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CTRI Number  CTRI/2017/03/008255 [Registered on: 30/03/2017] Trial Registered Retrospectively
Last Modified On: 29/03/2017
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Use of bioavailable form of Folic acid for Treatment of Depression 
Scientific Title of Study   Role of L-Methylfolate in Treatment of Depression 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sushmita Bhattacharya 
Designation  Postgraduate Junior Resident 
Affiliation  Government medical college and hospital, sector 32, Chandigarh 
Address  Room number 4215-4217 Psychiatry OPD Department of Psychiatry B-Block, Level IV Government Medical College and Hospital

Chandigarh
CHANDIGARH
160032
India 
Phone  9988297850  
Fax    
Email  sushmitabhattacharya047@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr BS Chavan 
Designation  Professor and Head (GUIDE) 
Affiliation  Government medical college and hospital, sector 32, Chandigarh 
Address  HOD Room Psychiatry Office Department of Psychiatry D-Block Level V Government Medical College and Hospital Sector 32 Chandigarh

Chandigarh
CHANDIGARH
160032
India 
Phone  9646121611  
Fax    
Email  drchavanbs@gmail.com  
 
Details of Contact Person
Public Query  
Name  Sushmita Bhattacharya 
Designation  Postgraduate Junior Resident 
Affiliation  Government medical college and hospital, sector 32, Chandigarh 
Address  Room number 4215-4217 Psychiatry OPD Department of Psychiatry B-Block, Level IV Government Medical College and Hospital

Chandigarh
CHANDIGARH
160032
India 
Phone  9988297850  
Fax    
Email  sushmitabhattacharya047@gmail.com  
 
Source of Monetary or Material Support  
Director Principal, Administrative section, B-Block, Government Medical College and Hospital, sector 32, Chandigarh 
 
Primary Sponsor  
Name  Director Principal Government medical college and hospital Chandigarh 
Address  Director Principal, Administrative section, B-Block, Government medical college and hospital, Sector 32, Chandigarh 
Type of Sponsor  Government medical college 
 
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 
Sushmita Bhattacharya  Government Medical College and Hospital, Sector 32, Chandigarh  Psychiatry OPD, Room NO 4215-17, Area 42, Department of Psychiatry, B-Block, Level-IV
Chandigarh
CHANDIGARH 		 9988297850

sushmitabhattacharya047@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (GMCH, Chandigarh)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Depression,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Escitalopram  Antidepressant Escitalopram: 10-20mg once daily oral dosage. Total duration of therapy: 8 weeks 
Intervention  L-Methylfolate,Escitalopram  Antidepressant Escitalopram: 10-20mg once daily oral dosage L-Methylfolate: 7.5-15mg once daily oral dosage Total duration of therapy: 8 weeks 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1) Patients with primary diagnosis of moderate to severe depression according to ICD-10 DCR criteria. These patients should be treatment naïve or if receiving treatment should have regular compliance to it for at least 6 weeks and not be responding to the current treatment as defined by response of <50% of global improvement as reported by the patient and the caregivers.
2) Patients having HAM-D score of ≥17, at time of intake which indicates at least moderate degree of depression.
3) Patient and his/her relative willing to give informed consent.
 
 
ExclusionCriteria 
Details  1) Breastfeeding, and pregnant females
2) Having a current serious suicide risk, or psychotic symptoms
3) Unstable medical illness requiring concomitant use of other medication including those medications which are known to have depressogenic effect ( corticosteroids, anti-epileptics, beta-blockers, quinolone class of antibiotics, interferons, anti-neoplastic drugs).
4) Having an active substance use disorder within the past 6 months (in terms of fulfilling criteria for substance-harmful use or substance dependence) except nicotine and caffeine use.
5) Having past history of mania/hypomania (including antidepressant-induced), psychotic symptoms, or seizure disorder.
6) Taking vitamins or dietary supplements containing folate or vitamin B12.
7) Having comorbid diagnosis of intellectual disability, dementia, Alzheimer’s disease, or Parkinson’s disease.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Other 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Change in HAM-D score  0,2,4,6,8 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Change in quality of life and functioning  0,4,8 weeks 
 
Target Sample Size   Total Sample Size="67"
Sample Size from India="67" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/01/2015 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="10"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

There is a neurophysiologic rationale for folate augmentation of antidepressant therapy involving both biochemical and genetic factors. The studies evaluating the effectiveness of L-methylfolate are few and have been mostly conducted on treatment resistant patients. Hence, the number of available trials remains small and heterogeneity between such studies high. The overall review of literature shows scarcity of studies on the role of folate, especially the bioavailable L-methylfolate, at the time of initiation of antidepressant for the treatment of depression. This present study is aimed to compare the efficacy and tolerability of L-methylfolate in the treatment of depression and evaluate the predictors of response to L-methylfolate. 

 
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