An 8-Week, Double-Blind, Randomized, Placebo-Controlled Study of Olanzapine Long-Acting Injection in Acutely Ill Patients With Schizophrenia
J Clin Psychiatry 2008;69(5):790-799
© Copyright 2016 Physicians Postgraduate Press, Inc.
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Objective: To examine the efficacy and tolerability of a new
injectable formulation of olanzapine, olanzapine long-acting injection (LAI),
relative to placebo for treatment of acutely ill patients with schizophrenia.
Method: Patients with DSM-IV or DSM-IV-TR schizophrenia in
this 8-week, double-blind study were randomly assigned to receive 210 mg/2
weeks, 300 mg/2 weeks, or 405 mg/4 weeks of olanzapine LAI or placebo/2 weeks.
No oral antipsychotic supplementation was permitted. The primary efficacy
measure was mean baseline-to-end point change in Positive and Negative Syndrome
Scale (PANSS) total score. The study was conducted from June 2004 to April
Results: Mean baseline-to-end point decreases in PANSS total
scores were significantly greater for all olanzapine LAI regimens relative to
placebo (all p values < .001). The 300 mg/2 weeks and 405 mg/4 weeks olanzapine
LAI groups separated from placebo on the PANSS total at 3 days after starting
treatment, and all olanzapine LAI groups separated from placebo by 7 days.
Rates of clinical improvement (end point Clinical Global
Impressions-Improvement scale score <= 3) were significantly higher for all
olanzapine LAI groups relative to placebo (p < .001). Incidences of sedation
and increased appetite were significantly higher for 300 mg/2 weeks olanzapine
LAI relative to placebo (p < .05). Mean weight gain (3.2-4.8 vs. 0.3 kg, p <
.001) and incidence of weight gain >= 7% of baseline (23.6-35.4% vs. 12.4%, p
<= .046) were significantly greater for olanzapine LAI relative to placebo.
Significant differences between all olanzapine LAI groups and placebo were
observed regarding mean baseline-to-end point changes in fasting total
cholesterol (5.5-10.4 vs. -7.0 mg/dL; p <= .015) and between the 210 mg/2 weeks
and 405 mg/4 weeks groups (26.3-30.3 vs. -9.4 mg/dL; p <= .016), but not the
300 mg/2 weeks group (17.6 mg/dL; p = .055), and placebo for fasting
Conclusions: In this 8-week study, olanzapine LAI administered
at 2- or 4-week injection intervals was significantly more efficacious than
placebo for the treatment of acutely ill patients with schizophrenia despite no
use of supplemental oral antipsychotics. Consistent with changes previously
observed with oral olanzapine, clinically significant weight gain and changes
in some lipid parameters were observed in patients treated with olanzapine LAI.
Trial Registration:clinicaltrials.gov Identifier: NCT00088478