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In (1) on p. 673, there are errors in the ‘Methods’ and ‘Results’ sections of the Abstract. On lines 1 and 4 of the ‘Methods’, the terms ‘n = 488’ and ‘BID’ should be ‘n = 489’ and ‘QD’, respectively. The correct sentence is: ‘After a single-blind placebo run-in period, adults (n = 489) 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 QD on day 1; 5–20 mg QD thereafter; n = 191). On line 7 of the ‘Results’, the term ‘−5.5 ± 1.1’ should be ‘−5.5 ± 1.0’. The correct sentence is: ‘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 ± 1.0) with LOCF.’

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 = 489) 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 QD 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 ± 1.0) 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.

In (1) on p. 678, there is an error in the ‘YMRS total score’ section of the Results. On line 8 of this section, the term ‘−5.5 ± 10’ should be ‘−5.5 ± 1.0’. The correct sentence is: ‘With LOCF analysis, the LS mean ± SE changes from baseline to day 21 were significantly greater with asenapine (−10.8 ± 0.8) and olanzapine (−12.6 ± 0.8) compared with placebo (−5.5 ± 1.0, both p < 0.0001 versus placebo; Fig. 2, Table 2).’

In (1) on p. 681, there is an error in the ‘CGI-BP mania severity’ section of the Results. On lines 4 and 5 in column 1 of page 681, the terms ‘−1.2 ± 0.01’ and ‘−1.4 ± 0.01’ should be ‘−1.2 ± 0.1’ and ‘−1.4 ± 0.1’, respectively. The correct sentence is: ‘Using LOCF analysis, LS mean ± SE changes from baseline to day 21 were −1.2 ± 0.1 with asenapine (p < 0.002 versus placebo), −1.4 ± 0.1 with olanzapine (p < 0.0001 versus placebo), and −0.7 ± 0.1 with placebo.’

In (1) on p. 683, there are errors in Table 4 under the ‘Vital signs’ section. For the change in sitting systolic blood pressure for placebo and olanzapine, the terms ‘0.2 ± 9.9’ and ‘1.0 ± 3.2’ should be ‘−1.2 ± 13.4’ and ‘−0.1 ± 12.2’, respectively. For the change in sitting diastolic blood pressure for asenapine and olanzapine, the terms ‘−1.2 ± 13.4’ and ‘0.1 ± 3.2’ should be ‘0.2 ± 9.9’ and ‘−0.2 ± 9.1’, respectively.

We apologize for these errors.

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