6-week Trial of the Efficacy and Safety of Asenapine Compared to Placebo in Participants With an Acute Exacerbation of Schizophrenia (P06124)

Phase 3 Completed 532 enrolled Organon and Co

RandomizedParallel-groupDouble-blindTreatment

Summary

A multicenter, randomized, parallel-group, double-blind, fixed dose, 6-week trial of the efficacy and safety of asenapine compared with placebo in participants with an acute exacerbation of schizophrenia.

Timeline

Start: 2010-05-25
Primary completion: 2014-04-14
Completion: 2014-04-14

Outcome

Met primary endpoint

paper The primary endpoint was significantly greater with asenapine 5 and 10 mg bid than with placebo (-12.24 and -14.17 vs. -0.95; p < 0.0001). PMID 27271087 ↗

registry Asenapine 5 mg BID vs Placebo BID; p <0.0001; Least square (LS) means difference -11.29 (95% CI -15.42 to -7.16) NCT01098110 ↗

Publications

Results Kinoshita T, Bai YM, Kim JH, Miyake M, Oshima N. Efficacy and safety of asenapine in Asian patients with an acute exacerbation of schizophrenia: a multicentre, randomized, double-blind, 6-week, placebo-controlled study. Psychopharmacology (Berl). 2016 Jul;233(14):2663-74. doi: 10.1007/s00213-016-4295-9. Epub 2016 Jun 8.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Asenapine	Other / unclassified	5 mg	Other
Subject	Asenapine	Other / unclassified	10 mg	Other