FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2026/01/100712 [Registered on: 09/01/2026] Trial Registered Prospectively
Last Modified On: 08/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   Study to compare Dextromethorphan-Bupropion and Desvenlafaxine in Patients with Major Depressive Disorder 
Scientific Title of Study   Prospective, Observational study on Efficacy and Safety of Dextromethorphan-Bupropion in Comparison to Desvenlafaxine in Patients with Major Depressive Disorder 
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 Thakur Sakshi Maliksingh 
Designation  1st year PG resident  
Affiliation  Dr. M.K Shah medical college and research centre 
Address  Psychiatry OPD, first floor ,SMS multispecialty hospital,chandkheda, Ahmedabad 382424

Ahmadabad
GUJARAT
382424
India 
Phone  9099573443  
Fax    
Email  sakshibundela225@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vishal Patel 
Designation  professor and hod 
Affiliation  Dr. M.K Shah medical college and research centre 
Address  Psychiatry OPD, first floor ,SMS multispecialty hospital,chandkheda, Ahmedabad 382424

Ahmadabad
GUJARAT
382424
India 
Phone  9228249767  
Fax    
Email  hod_psychiatry@mkshahmcrc.com  
 
Details of Contact Person
Public Query  
Name  Dr Thakur Sakshi Maliksingh 
Designation  1st year PG resident  
Affiliation  Dr. M.K Shah medical college and research centre 
Address  Psychiatry OPD, first floor ,SMS multispecialty hospital,chandkheda, Ahmedabad 382424


GUJARAT
382424
India 
Phone  9099573443  
Fax    
Email  sakshibundela225@gmail.com  
 
Source of Monetary or Material Support  
nil 
 
Primary Sponsor  
Name  SMS multispecialty hospital  
Address  SMS multispecialty hospital ,near tapovan circle,gandhinagar-visat highway chandkheda ,Ahmedabad 382424 
Type of Sponsor  Private 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 
Dr Sakshi Thakur  SMS multispeciality hospital  Block B,1st floor,Psychiatry OPD,sms multispeciality hospital,near tapovan circle ,chandkheda , ahmedabad 382424
Ahmadabad
GUJARAT 		 9099573443

sakshibundela225@gmail.com 
 
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: F321||Major depressive disorder, singleepisode, moderate,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Desvenlafaxine  Desvenlafaxine (50mg/100mg) per oral for 12weeks 
Intervention  Dextromethorphan-Bupropion  Dextromethorphan-Bupropion (45mg-105mg) per oral for 12weeks 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1 Patients with age of 18 to 60 years.
2 Patients with first episode of Major Depressive Disorder
3 Scores of MADRS more than 19.
4 Patients with MDD who will be prescribed Desvenlafaxine or Dextromethorphan-Bupropion.
5 The participants who will provide written informed consent
 
 
ExclusionCriteria 
Details  1. Non-consent for participation in the study
2.Age less than 18 years and more than 60 year.
3. Primary diagnosis of any ANXIETY DISORDER (GAD), SOCIAL ANXIETY DISORDER, PANIC DISORDER, PTSD, SUBSTANCE USE DISORDER, BIPOLAR DISORDER, current or past comorbid diagnosis of SCHIZOPHRENIA, SCHIZOAFFECTIVE DISORDER, DELUSIONAL DISORDER, PSYCHOTIC DISORDER not otherwise specified, ORGANIC MENTAL DISORDER including DEMENTIA, EATING DISORDER, OCD, SEIZURE DISORDER, comorbid serious comorbid condition hypo or hyperthyroidism.
4.Patients with Risk for suicide
5.Patients who are not on drug Dextromethorphan- Bupropion or drug Desvenlafaxine.
6. Patient with clinically significant condition, pulmonary, central nervous system (stroke, dementia), uncontrolled hypertension and Diabetes at screening, renal disease
7.Patients with cardiac condition in the last six months (including but not limited to the, myocardial infarction, moderate to severe congestive heart failure, congenital prolongation of QT, symptomatic bradycardia, Bazett’s corrected QT (more than 460msec if male or more than 470msec if female)

8. Pregnant or lactating women.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To study safety and efficacy and Safety of Dextromethorphan-Bupropion in Comparison to Desvenlafaxine in Patients with Major Depressive Disorder  baseline, 2nd, 4th ,6th and 12th week. 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="128"
Sample Size from India="128" 
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   N/A 
Date of First Enrollment (India)   20/01/2026 
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 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  

 This is prospective observational study and aim of the study is to compare safety and efficacy of two pharmacological treatments Dextromethorphan-Bupropion and Desvenlafaxine in reducing depressive symptoms in patients with MDD. A total of 128 patients who meets the inclusion criteria and who will provide written informed consent will be recruited for the study. The diagnosis and the drug to be prescribed will be decided by the consultant psychiatrist. Patients who will be prescribed drug Desvenlafaxine & drug Dextromethorphan-Bupropion will be taken for study. Both groups will be observed for 12 weeks and follow up will be taken on 2nd, 4th ,6th and 12th week. The symptoms of depression will be assessed on every follow up to know the efficacy of drug using clinical rating scales Montgomery-Asberg Depression Rating Scale (MADRS), Clinical Global Impression- Improvement Scale CGI-I and safety of drugs will be assessed using Frequency, Intensity and burden of Side effects Rating (FIBSER), Arizona Sexual Experience Scale (ASEX), Antidepressant Side Effect Checklist (ASEC). 

 
Close