Safety and efficacy of olanzapine monotherapy in treatment-resistant bipolar mania: a 12-week open-label study

✍ Scribed by Jun Chen; David J. Muzina; David E. Kemp; Carla Conroy; Philip Chan; Mary Beth Serrano; Stephen J. Ganocy; Yiru Fang; Joseph R. Calabrese; Keming Gao

• Publisher: John Wiley and Sons
• Year: 2011
• Tongue: English
• Weight: 190 KB
• Volume: 26
• Category: Article
• ISSN: 0885-6222
• DOI: 10.1002/hup.1249

✦ Synopsis

Objective

To examine the safety and efficacy of olanzapine monotherapy in treatment‐resistant bipolar mania.

Method

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.

Results

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.

Conclusions

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.