effects of folic acid combination with fluoxetine in treatment of patients with major depressive disorder under age 18

randomized controlled trial folic acid combination with fluoxetine in treatment of patients with major depressive disorder under age 18

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20230619058530N1

Enrollment

Registered

2023-07-20

Start date

2023-07-23

Completion date

Unknown

Last updated

2023-07-25

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

Conditions

major depressive disorder. Major depressive disorder, single episode

Interventions

Intervention 1: Intervention group: folic acid tablet (Folic acid-IRAN DAROO 1MG TAB) with dose 1-5mg daily, once daily orally for 3 month. Intervention 2: Control group: placebo tablet(School of Phar

Eligibility

Sex/Gender

All

Age

6 Years to 18 Years

Inclusion criteria

Inclusion criteria: clinical diagnosis of Major Depressive Disorder according to DSM-5 criteria consent to participate in the study by completing the informed consent form by patient and patient Lack of any history of receiving any anti depressant drug or mood stabilizers during recent 3 month before study lack of history of allergic reaction to drug age between 6-18 years

Exclusion criteria

Exclusion criteria: need to ECT treatment during study any unexpected new physical or mental condition that could change medical care of patient

Design outcomes

Primary

Measure	Time frame
Major depressive disorder. Timepoint: Before intervention and 1,3 months after intervention. Method of measurement: Children Depression Inventory (CDI).;Blood indices(red blood cells, hemoglobin and men corpuscular volume(. Timepoint: Before intervention and 1,3 months after intervention. Method of measurement: Lab kit.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMostafa Haghshenas

Esfahan University of Medical Sciences

haghshenas2005@gmail.com+98 31 3222 2475

Outcome results

None listed

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