A randomized, open label trial to compare efficacy and safety of levetiracetam versus oxcarbazepine in management of bipolar disorder.

The purpose of the present study is to evaluate the efficacy and safety of the Levetiracetam and Oxcarbazepine for the management of newly diagnosed bipolar disorder patients in Indian rural tertiary care center and further to determine which is more promising among both drugs. Newly diagnosed patient for bipolar disorder will be randomized for the test drugs i.e., Levetiracetam & Oxcarbazepine. Patient will be randomly assigned in 1:1 ratio to each group and each group will consist of minimum 50 patients. Group 1 will receive Levetiracetam and group 2 will receive Oxcarbazepine on 1st day and will be followed up every 3 weeks until 12 weeks. The primary endpoint is response defined for burden of illness via Patient Global Impression of Change Scale i.e., mild change: 1-3, moderate change: 3-5 & severe change: 5-7. The study will also include as Hamilton Depression Rating Scale (HDRS) in depressive phase with a score assessment: 0-7 = normal, 8-13= mild depression, 14-18= moderate depression, & more than 23 = very severe depression. And lastly using Young Mania Rating Scale (YMRS). The secondary endpoint will be in response defined using statistical analysis via ANOVA, Student’s t- Test and CHI SQUARE for qualitative and quantitative assessment.