Evaluation of the effect of vitamin B1 and B6 in manic patients

Evaluation of the effect of vitamin B1 and B6 as an adjunct therapy to improve the symptoms of mania phase of bipolar disorder type I; in a double-blind and placebo-controlled clinical trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20200307046712N1

Enrollment

Registered

2020-04-06

Start date

2020-03-14

Completion date

Unknown

Last updated

2020-05-18

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: First intervention group: This group will take 1.5 mg/kg vitamin B1 plus 900 mg lithium bicarbonate. Intervention 2: Second international group: This group will take 0.6 mg/kg vitamin

Eligibility

Sex/Gender

All

Age

18 Years to 50 Years

Inclusion criteria

Inclusion criteria: Having diagnostic criteria of DSM-V for mania phase of patients with bipolar disorder Having at least 14 scores in Young-Mania questionnaire Aged between 18 to 50 Getting conscious letter of satisfaction from patient tutor

Exclusion criteria

Exclusion criteria: Having any neurological, organic, cardiovascular and hepatic disorder according to patients? evidences or history Existence of any other diagnosis in axis I disorders according to DSM-V IQ less than 70 according to examiner clinical judge Drug abuse (except nicotine and caffeine ) Alcohol abuse coincidentally Women in reproductive ages without using a safe contraception Patient with CHF (congestive heart failure) or liver disease Absence of satisfaction for starting or continuing participating

Design outcomes

Primary

Measure	Time frame
Mood symptoms . Timepoint: In this study, mood symptoms will be assessed in the beginning of and at the end of the 8th week of the clinical trial. Method of measurement: Mood symptoms will be assessed according to the score of the Young-Mania questionnaire .	—

Secondary

Measure	Time frame
Cognition state. Timepoint: In this study, the cognition state of the patients will be assessed in the beginning and at the end of the 8th week of the clinical trial. Method of measurement: The cognition state of the patients will be assessed according to the score of the Minimal Mental State Exam (MMSE).;The sleep state. Timepoint: In this study, the sleep state of the patients will be assessed in the beginning and at the end of the 8th week of the clinical trial. Method of measurement: The sleep state pf the patients will be assessed according to the score of Pittsburgh Sleep Quality Questionnaire Index(PSQI).	—

Measure

Time frame

Cognition state. Timepoint: In this study, the cognition state of the patients will be assessed in the beginning and at the end of the 8th week of the clinical trial. Method of measurement: The cognition state of the patients will be assessed according to the score of the Minimal Mental State Exam (MMSE).;The sleep state. Timepoint: In this study, the sleep state of the patients will be assessed in the beginning and at the end of the 8th week of the clinical trial. Method of measurement: The sleep state pf the patients will be assessed according to the score of Pittsburgh Sleep Quality Questionnaire Index(PSQI).

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactShaghayegh Mousavi

Alborz university of medical sciences

mvishaghayegh@gmail.com+98 26 3340 1629

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 10, 2026