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

• Register: IRCT
• Last refreshed on: 22 February 2018
• Main ID: IRCT2014082518922N1
• Date of registration: 2014-12-06
• Prospective Registration: No
• Primary sponsor: Vice Chancellor for research, Kashan University of Medical Sciences
• Public title: Effect of Folic acid supplementation on the therapeutic regimen for major depressive disorder
• Scientific title: Effect of Folic acid supplementation on response to the standard treatment in patients with major depressive disorder.
• Date of first enrolment: 2013-11-06
• Target sample size: 90
• Recruitment status: Complete
• URL: http://en.irct.ir/trial/17035
• Study type: interventional
• Study design: Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment.
• Phase: 3

Countries of recruitment

Iran (Islamic Republic of)

Contacts

• Name: Dr. Narges Gholampour
• Affiliation: Kashan University of Medical Sciences

• Name: Dr. Narges Gholampour
• Affiliation: Kashan University of Medical Sciences

Key inclusion & exclusion 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:

Age minimum: 20 years
Age maximum: 50 years
Gender: Both

Health Condition(s) or Problem(s) studied

Major depression.
Depressive episode

Depressive episode

Intervention(s)

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 tablet daily, for 8 weeks.

Folic acid tablet, one half of 5 mg tablets, once per day for 8 weeks

Treatment - Drugs

Placebo

Tablets without the active ingredient with the same size and shape of Folic acid tablet, a half tablet daily, for 8 weeks

Primary Outcome(s)

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

Source(s) of Monetary Support

Vice Chancellor for research, Kashan University of Medical Sciences

Ethics review

Status: Approved
Approval date:
Contact:

Kashan University of Medical Sciences