Efficacy of Adding Folic Acid to Sodium Valproate on patients with Acute Mania

Phase 3

Conditions: Acute Mania.
Bipolar disorder, current episode manic without psychotic features

Registration Number: IRCT20180103038196N2

Lead Sponsor: Gorgan University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 60

Inclusion Criteria

Being at the age of 18 to 50 years
Diagnosis of type 1 bipolar disorder, being in mania episode based on diagnostic criteria DSM-5 (By a semi-structured interview by a psychiatrist and diagnosis based on minimum score 20 from the Young Mania Rating Scale)

Exclusion Criteria

Intolerance to increase the dose of the drug over a specified period of time.
Presence of anemia
Abnormal folic acid levels
Changing the diagnosis and rejection of the initial diagnosis during the course of treatment
History of ADHD
psychiatric diagnosis combined with medication and other diseases
history of admission to the psychiatric hospital during the past three months,
Positive pregnancy test in women
receive other medications, such as anti-mania treatments, two weeks prior to study or during the study
history of sodium valproate sensitivity

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement of acute mania based on the results of the used tests. Timepoint: The beginning of the study (before the intervention) and 3 and 6 weeks after the intervention. Method of measurement: Young Mania Rating Scale and Mini-Mental State Examination 1.

Secondary Outcome Measures