Skip to content

The effect of vitamin B6 in bipolar patients

Evaluation of the effect of vitamin B6 as adjunctive therapy in ameliorating symptoms of acute mania in patients with bipolar disorder Type 1 hospitalized in Roozbeh Hospital; a double-blind placebo-controlled clinical trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20200317046801N1
Enrollment
50
Registered
2020-03-27
Start date
2019-11-01
Completion date
Unknown
Last updated
2020-04-21

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

Conditions

BIPOLAR DISORDER. Bipolar mood disorder

Interventions

Intervention 1: Fifty Patients with type 1 bipolar disorder in the mania phase are randomly divided into two groups. 25patients in the intervention group receive standard lithium carbonate and vitamin

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Subjects aged 18 to 65 years old Diagnosis of type 1 bipolar disorder in early-onset mania based on DSM-V diagnostic criteria (by semi-structured interview by a psychiatrist and confirmation of diagnosis with a score of at least 20 on the Young Mania Scale). Consent of the possibility of being present on the patient's legal guardian

Exclusion criteria

Exclusion criteria: Absence of psychosis in patients A history of drug sensitivity to lithium carbonate or vitamin B6 Absence of diagnoses of schizophrenia, delirium, anorexia neurosis, bulimia neurosis, autism, substance abuse (at least 3 months ago), retardation Bipolar type 2 seizures (Existence of suicide due to lack of suicide risk factor for use of evaluated drugs as well as weekly weekly medications and low weekly prescription drugs are not included in the plan).

Design outcomes

Primary

MeasureTime frame
Mania Symptoms by Young Mania Questionnaire. Timepoint: Baseline and weeks 3, 4, and 8 after vitamin B6 start. Method of measurement: Yang Mania questionnaire.

Secondary

MeasureTime frame
Sleep quality. Timepoint: Baseline and weeks 3, 4, and 8 after vitamin B6 start. Method of measurement: Petersburg questionnaire.;Nutrition and appetite status. Timepoint: Baseline and weeks 3, 4, and 8 after vitamin B6 start. Method of measurement: Appetite Rating Scale.;Mini mental status. Timepoint: Baseline and weeks 3, 4, and 8 after vitamin B6 start. Method of measurement: Mini mental status examination.;Brain Mapping. Timepoint: Baseline and week , 8 after vitamin B6 start. Method of measurement: QEEG | Quantitative Electroencephalogram Test.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactRahim Badrfam

Tehran University of Medical Sciences

rbadrfam@gmail.com+98 21 5541 9151

Outcome results

None listed

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