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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: CTRI
Last refreshed on: 24 November 2021
Main ID:  CTRI/2017/03/008255
Date of registration: 30-03-2017
Prospective Registration: No
Primary sponsor: Director Principal Government medical college and hospital Chandigarh
Public title: Use of bioavailable form of Folic acid for Treatment of Depression
Scientific title: Role of L-Methylfolate in Treatment of Depression
Date of first enrolment: 01-01-2015
Target sample size: 67
Recruitment status: Completed
URL:  http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=17929
Study type:  Interventional
Study design:  Randomized, Parallel Group, Active Controlled Trial
Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Other Blinding and masking:Open Label
 
Phase:  N/A
Countries of recruitment
India
Contacts
Name: Dr BS Chavan   
Address:  HOD Room Psychiatry Office Department of Psychiatry D-Block Level V Government Medical College and Hospital Sector 32 Chandigarh 160032 Chandigarh, CHANDIGARH India
Telephone: 9646121611
Email: drchavanbs@gmail.com
Affiliation:  Government medical college and hospital, sector 32, Chandigarh
Name: Sushmita Bhattacharya   
Address:  Room number 4215-4217 Psychiatry OPD Department of Psychiatry B-Block, Level IV Government Medical College and Hospital 160032 Chandigarh, CHANDIGARH India
Telephone: 9646121611
Email: drchavanbs@gmail.com
Affiliation:  Government medical college and hospital, sector 32, Chandigarh
Key inclusion & exclusion criteria
Inclusion criteria: 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.


Exclusion criteria: 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, Alzheimerâ??s disease, or Parkinsonâ??s disease.



Age minimum:
Age maximum:
Gender:
Health Condition(s) or Problem(s) studied
Health Condition 1: null- Depression
Intervention(s)
Intervention1: 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
Control Intervention1: Escitalopram: Antidepressant
Escitalopram: 10-20mg once daily oral dosage.
Total duration of therapy: 8 weeks
Primary Outcome(s)
Change in HAM-D scoreTimepoint: 0,2,4,6,8 weeks
Secondary Outcome(s)
Change in quality of life and functioningTimepoint: 0,4,8 weeks
Secondary ID(s)
NIL
Source(s) of Monetary Support
Director Principal, Administrative section, B-Block, Government Medical College and Hospital, sector 32, Chandigarh
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date: 08/12/2014
Contact:
Institutional Ethics Committee (GMCH, Chandigarh)
Results
Results available:
Date Posted:
Date Completed:
URL:
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