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The effect of adding folic acid to the therapeutic diet of patients with mania

A comparative effect of adding folic acid to the therapeutic diet of patients with mania

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2013031612825N1
Enrollment
60
Registered
2014-07-09
Start date
2013-04-21
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

mania. Other degenerative diseases of the nervous system

Interventions

Intervention 1: Intervention group: Adding folic acid to therapeutic regime, in the form of 5 mg pill, once daily, for 4 months. Intervention 2: Control group: Adding placebo to the therapeutic regime
Placebo
Treatment - Drugs
Intervention group: Adding folic acid to therapeutic regime, in the form of 5 mg pill, once daily, for 4 months.
Control group: Adding placebo to the therapeutic regime ( sodium valproate), in the form of a pill, once daily, for 4 months.

Sponsors

Kermanshah University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: having diagnosis of  BD type 1,2 (DSM-IV-TR); age> 18 years. Exclusion criteria: mental retardation (IQ<70); pervasive developmental disorders; patients need ECT or physical controlling; contraindication to use of folic acid and folate dependent tumors; pregnancy; substance abuse or dependency since 3 months ago; risk of suicide which needs preventive interventions; weight lower than 30 kg; schizophrenia; medical or neurological disorders ( epilepsy and other seizure disorders); chronic gastrointestinal disorders; allergy to folic acid; renal disorders; use of supplements such as calcium, and D and B vitamins; chronic infection; anemia.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
To measure and compare the response to treatment in study and control groups based on YMRS scale. Timepoint: After two weeks, one month, two months, three months. Method of measurement: by using Young Mania Rating Scale.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMaryam Pashabadi

Member of Student Research Committee, Kermanshah University of Medical Sciences

maryamflower@yahoo.com+98 83 1432 2356

Outcome results

None listed

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