| CTRI Number |
CTRI/2025/09/094893 [Registered on: 16/09/2025] Trial Registered Prospectively |
| Last Modified On: |
29/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Use and adverse effects profile of dextromethorphan-bupropion versus escitalopram in treatment of depression |
|
Scientific Title of Study
|
Effectiveness and safety of Dextromethorphan-bupropion versus Escitalopram in treatment of 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 |
TEJASWI P |
| Designation |
PG RESIDENT |
| Affiliation |
ESIC MEDICAL COLLEGE AND PGIMSR |
| Address |
707 GIRLS PG HOSTEL
ESIC MEDICAL COLLEGE AND PGIMSR
RAJAJINAGAR BENGALURU
KARNATAKA 560010
Girls PG hostel ESI medical college Rajajinagar
Bangalore
KARNATAKA
560010
India |
| Phone |
6361334890 |
| Fax |
|
| Email |
p.tejaswiysr@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr VIJAYAKUMAR A E |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
ESIC MEDICAL COLLEGE AND PGIMSR |
| Address |
ESIC MEDICAL COLLEGE AND PGIMSR
RAJAJINAGAR BENGALURU
KARNATAKA 560010
Bangalore
KARNATAKA
560010
India |
| Phone |
8695032720 |
| Fax |
|
| Email |
aevijay1985@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr VIJAYAKUMAR A E |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
ESIC MEDICAL COLLEGE AND PGIMSR |
| Address |
ESIC MEDICAL COLLEGE AND PGIMSR
RAJAJINAGAR BENGALURU
KARNATAKA 560010
Bangalore
KARNATAKA
560010
India |
| Phone |
8695032720 |
| Fax |
|
| Email |
aevijay1985@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
TEJASWI P |
| Address |
GIRLS PG HOSTEL
ESICMC AND PGIMSR
RAJAJINAGAR BANGALORE
KARNATAKA 560010 |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| TEJASWI P |
ESICMC AND PGIMSR |
RAJAJINAGAR
BANGALORE
KARNATAKA 560010
Bangalore
KARNATAKA |
6361334890
p.tejaswiysr@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ESICMC PGIMSR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F321||Major depressive disorder, singleepisode, moderate, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
DRUG |
DEXTROMETHORPHAN BUPROPION |
| Comparator Agent |
DRUG |
ESCITALOPRAM |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients willing to give written informed consent
2 Newly diagnosed patients with major depressive disorder of either sex aged between 18 and 65 years and a current episode of major depressive
disorder
3 Diagnosis will be made based on DSM 5 criteria
4 A minimum score of more than or equal to 25 on Montgomery-Asberg depression rating scale MADRS
5 Minimum score of more than or equal to 4 on clinical global impression severity scale CGI S |
|
| ExclusionCriteria |
| Details |
1 Pregnant or lactating females
2 Patients with medical conditions like hepatic or renal failure
3 Past history of any cardiac disease
4 History of bipolar disorder
5 History of panic disorder
6 History of obsessive compulsive disorder
7 History of treatment resistance depression defined as having at least two failed adequate antidepressants treatments in current major
depressive episode
8 History of psychotic disorder
9 Clinically risk of suicide assessed by C SSRS
10 History of seizures
11 Patients on treatment with any other drugs which are CYP2D6 inducers or inhibitors
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
The primary efficacy variable will be the change in MADRS total score
from baseline to week 6 |
6 WEEKS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 Reduction more than or equal to 50% from baseline in MADRAS total score known as clinical
response
2 MADRS total score less than or equal to 10 known as clinical remission
3 Score on clinical global impression severity scale
4 Score on clinical global impression improvement scale
5 Quick inventory of depression symptomology score known as QIDS SR score |
6 weeks |
|
|
Target Sample Size
|
Total Sample Size="86"
Sample Size from India="86"
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)
|
30/09/2025 |
| 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="1"
Months="3"
Days="5" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
Modification(s)
|
This a prospective interventional RCT to be conducted at ESICMC and PGIMSR to know the effectiveness and safety of dextromethorphan bupropion combination versus escitalopram in treatment of major depressive disorder Dextromethorphan bupropion combination treatment has an additional advantage of less side effects and faster symptomatic relief in depression patients when compared to escitalopram so i would like to do study on this drug to know its effectiveness and safety profile for better treatment and benefit of patients
29 APRIL 2026 This a prospective interventional RCT to be conducted at ESICMC and PGIMSR to know the effectiveness and safety of dextromethorphan bupropion combination versus escitalopram in treatment of major depressive disorder As of 29 April 2026 total of 32 patients have been recruited into the study 14 into dextromethorphan bupropion combination group and 18 into escitalopram group 6 weeks of follow up is being done to all the patients currently open to recruitment of new patients into the study |