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Open Access Research article

A randomized, double-blind, placebo-controlled study of rapid-acting intramuscular olanzapine in Japanese patients for schizophrenia with acute agitation

Hideaki Katagiri1*, Shinji Fujikoshi1, Takuya Suzuki2, Kiyoshi Fujita3, Naoya Sugiyama4, Michihiro Takahashi16 and Juan-Carlos Gomez5

Author affiliations

1 Lilly Research Laboratories Japan, Eli Lilly Japan K.K, Kobe, Japan

2 Ayase Hospital, 6-3-1 Ayase, Adachi-ku, Tokyo, 120-0005, Japan

3 Seishinkai Okehazama Hospital Fujita Kokoro Care Center, 3-879 Sakaecho Minamiyakata, Toyoake-shi, Aichi, 470-1168, Japan

4 Numazu Chuo Hospital, 24-1 Nakasecho, Numazu-shi, Shizuoka, 410-0811, Japan

5 Lilly Research Laboratories, Lilly Corporate Center, Indianapolis, IN, 46285, USA

6 Takahashi Psychiatric Clinic, Ashiya, Hyogo, Japan

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Citation and License

BMC Psychiatry 2013, 13:20  doi:10.1186/1471-244X-13-20

Published: 11 January 2013

Abstract

Background

Olanzapine rapid-acting intramuscular (IM) injection is an atypical antipsychotic drug already used overseas and recently approved in Japan. The objective of this study was to confirm the efficacy of rapid-acting IM olanzapine 10 mg was greater than IM placebo in patients with exacerbation of schizophrenia with acute psychotic agitation by comparing changes from baseline to 2 hours after the first IM injection, as measured by the Positive and Negative Syndrome Scale-Excited Component (PANSS-EC) total score.

Methods

We conducted a placebo-controlled, randomized, double-blind, parallel-group study in Japanese patients diagnosed with schizophrenia according to the diagnostic criteria specified in the DSM-IV-TR. Patients were randomized to 2 treatment groups: IM olanzapine (10 mg) or IM placebo. The primary efficacy outcome was the change in PANSS-EC from baseline to 2 hours after the first IM injection. Treatment groups were compared with an analysis of variance model which included treatment and site as factors. During the 24-hour treatment period, safety was assessed by clinical examination and laboratory investigations, electrocardiograms, extrapyramidal symptoms scales, and recording spontaneously reported adverse events.

Results

Of the 91 randomized patients, 90 patients (45 IM olanzapine-group; 45 IM placebo-group) were in the full analysis set. The mean change of PANSS-EC total score from baseline to 2 hours after the first IM injection (mean±standard deviation) was −9.2±4.5 for the IM olanzapine group and −2.8±5.6 for the IM placebo group. The difference between treatment groups was statistically significant (p<.001). There were no deaths, serious adverse events, treatment-emergent adverse events (TEAEs) leading to discontinuation, severe TEAEs, or instances of oversedation in this study. There were no statistically significant differences between treatment groups in the proportion of patients with potentially clinically significant changes in laboratory tests, vital signs (blood pressure and pulse rate), electrocardiograms, and treatment-emergent extrapyramidal symptoms.

Conclusion

The efficacy of IM olanzapine 10 mg in patients with exacerbation of schizophrenia with acute psychotic agitation was greater than IM placebo in the primary efficacy measure, PANSS-EC. Intramuscular olanzapine 10 mg was shown to be generally safe and tolerable, and could be a new option for treatment of schizophrenia in Japan.

Trial Registration

NCT00970281

Keywords:
Rapid-acting intramuscular olanzapine; Schizophrenia; Acute psychotic agitation; Japanese