evetiracetam as adjuvant therapy in acute mania
Phase 3
- Conditions
- Bipolar Disorder.Bipolar disorder
- Registration Number
- IRCT20090117001556N117
- Lead Sponsor
- Tehran University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
Meeting the DSM-IV criteria for Bipolar Disorder-manic episode
Age between 18 and 60 years old
A score of at least 20 points on the Young Mania Rating Scale
Exclusion Criteria
Hyper- or hypothyroidism
Substance dependence(except for Nicotine and caffeine)
IQ lower than 70
Lactating or pregnant women
Severe hepatic disease
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Severity of mania. Timepoint: Baseline and weerks: 2, 4, 6. Method of measurement: by Young Mania Rating Scale.
- Secondary Outcome Measures
Name Time Method