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The assessment of folic Acid and vitamin B6 effects in bipolar patients

The assessment of folic Acid and vitamin B6 effects add-in sodium valproate in bipolar mood Disorder in Acute phase of mania

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT201112188106N1
Enrollment
43
Registered
2012-01-14
Start date
2011-04-04
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

Bipolar disorder. Bipolar affective disorder, unspecified

Interventions

Intervention 1: Case group 1: folic acid,oral tab 5mg,once a day,for six weeks. Intervention 2: Case group 2:vitamin B6,oral tab 40mg,towice a day, for six weeks. Intervention 3: Control group:place
Treatment - Drugs
Placebo
Case group 1: folic acid,oral tab 5mg,once a day,for six weeks
Case group 2:vitamin B6,oral tab 40mg,towice a day, for six weeks
Control group:placebo,oral tab,once a day,for six weeks

Sponsors

Mashhad University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria:1)Patients age between 18 to 45 years old according to birth certificate.2)Diagnosis of bipolar mood disorder I with recent episode of mania according to DSM IV TR diagnosis criteria.3)Roling out diagnosis of schizophrenia,delirium,anorexia nervosa,bulimia,autism,substance abuse(at least during 3 months ago ),mental retardation,adhd.4)Absence of psychiatric hospitalization history during 3 months ago.5)Absence of seizure history6)Absence of severe allergy history.7)Filling out informed consent.8)Absence of allergic history to sodium valproate. Exclusion criteria:1)Patients who evaluate at risk of suicide or homicide according to psychiatric diagnosis.2)Female patients are doubted for pregnancy, should test serum pregnancy test and will exclude from study if it is positive.3)Patients who take other drugs such as antimanic drugs that could not be able to stop them in two weeks before study or during it.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Severity of mania. Timepoint: Baseline,End of the third week,End of the six week. Method of measurement: Jung Mania Rating Scale(YMRS).;Cognitive scale. Timepoint: Baseline,End of the third week,End of the six week. Method of measurement: Mini Mental State Examination (MMSE).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAlireza Ebrahimi

Mashhad University of Medical Sciences

ebrahimia871@mums.ac.ir/alireza.ebrahimi37@yahoo.com+98 51 1883 1993

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Mar 8, 2026