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

Phase 3

• Conditions: Bipolar disorder.; Bipolar disorder

• Registration Number: IRCT20200307046712N1
• Lead Sponsor: Alborz University of Medical Science

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 18 May 2020

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 67

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

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).