Trial reportBMC psychiatry2013
A randomized, double-blind, placebo-controlled study of rapid-acting intramuscular olanzapine in Japanese patients for schizophrenia with acute agitation.
Trial report in BMC psychiatry, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT00970281 (A Double-Blind Confirmatory Study Comparing Rapid-Acting Intramuscular Olanzapine and Rapid-Acting Intramuscular Placebo in Patients With an Exacerbation of Schizophrenia With Acute Psychotic Agitation), which is not on this map. Cited by 11 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Double-Blind Confirmatory Study Comparing Rapid-Acting Intramuscular Olanzapine and Rapid-Acting Intramuscular Placebo in Patients With an Exacerbation of Schizophrenia With Acute Psychotic Agitation
Who cites it
11 citing papers in PubMed, 1 synthesis or guideline pooled it, 26 citations in OpenAlex.
- Brazilian guidelines for the management of psychomotor agitation. Part 2. Pharmacological approach.Revista brasileira de psiquiatria (Sao Paulo, Brazil : 1999)Pooled it
- Intramuscular Generic Injection (QLG2072) versus Haloperidol in Chinese Patients with Acute Agitation: A Phase 3 Multicenter, Randomized, Double-Blind, Active-Controlled Trial.Drug design, development and therapy · 2026Trial
- Guideline for pharmacological treatment of schizophrenia 2022.Neuropsychopharmacology reports · 2025Article
- Japanese Society of Neuropsychopharmacology: "Guideline for Pharmacological Therapy of Schizophrenia".Neuropsychopharmacology reports · 2021Article
- Use of olanzapine to treat agitation in traumatic brain injury: study protocol for a randomised controlled trial.Trials · 2020Article
- [Comparison of sublingual and intravenous administration of lorazepam in psychiatric emergencies in emergency medical services].Der Anaesthesist · 2019Article
- Effects of atypical antipsychotic drugs on QT interval in patients with mental disorders.Annals of translational medicine · 2018Article
- Effectiveness and safety of oral olanzapine treatment transitioned from rapid-acting intramuscular olanzapine for agitation associated with schizophrenia.Neuropsychiatric disease and treatment · 2018Article
- Safety and effectiveness of rapid-acting intra-muscular olanzapine for agitation associated with schizophrenia - Japan postmarketing surveillance study.Neuropsychiatric disease and treatment · 2018Article
- Efficacy of Atypical Antipsychotics in the Management of Acute Agitation and Aggression in Hospitalized Patients with Schizophrenia or Bipolar Disorder: Results from a Systematic Review.Shanghai archives of psychiatry · 2016Review
- Erratum: A randomized, double-blind, placebo-controlled study of rapid-acting intramuscular olanzapine in Japanese patients for schizophrenia with acute agitation.BMC psychiatry · 2014Article
Corrections and comments
- Erratum issued
- Erratum issued
Authors and funding
7 authors at 4 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundOlanzapine 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.
methodsWe 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.
resultsOf 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.
conclusionThe 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 registrationNCT00970281.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.