| CTRI Number |
CTRI/2024/09/073493 [Registered on: 05/09/2024] Trial Registered Prospectively |
| Last Modified On: |
07/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to compare the effect of a new medicine (Bupropion-Dextromethorphan) with that of an old medicine (Sertraline) in improving depressive symptoms in persons suffering from depression. |
|
Scientific Title of Study
|
Efficacy of Bupropion-Dextromethorphan fixed dose combination versus Sertraline in major depressive disorder patients: a non-inferiority randomised controlled trial |
| 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 Vikas Maharshi |
| Designation |
Associate Professor |
| Affiliation |
AIIMS, Patna |
| Address |
Department of Pharmacology, All India Institute of Medical Sciences, Patna
Patna
BIHAR
801507
India |
| Phone |
8368035562 |
| Fax |
|
| Email |
vikas.maharshi81@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vikas Maharshi |
| Designation |
Associate Professor |
| Affiliation |
AIIMS, Patna |
| Address |
Department of Pharmacology, All India Institute of Medical Sciences, Patna
BIHAR
801507
India |
| Phone |
8368035562 |
| Fax |
|
| Email |
vikas.maharshi81@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vikas Maharshi |
| Designation |
Associate Professor |
| Affiliation |
AIIMS, Patna |
| Address |
Department of Pharmacology, All India Institute of Medical Sciences, Patna
BIHAR
801507
India |
| Phone |
8368035562 |
| Fax |
|
| Email |
vikas.maharshi81@gmail.com |
|
|
Source of Monetary or Material Support
|
| Research division, All India Institute of Medical Sciences, Patna, Bihar. PIN code 801507 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences Patna |
| Address |
Research Division, All India Institute of Medical Sciences, Patna, Bihar. PIN code 801507 |
| Type of Sponsor |
Other [Government Medical College cu, Hospital and Research Institution] |
|
|
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 |
| Dr Vikas Maharshi |
All India Institute of Medical Sciences, Patna |
Department of Pharmacology and Department of Psychiatry
Patna
BIHAR |
8368035562
vikas.maharshi81@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, AIIMS, Patna |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F322||Major depressive disorder, singleepisode, severe without psychotic features, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bupropion (105 mg) Dextromethorphan (45 mg) fixed dose combination |
105 mg/45 mg drug per oral once daily for initial three days followed by twice daily for 6 weeks |
| Comparator Agent |
Sertraline (50-200 mg) |
50-200 mg tablet per oral once/twice daily for for 6 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Falling into age range of 18-65 years.
2. Confirmed MDD (DSM-5 criteria) patient experiencing a major depressive episode for at least 4 weeks.
3. Baseline MADRS score of 20 or higher, corresponding to moderate or greater severity and CGI-S of 4 or higher.
4. Ability to provide informed consent
|
|
| ExclusionCriteria |
| Details |
1. Patients with treatment resistant depression (at least two failed treatments in the current depressive episode).
2. Patients receiving treatment for Psychotic Disorder, Bipolar Disorder, Panic Disorder, Obsessive compulsive Disorder or Seizure Disorder.
3. Current Alcohol or substance use or dependence within the past 12 months.
4. Any patient with high risk of suicide.
5. Medical conditions: presence of severe medical or neurological conditions.
6. Pregnant woman or Breastfeeding mother.
7. Allergy to any of the components of study drug(s).
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of participants responding based on a predefined change in MADRS score at 6 weeks of therapy. |
6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary outcomes
Change in MADRS score at 6 weeks of therapy
Time to achieve 50% reduction in MADRS score
Change in score/ Proportion of participants responding clinically based on a predefined criteria of change in score of CGI-S
Improvement in disease condition based on CGI-I
Number of adverse events during study follow-up
Proportion of participants responding clinically based on a predefined criteria of change in score of Q-LES-QSF |
6 weeks |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
15/10/2024 |
| 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="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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - Data may be asked from corresponding author and the data may be shared on a reasonable request.
- For how long will this data be available start date provided 31-12-2026 and end date provided 30-12-2031?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Approval from Institute Ethics Committee will be obtained before commencement of this study. Study protocol will be registered in clinical trial registry of India. Informed consent will be obtained from all the volunteers, followed by screening for eligibility. Participants will be required to attend six visits over a 6 week trial period followed by one week safety assessment. Procedures for the ingestion of study drugs will be consistent between the trial groups. Participants will be called for follow-up at weeks 1, 2, 4, 6 and 7. Improvement in scores will be assessed through various scales at follow-up visits. Study will be conducted following principles of Declaration of Helsinki and good clinical practice guidelines. |