Investigating of vitamin B6 in Bipolar Mood disorder

Phase 3

Recruiting

Conditions: Bipolar disorder.
Bipolar disorder

Registration Number: IRCT20190316043072N4

Lead Sponsor: Karaj University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 80

Inclusion Criteria

Having DSM-V diagnostic criteria for bipolar patients (through a semi-structured interview by a psychiatrist and confirming the diagnosis with a score of at least 20 on the Young Mania scale).
Being at the age of 18 to 65 years old

Exclusion Criteria

Suffering from neurological disease, cardiovascular and liver disease and chronic kidney disease
IQ less than 70
Drug abuse (except nicotine and caffeine)
History of drug sensitivity to lithium carbonate or vitamin B6
Pregnancy and breastfeeding
chronic kidney disease (CKD)

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mood symptoms. Timepoint: Before and after the intervention (at intervals of weeks 0-4-8-12-18-24-32). Method of measurement: Young Mania standard questionnaire and brief clinical examination test.;Improve sleep quality. Timepoint: Before and after the intervention (at intervals of weeks 0-4-8-12-18-24-32). Method of measurement: Petersburg Sleep Quality Questionnaire.;Cognitive symptoms. Timepoint: Before and after the intervention (at intervals of weeks 0-4-8-12-18-24-32). Method of measurement: Mini-Mental State Examination (MMSE).;Suicidal thoughts. Timepoint: Before and after the intervention (at intervals of weeks 0-4-8-12-18-24-32). Method of measurement: Beck suicide questionnaire.

Secondary Outcome Measures

Name	Time	Method
Symptoms of depression. Timepoint: Before and after the intervention (at intervals of weeks 0-4-8-12-18-24-32). Method of measurement: Beck depression questionnaire.;Anxiety symptoms. Timepoint: Before and after the intervention (at intervals of weeks 0-4-8-12-18-24-32). Method of measurement: Beck's anxiety questionnaire.