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CTRI Number  CTRI/2025/10/096368 [Registered on: 22/10/2025] Trial Registered Prospectively
Last Modified On: 21/10/2025
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 evaluate the effect of L-methyl folate on depressive symptoms in patients with major depressive disorder. 
Scientific Title of Study   Effect of L Methyl Folate as an Add on Antidepressant Therapy in Patients with Major Depressive Disorder in Indian Population: A Randomized, Double Blind, Placebo Controlled Study 
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 Meghna Kaul 
Designation  Junior Resident Doctor 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Room 4008, Department of Pharmacology, 4th floor, Teaching Block, All India Institute of Medical Sciences, New Delhi

South
DELHI
110029
India 
Phone  8383061722  
Fax    
Email  meghnakaul14@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr KH Reeta 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Room 4029, Department of Pharmacology, 4th floor, Teaching Block, All India Institute of Medical Sciences, New Delhi

South
DELHI
110029
India 
Phone  9711204141  
Fax    
Email  reetakh@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Meghna Kaul 
Designation  Junior Resident Doctor 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Room 4008, Department of Pharmacology, 4th floor, Teaching Block, All India Institute of Medical Sciences, New Delhi

South
DELHI
110029
India 
Phone  8383061722  
Fax    
Email  meghnakaul14@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, Ansari Nagar East, New Delhi-110029, India 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences, New Delhi 
Address  All India Institute of Medical Sciences, Ansari Nagar East, New Delhi-110029, India 
Type of Sponsor  Research institution and hospital 
 
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 Meghna Kaul  All India Institute of Medical Sciences, New Delhi  Room no 1-24, 2nd floor, Department of Psychiatry, AIIMS RAK OPD, New Delhi
South
DELHI 		 8383061722

meghnakaul14@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F329||Major depressive disorder, singleepisode, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  L-methyl folate 15mg  L-methyl folate 15mg will be given in the morning with food for 60 days. 
Comparator Agent  Placebo  Glucose tablet identical in shape, size and color to L-methyl folate 15mg in the morning with food for 60 days. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients on a stable dose (no change in dose) of antidepressants for 4 weeks.
Patients willing to participate and give consent
 
 
ExclusionCriteria 
Details  Patients with comorbid psychiatric or neurological disorders and substance use disorders except nicotine replacement therapy
Patients with unstable medical illnesses or any active malignancy.
Patients with folate or vitamin B12 deficiency.
Patients on methotrexate or other antifolate drugs or antiepileptics.
Patients taking folate supplements more than 400 mcg/day or vitamin B12 more than 6 mcg/ day.
Pregnancy or lactation or expecting to get pregnant during the treatment.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Reduction in depressive symptoms as assessed by Hamilton Depression Rating Scale (HAMD)  At baseline and 60 days 
 
Secondary Outcome  
Outcome  TimePoints 
Reduction in depressive symptoms as assessed by Montgomery Asberg Depression Rating Scale (MADRS)   At baseline and 60 days 
To evaluate the change in serum BDNF after 60 days of add-on L-methyl folate therapy.  At baseline and 60 days 
To evaluate the change in serum SAM levels after 60 days of add-on L-methyl folate therapy.  At baseline and 60 days 
To evaluate the change in serum folate and Vit B12 levels after 60 days add-on L-methyl folate therapy.  At baseline and 60 days 
 
Target Sample Size   Total Sample Size="84"
Sample Size from India="84" 
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 2/ Phase 3 
Date of First Enrollment (India)   03/11/2025 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   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   This study will use a prospective, randomized, double-blind, placebo-controlled design to investigate the effects of add-on L-methyl folate therapy over 60 days on patients with major depressive disorder (MDD). The primary aim is to assess changes in depressive symptoms using the Hamilton Depression Rating Scale (HAMD). Secondary objectives include evaluating changes in serum BDNF levels, changes in serum SAM levels, changes in serum folate and Vitamin B12 levels and the Montgomery–Asberg Depression Rating Scale (MADRS). Participants clinically diagnosed with major depressive disorder and on stable antidepressant therapy for at least 4 weeks will be screened in the psychiatry outpatient department at AIIMS, New Delhi. Eligible participants meeting the inclusion criteria will be randomly assigned to the treatment group, receiving L-methyl folate 15 mg, or the placebo group, receiving a matching placebo. Both groups will continue their ongoing antidepressant regimen for 60 days. At enrollment, demographic data, depression scores, and antidepressant treatment-related data will be collected. Blood samples will be taken to measure depression-related markers (BDNF, SAM, folate and vitamin B12). After 60 days of supplementation, all baseline parameters will be reassessed. Changes in depression scores from baseline to post-supplementation will be calculated and presented as mean (SD). Any adverse events during the intervention will be monitored and reported to the corresponding authorities. 
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