The effect of vitamin B6 in bipolar patients
- Conditions
- BIPOLAR DISORDER.Bipolar mood disorder
- Registration Number
- IRCT20200317046801N1
- Lead Sponsor
- Tehran University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 50
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
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).
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.