Investigating of vitamin B6 in Bipolar Mood disorder

Investigating the effect of vitamin B6 as an add-on treatment to lithium compared to placebo on the symptoms of acute mania and the recurrence of mood episodes and suicidal thoughts in patients with bipolar disorder type 1; A double-blind clinical trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20190316043072N4

Enrollment

Registered

2024-01-05

Start date

2024-01-21

Completion date

Unknown

Last updated

2024-01-22

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

Conditions

Bipolar disorder. Bipolar disorder

Interventions

Intervention 1: Intervention group: lithium carbonate tablets (300 mg), three times a day along with vitamin B6 (40 mg) a day for 24 weeks. Intervention 2: Control group: lithium carbonate tablets (30

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

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

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)

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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

Measure	Time frame
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.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Atefeh Zandifar

Karaj University of Medical Sciences

zandifaratefe@gmail.com0098 32563328026

Outcome results

None listed

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