Comparison of Two Forms of Oxcarbazepine for the Treatment of Bipolar Depression

Summary

Consenting subjects with Bipolar depression will remain under the care of their local (psychiatric) care provider and be randomized to a six week course of one of two forms of oxcarbazepine (extended release or immediate release. Study outcomes will be assessed based on outcome measures administered to the subject at home by a computer simulated rater. Local care providers will receive "pre-assessment" reports ahead of each clinical visit, rate the Clinical Global Impression for Severity, and evaluate adverse effects. The primary outcome variable is "treatment effectiveness" operationally defined as the response rate X the completion rate.

Timeline

Start

2018-06-13

Primary completion

2019-09-30

Completion

2019-09-30

Publications

• Background Benedetti A, Lattanzi L, Pini S, Musetti L, Dell'Osso L, Cassano GB. Oxcarbazepine as add-on treatment in patients with bipolar manic, mixed or depressive episode. J Affect Disord. 2004 Apr;79(1-3):273-7. doi: 10.1016/S0165-0327(02)00407-X.
• Background Ghaemi SN, Berv DA, Klugman J, Rosenquist KJ, Hsu DJ. Oxcarbazepine treatment of bipolar disorder. J Clin Psychiatry. 2003 Aug;64(8):943-5. doi: 10.4088/jcp.v64n0813.
• Background Sachs GS, Nierenberg AA, Calabrese JR, Marangell LB, Wisniewski SR, Gyulai L, Friedman ES, Bowden CL, Fossey MD, Ostacher MJ, Ketter TA, Patel J, Hauser P, Rapport D, Martinez JM, Allen MH, Miklowitz DJ, Otto MW, Dennehy EB, Thase ME. Effectiveness of adjunctive antidepressant treatment for bipolar depression. N Engl J Med. 2007 Apr 26;356(17):1711-22. doi: 10.1056/NEJMoa064135. Epub 2007 Mar 28.
• Background Morris DW, Trivedi MH. Measurement-based care for unipolar depression. Curr Psychiatry Rep. 2011 Dec;13(6):446-58. doi: 10.1007/s11920-011-0237-8.

Drugs

Indications