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Olanzapine plus carbamazepine v. carbamazepine alone in treating manic episodes

Lilly Research Laboratories, Indianapolis, Indiana, and McLean Hospital, Harvard Medical School, Belmont, Massachusetts, USA

Charles L. Bowden, MD

Department of Psychiatry, University of Texas Health Science Center, San Antonio, Texas, USA

Anatoly B. Smulevich, MD, PhD

National Mental Health Research Center, Moscow, Russia

Richard Bergstrom, PhD, Tonya Quinlan and Olawale Osuntokun, MD

Lilly Research Laboratories, Indianapolis, Indiana, USA

Wei V. Wang, MS

Eli Lilly Canada, Danforth, Canada

Heather S. Oliff, PhD

Science Consulting Group, North Tustin, California, USA

Ferenc Martenyi, MD

Eli Lilly and Company, Area Medical Center, Vienna, Austria

Ludmila A. Kryzhanovskaya, MD, DrSc

Lilly Research Laboratories, Indianapolis, Indiana, USA

Waldemar Greil, MD

University of Munich, Germany

Correspondence: Dr M. Tohen, Lilly Research Laboratories, Indianapolis, IN 46285, USA. Email: m.tohen{at}lilly.com

Declaration of interest

Study sponsor: Eli Lilly & Company (employees: M.T., R.B., T.Q., O.O., W.W., F.M. and L.K.). Full declaration in Acknowledgements.

Background

Combinations of olanzapine and carbamazepine are often used in clinical practice in the management of mania.

Aims

To assess the efficacy and safety of olanzapine plus carbamazepine in mixed and manic bipolar episodes.

Method

Randomised, double-blind, 6-week trial of olanzapine (10–30 mg/day) plus carbamazepine (400–1200 mg/day; n=58) v. placebo plus carbamazepine (n=60) followed by open-label, 20-week olanzapine (10–30 mg/day) plus carbamazepine (400–1200 mg/day, n=86), with change in manic symptoms as main outcome measure. Safety and pharmacokinetics were also evaluated.

Results

There were no significant differences (baseline to endpoint) in efficacy measures between treatment groups, but at 6 weeks triglyceride levels were significantly higher (P=0.008) and potentially clinically significant weight gain (7%) occurred more frequently (24.6% v. 3.4%, P=0.002) in the combined olanzapine and carbamazepine group. Carbamazepine reduced olanzapine concentrations but olanzapine had no effect on carbamazepine concentrations.

Conclusions

The combination of olanzapine and carbamazepine did not have superior efficacy to carbamazepine alone. The increases in weight and triglycerides observed during combination treatment are a matter of concern.

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Highlights of this issue

Kimberlie Dean
BJP 2008 192: A6. [Full Text]