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Cited by 189

The DOI matches its Crossref record; 11 of the 11 references it cites were found in a registry or an index.

A 3‐week, randomized, placebo‐controlled trial of asenapine in the treatment of acute mania in bipolar mania and mixed states

McIntyre, Roger S, Cohen, Miriam, Zhao, Jun, Alphs, Larry, Macek, Thomas A, Panagides, John·2009·Bipolar Disorders
DOI 10.1111/j.1399-5618.2009.00748.x
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Abstract

Objective: Asenapine is approved for bipolar disorder and schizophrenia. This was a 3‐week, randomized, double‐blind, placebo‐controlled trial of asenapine for treating acute bipolar mania. Methods: After a single‐blind placebo run‐in period, adults (n = 488) experiencing manic or mixed episodes were randomized to flexible‐dose sublingual asenapine (10 mg BID on day 1; 5 or 10 mg BID thereafter; n = 194), placebo (n = 104), or oral olanzapine (15 mg BID on day 1; 5–20 mg QD thereafter; n = 191). Primary efficacy, change in Young Mania Rating Scale (YMRS) total score from baseline to day 21, was assessed using analysis of covariance with last observation carried forward [(LOCF); primary analysis]. A mixed model for repeated measures [(MMRM); prespecified secondary analysis] was also used to assess efficacy. Tolerability and safety assessments included adverse events, physical examinations, extrapyramidal symptom ratings, and laboratory values. Results: Mean daily dosages were asenapine 18.2 mg and olanzapine 15.8 mg. Significantly greater least squares (LS) mean ± SE changes in YMRS scores were observed on day 2 with asenapine (−3.0 ± 0.4) and olanzapine (−3.4 ± 0.4) versus placebo (−1.5 ± 0.5, both p < 0.01) and were maintained until day 21 (−10.8 ± 0.8 with asenapine, −12.6 ± 0.8 with olanzapine; both p ≤ 0.0001 versus placebo, −5.5 ± 1.1) with LOCF. The results of MMRM analyses were consistent with those of LOCF. Asenapine had a modest impact on weight and metabolic measures. Conclusions: These results indicate that asenapine is rapidly acting, efficacious, and well tolerated for patients with bipolar I disorder experiencing an acute manic episode.

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Metadata

Authors
McIntyre, R. S., Cohen, M., Zhao, J., Alphs, L., Macek, T. A., & Panagides, J.
Venue
Bipolar Disorders
Publisher
Wiley
Published
2009-10-14
Volume
11
Issue
7
Pages
673-686
ISSN
  • 1398-5647 (ISSN-L)
  • 1399-5618
DOI
10.1111/j.1399-5618.2009.00748.x
OpenAlex
W1967358491
Cited by
189
References
11
FWCI
14.77
Type
journal article
Language
en
Open access
closed

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CoChat. (2026). Citation check: A 3‐week, randomized, placebo‐controlled trial of asenapine in the treatment of acute mania in bipolar mania and mixed states. https://app.cochat.ai/papers/10.1111/j.1399-5618.2009.00748.x
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McIntyre, R. S., Cohen, M., Zhao, J., Alphs, L., Macek, T. A., & Panagides, J. (2009). A 3‐week, randomized, placebo‐controlled trial of asenapine in the treatment of acute mania in bipolar mania and mixed states. Bipolar Disorders. https://doi.org/10.1111/j.1399-5618.2009.00748.x

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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).

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