A clinical study to assess the effect of riboflavin supplementation with antidepressant treatment in patients with major depression

A randomized controlled trial to assess the effect of riboflavin supplementation with antidepressant treatment in persons with major depressive disorder.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/01/039469

Enrollment

124

Registered

2022-01-17

Start date

Unknown

Completion date

Unknown

Last updated

2022-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: F329- Major depressive disorder, singleepisode, unspecified

Interventions

Intervention1: 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. Control

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
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.Timepoint: 3 Years	—

Secondary

Measure	Time frame
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).Timepoint: 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.Timepoint: 3 Years;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.Timepoint: 3 Years;To correlate change in treatment response (HDRS score) with the change in identified proteins/genetic biomarkers levels, and oxidative stress.Timepoint: 3 Years	—

Measure

Time frame

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).Timepoint: 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.Timepoint: 3 Years;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.Timepoint: 3 Years;To correlate change in treatment response (HDRS score) with the change in identified proteins/genetic biomarkers levels, and oxidative stress.Timepoint: 3 Years

—

Countries

India

Contacts

Public ContactDeeksha Sharma

All India Institute of Medical Sciences, New Delhi

scsarangi@gmail.com8518881757

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026