Comparative Efficacy and Tolerability of Oxcarbazepine, Carbamazepine, and Lithium in the Treatment of Acute Mania

Background: Carbamazepine is an established mood stabilizer for the treatment of acute mania; however, its clinical use is often limited by adverse effects. Oxcarbazepine, a structural analogue of carbamazepine, has been suggested as a potentially better-tolerated alternative, though evidence regarding its efficacy in mania remains limited and inconsistent. Objectives: To compare the efficacy and tolerability of oxcarbazepine with carbamazepine in patients with acute manic episodes, using lithium as an active control. Methods: This randomized, open-label, lithium-controlled trial was conducted at a tertiary care government hospital. Ninety patients diagnosed with a manic episode as per DSM-IV-TR criteria and having a Young Mania Rating Scale (YMRS) score ≥20 were randomized in a 1:1:1 ratio to receive oxcarbazepine, carbamazepine, or lithium and were followed for six weeks. The primary outcome was adequate response, defined as a ≥50% reduction in YMRS score from baseline. Safety and tolerability were assessed using the Systematic Assessment for Treatment-Emergent Effects (SAFTEE) checklist along with clinical and laboratory monitoring. Statistical analysis was performed using SPSS version 16, with p