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

Authors

  • Jun Chen,

    1. Division of Mood Disorders, Shanghai Mental Health Center, Shanghai Jiao Tong University, School of Medicine, Shanghai, China
    2. Department of Psychiatry, Mood Disorders Program, Case Western Reserve University School of Medicine, University Hospitals Case Medical Center, Cleveland, Ohio, USA
    Current affiliation:
    1. Department of Psychiatry, Mood Disorders Program, Case Western Reserve University School of Medicine, University Hospitals Case Medical Center, Cleveland, Ohio, USA
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  • David J. Muzina,

    1. Department of Psychiatry, Mood Disorders Program, Cleveland Clinic, Cleveland, Ohio, USA
    2. Medco Health Solutions, Inc, Franklin Lakes, New Jersey, USA
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  • David E. Kemp,

    1. Department of Psychiatry, Mood Disorders Program, Case Western Reserve University School of Medicine, University Hospitals Case Medical Center, Cleveland, Ohio, USA
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  • Carla Conroy,

    1. Department of Psychiatry, Mood Disorders Program, Case Western Reserve University School of Medicine, University Hospitals Case Medical Center, Cleveland, Ohio, USA
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  • Philip Chan,

    1. Department of Psychiatry, Mood Disorders Program, Case Western Reserve University School of Medicine, University Hospitals Case Medical Center, Cleveland, Ohio, USA
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  • Mary Beth Serrano,

    1. Department of Psychiatry, Mood Disorders Program, Case Western Reserve University School of Medicine, University Hospitals Case Medical Center, Cleveland, Ohio, USA
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  • Stephen J. Ganocy,

    1. Department of Psychiatry, Mood Disorders Program, Case Western Reserve University School of Medicine, University Hospitals Case Medical Center, Cleveland, Ohio, USA
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  • Yiru Fang,

    Corresponding author
    • Division of Mood Disorders, Shanghai Mental Health Center, Shanghai Jiao Tong University, School of Medicine, Shanghai, China
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  • Joseph R. Calabrese,

    1. Department of Psychiatry, Mood Disorders Program, Case Western Reserve University School of Medicine, University Hospitals Case Medical Center, Cleveland, Ohio, USA
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  • Keming Gao

    Corresponding author
    • Department of Psychiatry, Mood Disorders Program, Case Western Reserve University School of Medicine, University Hospitals Case Medical Center, Cleveland, Ohio, USA
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  • 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.

K. Gao, MD, PhD, Department of Psychiatry, Mood Disorders Program, Case Western Reserve University School of Medicine, University Hospitals Case Medical Center, 10524 Euclid Ave, 12th Floor, Cleveland, Ohio, USA 44106. Tel: 1-216-844-2865; Fax: 1-216-844-2875 E-mail: keming.gao@uhhospitals.org

Y. Fang, MD, PhD, Division of Mood Disorders, Shanghai Mental Health Center, Shanghai Jiao Tong University, School of Medicine, 600 S. Wan Ping Rd, Shanghai 200030, China. E-mail: yirufang@yahoo.com.cn

Abstract

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.

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