Effect of levetiracetam versus placebo on the clinical signs of in bipolar patients in the manic episode

Phase 2

Recruiting

• Conditions: Bipolar patients in the manic episode.; Bipolar disorder, current episode manic severe with psychotic features; F31.2

• Registration Number: IRCT20120215009014N293
• Lead Sponsor: Hamedan University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 7 October 2019

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

Age of 16 to 65 years,
Bipolar disorder in the manic phase,
Young score =20

Exclusion Criteria

Bipolar disorder in the depressive phase

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical signs. Timepoint: Before the intervention and 14 and 28 days after that. Method of measurement: Using the Young Mania Rating Scale (YMRS).;Sleep quality. Timepoint: Before the intervention and 14 and 28 days after that. Method of measurement: Using the Pittsburgh Standard Questionnaire.;Cognitive function. Timepoint: Before the intervention and 14 and 28 days after that. Method of measurement: Using the Montreal Cognitive Assessment (MoCA).

Secondary Outcome Measures

Name	Time	Method
Gastric complications. Timepoint: 28 days after the intervention. Method of measurement: By history taking.