Efficacy and safety of asenapine in a placebo- and haloperidol-controlled trial in patients with acute exacerbation of schizophrenia

Kane, John M.; Cohen, Michael; Zhao, Jun; Alphs, Larry; Panagides, John

doi:10.1097/jcp.0b013e3181d35d6b

Cited by 126Schizophrenia research and treatmentBipolar Disorder and TreatmentTreatment of Major Depression

Efficacy and safety of asenapine in a placebo- and haloperidol-controlled trial in patients with acute exacerbation of schizophrenia

Kane, John M., Cohen, Michael, Zhao, Jun, Alphs, Larry, Panagides, John·2010·Journal of Clinical Psychopharmacology

DOI 10.1097/jcp.0b013e3181d35d6b

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Abstract

Asenapine is approved by the Food and Drugs Administration in adults for acute treatment of schizophrenia or of manic or mixed episodes associated with bipolar I disorder with or without psychotic features. In a double-blind 6-week trial, 458 patients with acute schizophrenia were randomly assigned to fixed-dose treatment with asenapine at 5 mg twice daily (BID), asenapine at 10 mg BID, placebo, or haloperidol at 4 mg BID (to verify assay sensitivity). With last observations carried forward (LOCF), mean Positive and Negative Syndrome Scale total score reductions from baseline to endpoint were significantly greater with asenapine at 5 mg BID (-16.2) and haloperidol (-15.4) than placebo (-10.7; both P < 0.05); using mixed model for repeated measures (MMRM), changes at day 42 were significantly greater with asenapine at 5 and 10 mg BID (-21.3 and -19.4, respectively) and haloperidol (-20.0) than placebo (-14.6; all P < 0.05). On the Positive and Negative Syndrome Scale positive subscale, all treatments were superior to placebo with LOCF and MMRM; asenapine at 5 mg BID was superior to placebo on the negative subscale with MMRM and on the general psychopathology subscale with LOCF and MMRM. Treatment-related adverse events (AEs) occurred in 44% and 52%, 57%, and 41% of the asenapine at 5 and 10 mg BID, haloperidol, and placebo groups, respectively. Extrapyramidal symptoms reported as AEs occurred in 15% and 18%, 34%, and 10% of the asenapine at 5 and 10 mg BID, haloperidol, and placebo groups, respectively. Across all groups, no more than 5% of patients had clinically significant weight change. Post hoc analyses indicated that efficacy was similar with asenapine and haloperidol; greater contrasts were seen in AEs, especially extrapyramidal symptoms.

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Only 2 of 6 completed monotherapy trials are currently published but without results of neurocognitive testing.
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Authors: Kane, J. M., Cohen, M., Zhao, J., Alphs, L., & Panagides, J.
Affiliations: Zucker Hillside Hospital (US)
Merck & Co., Inc., Rahway, NJ, USA (United States) (US)
Pfizer (United States) (US)
Corresponding author: Kane, John M.
ORCID: Kane, John M.
Zhao, Jun
Alphs, Larry
Panagides, John
Venue: Journal of Clinical Psychopharmacology
Publisher: Ovid Technologies (Wolters Kluwer Health)
Published: 2010-04
Volume: 30
Issue: 2
Pages: 106-115
ISSN: 0271-0749 (ISSN-L)
DOI: 10.1097/jcp.0b013e3181d35d6b
OpenAlex: W2050370233
Cited by: 126
References: 46
Citations by year: 2025: 2 · 2024: 7 · 2023: 1 · 2022: 6 · 2021: 7 · 2020: 6 · 2019: 6 · 2018: 2 · 2017: 4 · 2016: 8 · 2015: 9 · 2014: 12 · 2013: 14 · 2012: 13
FWCI: 12.01
Type: journal article
Language: en
Open access: closed
Locations: Journal of Clinical Psychopharmacology (publishedVersion)
PubMed (publishedVersion)
Topics: Health Sciences › Medicine › Psychiatry and Mental health › Schizophrenia research and treatment
Health Sciences › Medicine › Psychiatry and Mental health › Bipolar Disorder and Treatment
Health Sciences › Medicine › Pharmacology › Treatment of Major Depression
Keywords: asenapine, haloperidol, acute schizophrenia, antipsychotic efficacy, extrapyramidal symptoms, treatment-related adverse events, dose comparison, weight change
MeSH terms: Acute Disease, Adult, Dibenzocycloheptenes, Double-Blind Method, Female, Haloperidol, Heterocyclic Compounds, 4 or More Rings, Humans, Male, Schizophrenia, Treatment Outcome, Akathisia, Drug-Induced, Parkinsonian Disorders

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Efficacy and safety of asenapine in a placebo- and haloperidol-controlled trial in patients with acute exacerbation of schizophrenia

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