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Published Online: 1 February 2010

Olanzapine Long-Acting Injection: A 24-Week, Randomized, Double-Blind Trial of Maintenance Treatment in Patients With Schizophrenia

Abstract

Objective

The purpose of the present study was to evaluate the efficacy and tolerability of olanzapine long-acting injection for maintenance treatment of schizophrenia.

Method

Outpatients with schizophrenia who had maintained stability on an oral regimen of olanzapine (10, 15, or 20 mg/day) for 4 to 8 weeks were randomly assigned to 24 weeks of double-blind treatment with "low" (150 mg every 2 weeks; N=140), "medium" (405 mg every 4 weeks; N=318), or "high" (300 mg every 2 weeks; N=141) doses of olanzapine long-acting injection; a very low reference dose of olanzapine long-acting injection (45 mg every 4 weeks; N=144); or their stabilized dose of oral olanzapine (N=322). Rates of and time to psychotic exacerbation were estimated using Kaplan-Meier methodology.

Results

At 24 weeks, the majority of oral olanzapine-treated patients (93%), as well as most olanzapine long-acting injection-treated patients receiving high (95%), medium (90%), low (84%), and very low doses (69%), remained exacerbation free, with the therapeutic 4-week regimen (medium dose) and pooled 2-week regimen (low and high doses) demonstrating efficacy similar to that of oral olanzapine as well as to each other. The three standard long-acting doses were superior to the very low reference dose based on time to exacerbation. Incidence of weight gain ≥7% of baseline was 21% for oral olanza­pine compared with 21%, 15%, 16%, and 8% for the high, medium, low, and very low olanzapine long-acting treatment groups, respectively. No clinically significant differences were observed between the long-acting injection and oral olanzapine groups in general safety parameters. Few injection-site reactions occurred (3%). Two patients experienced sedation and delirium consistent with olanzapine overdose following possible accidental intravascular injection.

Conclusions

Olanzapine long-acting injection was efficacious in maintenance treatment of schizophrenia for up to 24 weeks, with a safety profile similar to oral olanzapine except for injection-related adverse events.

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Information & Authors

Information

Published In

Go to American Journal of Psychiatry
Go to American Journal of Psychiatry
American Journal of Psychiatry
Pages: 181 - 189
PubMed: 20008947

History

Received: 12 May 2009
Accepted: 27 August 2009
Published online: 1 February 2010
Published in print: February 2010

Authors

Details

Holland C. Detke, Ph.D.
Gopalan Sethuraman, Ph.D.
Richard F. Bergstrom, Ph.D.
David McDonnell, M.B., M.R.C.Psych.

Notes

Previously presented at the meeting of the Schizophrenia International Research Society, Venice, Italy, June 21–25, 2008; the Collegium Internationale Neuro-psychopharmacologicum, Munich, Germany, July 13–17, 2008; the World Congress of Psychiatry, Prague, Czech Republic, September 20–25, 2008; and the Institute on Psychiatric Services, Chicago, October 2–5, 2008. Received Aug. 2, 2007; revisions received Feb. 15 and Oct. 15, 2008 and May 15 and July 13, 2009; accepted July 24, 2009. From the Department of Psychiatry, Albert Einstein College of Medicine, Bronx, N.Y.; Lilly Research Laboratories, Indianapolis, Ind.; Department of Psychiatry and Psychotherapy, Centre for Psychosocial Medicine, University of Hamburg, Hamburg, Germany; Zucker Hillside Hospital, Glen Oaks, N.Y. Address correspondence and reprint requests to Dr. Kane, Department of Psychiatry, Zucker Hillside Hospital, North Shore-Long Island Jewish Health System, Albert Einstein College of Medicine, 75-59 263rd St., Glen Oaks, NY 11004; [email protected] (e-mail).

Competing Interests

Dr. Kane has served as a consultant to or on an advisory board of AstraZeneca, Bristol-Myers Squibb, Janssen, Eli Lilly, Pfizer, Wyeth, Cephalon, Proteus, Shire, Vanda, and PGxHealth; he has also served on the speakers bureau of AstraZeneca, Bristol-Myers Squibb, Janssen, and Eli Lilly. Dr. Naber has served as a consultant to or on an advisory board of AstraZeneca, Janssen-Cilag, Eli Lilly, Pfizer, and Wyeth; he has also served on the speakers bureau of AstraZeneca, Bristol-Myers Squibb, Janssen-Cilag, Eli Lilly, and Pfizer. Drs. Detke, Sethuraman, Lin, Bergstrom, and McDonnell are employed by Eli Lilly.

Funding Information

Supported by Eli Lilly and Company.ClinicalTrials.gov registry number, NCT00088491 (code: F1D-MC-HGKA) (www.clinicaltrials.gov).

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