Use of bioavailable form of Folic acid for Treatment of Depression

• 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: Sushmita Bhattacharya
• Affiliation: Government medical college and hospital, sector 32, Chandigarh

• Name: Dr BS Chavan
• 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

Ethics review

Status: Approved
Approval date: 08/12/2014
Contact:

Institutional Ethics Committee (GMCH, Chandigarh)