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Effect of Folic acid supplementation on the therapeutic regimen for major depressive disorder

Effect of Folic acid supplementation on response to the standard treatment in patients with major depressive disorder.

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2014082518922N1
Enrollment
90
Registered
2014-12-06
Start date
2013-11-06
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major depression. Depressive episode

Interventions

Intervention 1: Folic acid tablet, one half of 5 mg tablets, once per day for 8 weeks. Intervention 2: Tablets without the active ingredient with the same size and shape of Folic acid tablet, a half t
Treatment - Drugs
Placebo
Folic acid tablet, one half of 5 mg tablets, once per day for 8 weeks
Tablets without the active ingredient with the same size and shape of Folic acid tablet, a half tablet daily, for 8 weeks

Sponsors

Vice Chancellor for research, Kashan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 50 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: To have a definite diagnosis of major depressive disorder according to the DSM-IV-TR criteria; Being between 20 and 50 years old; To get the minimum score of 12 from the BDI 2 scoring system; Having stopped taking any other antidepressant medications since 4 weeks before starting folic acid; Patients who sign the written informed consent after being provided with the detailed information about the study; Not having anemia based on a Complete Blood Count (CBC) test; The absence of pregnancy; No alcohol or substance use in 6 months prior to the study; The absence of manic episodes; The absence of psychotic symptoms; The absence of mental retardation; Depression not due to a general medical condition or substance; The absence of any severe or chronic physical illnesses. Exclusion criteria: Having any acute and severe medical conditions; The incidence of any severe psychiatric disorders (suicidal thoughts, psychotic symptoms, manic phase symptoms, etc.); Failure to follow-up for at least 4 weeks; The concomitant use of other psychotropic drugs; The incidence of severe complications during treatment.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Depression severity. Timepoint: 4, 6 and 8 weeks after starting the treatment. Method of measurement: The Beck Depression Inventory 2nd Edition.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Narges Gholampour

Kashan University of Medical Sciences

gholampour@kaums.ac.ir+98 31 5554 0036

Outcome results

None listed

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