Dr. Jun Chen was a research scholar funded by the World Psychiatric Association from 2/2010 to 2/2011 and was trained in the Department of Psychiatry, Mood Disorders Program, Case Western Reserve University School of Medicine, University Hospitals Case Medical Center, Cleveland, Ohio.
Safety and efficacy of olanzapine monotherapy in treatment-resistant bipolar mania: a 12-week open-label study
Version of Record online: 15 NOV 2011
Copyright © 2011 John Wiley & Sons, Ltd.
Human Psychopharmacology: Clinical and Experimental
Volume 26, Issue 8, pages 588–595, December 2011
How to Cite
Chen, J., Muzina, D. J., Kemp, D. E., Conroy, C., Chan, P., Serrano, M. B., Ganocy, S. J., Fang, Y., Calabrese, J. R. and Gao, K. (2011), Safety and efficacy of olanzapine monotherapy in treatment-resistant bipolar mania: a 12-week open-label study. Hum. Psychopharmacol. Clin. Exp., 26: 588–595. doi: 10.1002/hup.1249
- Issue online: 13 DEC 2011
- Version of Record online: 15 NOV 2011
- Manuscript Accepted: 19 OCT 2011
- Manuscript Received: 8 FEB 2011
- National Institutes of Health
- Department of Defense
- Health Resources Services Administration
- National Institute of Mental Health
- bipolar disorder;
- treatment-resistant mania;
- second generation antipsychotic;
- treatment outcome;
To examine the safety and efficacy of olanzapine monotherapy in treatment-resistant bipolar mania.
Subjects (n = 18) who were acutely manic, did not respond to lithium, anticonvulsants, and neuroleptics, and/or had intolerable side effects to them in previous manic episodes were openly treated with olanzapine monotherapy (5–40 mg/d) for 12 weeks. The primary and secondary outcomes included the change from baseline to endpoint in Young Mania Rating Scale (YMRS) total score, Clinical Global Impression for Bipolar Disorder-Severity Scale (CGI-S), 17-item Hamilton Depression Rating Scale (HAM-D) and Positive and Negative Syndrome Scale (PANSS), and response and remission rate.
The mean change in YMRS total score from baseline to endpoint was −23.3 ± 8.4 (p < 0.001). Fifteen (88.5%) patients achieved response (≥50% reduction in YMRS total score) and 14 (77.8%) achieved remission (YMRS total score ≤9 at endpoint). Mean changes from baseline to endpoint in CGI-S for mania and PANSS total score were significant, but not the changes in HAM-D total score or CGI-S for depression. The most common adverse events were sedation, self-reported weight gain, ≥7% increase in body weight, dizziness, and akathisia.
These preliminary results suggest that olanzapine monotherapy is effective and relatively safe in patients with treatment-resistant bipolar mania. Randomized, double-blind, placebo-controlled study is warranted. Copyright © 2011 John Wiley & Sons, Ltd.