Cited by 120Schizophrenia research and treatmentTreatment of Major DepressionNeurotransmitter Receptor Influence on Behavior

An 8-week, double-blind, randomized, placebo-controlled study of olanzapine long-acting injection in acutely ill patients with schizophrenia

Lauriello, John, Lambert, Tim, Andersen, Scott, Lin, Daniel, Taylor, Cindy C., McDonnell, David·2008·The Journal of Clinical Psychiatry

Abstract

Article AbstractObjective: 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 2005. 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 = 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 triglycerides. 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

Integrity signals

Registry

Crossref · 10.4088/jcp.v69n0512

Cites

Statistics

Recomputing p-values needs the paper’s full text.

Claims the paper makes

This paper’s full text isn’t openly available, so its claims and self-check weren’t run. The registry and citation checks still apply.

Claims other papers make about this one

Each is checked against this paper’s own text: does it say what the citing paper says it does?

Cited by

Sorted by citations

Authors
Lauriello, J., Lambert, T., Andersen, S., Lin, D., Taylor, C. C., & McDonnell, D.
Affiliations
University of New Mexico (US)
Venue
The Journal of Clinical Psychiatry
Published
2008-05-15
Volume
69
Issue
5
Pages
790-799
ISSN
0160-6689 (ISSN-L)
OpenAlex
W2076607047
Cited by
120
References
0
Citations by year
2026: 1 · 2025: 4 · 2024: 2 · 2023: 5 · 2022: 3 · 2021: 3 · 2019: 5 · 2018: 3 · 2017: 3 · 2016: 10 · 2015: 7 · 2014: 14 · 2013: 18 · 2012: 9
FWCI
7.73
Type
journal article
Language
en
Open access
closed
Locations
  • The Journal of Clinical Psychiatry (publishedVersion)
  • PubMed (publishedVersion)
Topics
  • Health Sciences › Medicine › Psychiatry and Mental health › Schizophrenia research and treatment
  • Health Sciences › Medicine › Pharmacology › Treatment of Major Depression
  • Life Sciences › Neuroscience › Cellular and Molecular Neuroscience › Neurotransmitter Receptor Influence on Behavior
Keywords
schizophrenia, acute schizophrenia, antipsychotic efficacy, tolerability, PANSS, sedation, weight gain, hypertriglyceridemia, adverse effects, injectable antipsychotics, dose comparison, relapse prevention
MeSH terms
Olanzapine, Acute Disease, Adolescent, Adult, Aged, Benzodiazepines, Delayed-Action Preparations, Double-Blind Method, Female, Humans, Injections, Intramuscular, Male, Middle Aged, Schizophrenia, Diagnostic and Statistical Manual of Mental Disorders

About these checks

Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.

Statistics and arithmetic are recomputed, not judged.

Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.

What counts as a claim ›How we measure confidence ›How we check this ›

Are you an author, or do you see a problem with this page? Request a review