medical college  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  18 to 45 years of age group, diagnosed as a case of major depressive disorder according to icd 10 criteria.  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Subjects diagnosed as major depressive disorder treated with tablet escitalopram  escitalopram 10 mg orally once at night and followed up on baseline, week 4th and week 12th, benzodiazepines maybe added 
Intervention  Subjects diagnosed as major depressive disorder treated with tablet vortioxetine  tablet vortioxetine 10 mg once at night and will be followed up on baseline, week 4th and week 12th 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  18-45 years of male and female, diagnosed as case of major depressive disorder, not been treated for the index episode. 
 
ExclusionCriteria 
Details  Subjects with comorbid psychiatric disorder except for the comorbid anxiety symptoms and tobacco use, known case of diabetes or hypertension or dyslipidemia or hyperthyroidism, hypothyroidism, with medical or surgical condition that affect his or her locomotor capabilities, pregnancy and lactating female. 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess the efficacy, tolerability and metabolic parameters on subjects treated with vortioxetine versus escitalopram in the management of major depressive disorder.  At baseline, week 4th and week 12th 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the treatment adverse effects responsible for intolerance of vortioxetine and escitalopram by using the anti depressant side effect checklist.   Baseline, week 4, week 12. 
To study the association of efficacy and tolerability of vortioxetine and escitalopram in the management of major depressive disorder.  Baseline, week 4, week 12. 
 
Target Sample Size   Total Sample Size="74"
Sample Size from India="74" 
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   Post Marketing Surveillance 
Date of First Enrollment (India)   29/12/2023 
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="2"
Months="0"
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 - NO
Brief Summary  

Vortioxetine demonstrates similar efficacy to that observed for duloxetine, escitalopram, levomilnacipran, sertraline, venlafaxine, and vilazodone, however overall tolerability as measured by discontinuation because of an adverse event differs. Vortioxetine is 5.1 times more likely to be associated with response than discontinuation because of an adverse event when compared to placebo. vortioxetine has proven to be efficacious in the treatment of MDD in the majority of trials, whilst also showing good tolerability 2  Besides effective management of depressive symptoms, vortioxetine has properties that may be beneficial as it enhances cognitive functions. The various aspects of vortioxetine and escitalopram on metabolic parameters and tolerability profile in the management of major depressive disorder is relatively under researched entity in developing countries. 5

Hence the  metabolic parameters and tolerability profile of vortioxetine and escitalopram in Indian patients could be delineated by results of present study, which may add to existing evidences.

 
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