Conditions: Bipolar Disorder
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 326
Healthy volunteers: no

Brief summary:
This is a 12-week study that will test the safety and efficacy of asenapine when used in addition to lithium or valproate for subjects with acute manic or mixed episodes of Bipolar I Disorder.

Detailed description:

Arms:
arm 1: Participants received asenapine as a fast-dissolving sublingual (SL) tablet, given twice daily (BID). On Day 1, participants received asenapine 5 mg, BID. On Days 2 to 84, asenapine was dosed flexibly: BID at either 5 or 10 mg. Asenapine doses were up- or down-titrated based on efficacy, safety, and tolerability. arm 2: Participants received placebo on Days 1-84 as a fast-dissolving SL tablet, BID.

Interventions: intervention 1: Asenapine intervention 2: Placebo
Intervention descriptions: intervention 1: Asenapine fast dissolving SL tablets 5 and 10 mg; starting dose 5 mg BID on Day 1; 5-10 mg BID after Day 1. intervention 2: Placebo fast dissolving SL tablets, BID

Protocol document: