| CTRI Number |
CTRI/2022/01/039469 [Registered on: 17/01/2022] Trial Registered Prospectively |
| Last Modified On: |
13/01/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A clinical study to assess the effect of riboflavin supplementation with antidepressant treatment in patients with major depression |
|
Scientific Title of Study
|
A randomized controlled trial to assess the effect of riboflavin supplementation with antidepressant treatment in persons with major depressive disorder. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sudhir Chandra Sarangi |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Room no. 5009, Convergence block, Department of Pharmacology, AIIMS, New Delhi-110029
New Delhi
DELHI
110029
India |
| Phone |
8518881757 |
| Fax |
|
| Email |
scsarangi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sudhir Chandra Sarangi |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Room no. 5009, Convergence block, Department of Pharmacology, AIIMS, New Delhi-110029
New Delhi
DELHI
110029
India |
| Phone |
8518881757 |
| Fax |
|
| Email |
scsarangi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Deeksha Sharma |
| Designation |
PhD Scholar |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Lab-5002, Convergence block, Department of pharmacology, AIIMS, New Delhi-110029
New Delhi
DELHI
110029
India |
| Phone |
9311819629 |
| Fax |
|
| Email |
deikshasharma19@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India institute of Medical Sciences, New Delhi-110029 |
| Project |
|
|
Primary Sponsor
|
| Name |
This has been submitted to DST for funding |
| Address |
DST, New Delhi |
| Type of Sponsor |
Government funding agency |
|
|
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 |
| Prof Rajesh Sagar |
All India Institute of Medical Sciences, New Delhi |
Room no. 101, 1st floor, Psychiatry Department, New RAK OPD, AIIMS, New Delhi
South
DELHI |
011-26953644
rsagar29@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, AIIMS, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
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 |
Matching Placebo |
Dose: Maching with riboflavin treatment
Route of administration: Oral
Frequency: Daily basis for 3 months
This will be administered along with prescribed/ongoing antidepressants treatment. |
| Intervention |
Riboflavin |
Dose: 30 mg/day
Route of administration: Oral
Frequency: Daily basis for 3 months
This will be administered along with prescribed/ongoing antidepressants treatment. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Subject of age 18-55 years of either gender.
Patients of MDD diagnosed clinically who have not started /within 15 days of antidepressant treatment
Patients who are prescribed any of the antidepressants (SSRI/SNRI) as monotherapy by the psychiatrist
Patients who can read and understand.
Patients who are willing to participate and give consent.
|
|
| ExclusionCriteria |
| Details |
Pregnant or seeking pregnancy, lactating women
Patients suffering from any chronic disease like cardiac diseases, respiratory diseases, liver disease, malignancy, peptic ulcer etc, which are known to affect inflammatory or neurodegenerative markers.
Associated neurological diseases other than depression
Progressive brain diseases like alzheimers disease, parkinsons disease, multiple sclerosis.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the effect of 3 months riboflavin supplementation with antidepressants (SSRI/SNRI) treatment in patients of Indian origin with major depressive disorder (MDD) on depression severity as assessed by HDRS score. |
3 Years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the expression of the identified proteins/genetic biomarkers levels (BDNF, SLC6A4, HTR1A, HTR1B, IL11) in Indian subjects with MDD (before and after riboflavin intervention) vs. healthy control. |
3 Years |
| To assess the effect of riboflavin supplementation with antidepressants (SSRI/SNRI) treatment on the oxidative stress (total antioxidant capacity) and safety parameters (renal function test, liver function test and complete blood count). |
3 Years |
| To assess the effect of riboflavin supplementation with antidepressants (SSRI/SNRI) treatment on the quality of life as assessed by HRQoL and social cognition score assessed by SOCRATIS. |
3 Years |
| To correlate change in treatment response (HDRS score) with the change in identified proteins/genetic biomarkers levels, and oxidative stress. |
3 Years |
|
|
Target Sample Size
|
Total Sample Size="124"
Sample Size from India="124"
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)
|
01/02/2022 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This
study aims to find out the correlation of treatment response with gene
expression and DNA methylation signatures in persons with major depressive
disorder and also to investigate the potential of riboflavin supplementation
with antidepressants treatment to alter these, which will lead to improved
efficacy, tolerability and ultimately better quality of life. This will be a
double-blind placebo-controlled trial and will be conducted upon patients with
MDD. Patients of MDD diagnosed clinically who have not started /within 15 days
of antidepressant treatment will be screened in psychiatry OPD, AIIMS, New
Delhi and those meeting the inclusion criteria will be enrolled for the study.
They will be randomly assigned into two groups (treatment or placebo group)
where the treatment group will receive supplementation of riboflavin and
placebo group will receive matching placebo as per the dosing schedule of
riboflavin along with the ongoing antidepressants regimen for 3 months.
Patients of both groups will be followed up at 3 months of supplementation and
all parameters assessed in the baseline will be re-evaluated. Any adverse
events during the intervention will be monitored and reported to corresponding
authorities. |