An interventional study to see outcome by comparing efficiency and safety of two drugs i.e. of levetiracetam versus oxcarbazepine in management of bipolar disorder.
Phase 3
- Conditions
- Health Condition 1: F316- Bipolar disorder, current episodemixed
- Registration Number
- CTRI/2024/04/065780
- Lead Sponsor
- ttar Pradesh University of Medical sciences Department of Pharmacology and Psychiatry
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Meet ICD -10 criteria.
No previous history of psychiatry illness
Exclusion Criteria
Any Pregnant or nursing mother
Unstable or uncontrolled cardiovascular disease Evidence of recent ischemic event
Hypertension or metabolic disorder
Any history of seizure disorder or ischemic stroke
Any malignancy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method reduction in mood episodes as well as the time recurrence of mood episodes <br/ ><br>the study may find the one drug to be superior or equivalent to the other in terms of efficacyTimepoint: baseline <br/ ><br>3rd week <br/ ><br>6th week <br/ ><br>9th week <br/ ><br>12th week <br/ ><br>
- Secondary Outcome Measures
Name Time Method Secondary outcome measures could include the improvement in quality of life such as functioning or cognitive performance It is expected that both drugs will improve these outcomeTimepoint: baseline <br/ ><br>3rd week <br/ ><br>6th week <br/ ><br>9th week <br/ ><br>12th week