A clinical study to evaluate the effect of L-methyl folate on depressive symptoms in patients with major depressive disorder.

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 - NIL

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/10/096368

Enrollment

Registered

2025-10-22

Start date

Unknown

Completion date

Unknown

Last updated

2025-11-17

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: L-methyl folate 15mg: L-methyl folate 15mg will be given in the morning with food for 60 days. Control Intervention1: Placebo: Glucose tablet identical in shape, size and color to L-met

Eligibility

Inclusion criteria

Inclusion criteria: Patients on a stable dose (no change in dose) of antidepressants for 4 weeks. Patients willing to participate and give consent

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
Reduction in depressive symptoms as assessed by Hamilton Depression Rating Scale (HAMD)Timepoint: At baseline and 60 days	—

Secondary

Measure	Time frame
Reduction in depressive symptoms as assessed by Montgomery Asberg Depression Rating Scale (MADRS)Timepoint: At baseline and 60 days;To evaluate the change in serum BDNF after 60 days of add-on L-methyl folate therapy.Timepoint: At baseline and 60 days;To evaluate the change in serum SAM levels after 60 days of add-on L-methyl folate therapy.Timepoint: 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.Timepoint: At baseline and 60 days	—

Measure

Time frame

Reduction in depressive symptoms as assessed by Montgomery Asberg Depression Rating Scale (MADRS)Timepoint: At baseline and 60 days;To evaluate the change in serum BDNF after 60 days of add-on L-methyl folate therapy.Timepoint: At baseline and 60 days;To evaluate the change in serum SAM levels after 60 days of add-on L-methyl folate therapy.Timepoint: 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.Timepoint: At baseline and 60 days

—

Countries

India

Contacts

Public ContactDr Meghna Kaul

All India Institute of Medical Sciences, New Delhi

reetakh@gmail.com9711204141

Outcome results

None listed

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