Conditions: Schizophrenia
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 532
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Participants received a 5 mg asenapine fast dissolving tablet twice daily (BID) for 6 weeks. arm 2: Participants received a 5 mg asenapine fast dissolving tablet BID on Day 1, then 10 mg asenapine fast dissolving tablet BID thereafter for a total of 6 weeks. arm 3: Participants received matching placebo BID for 6 weeks.

Interventions: intervention 1: Asenapine 5 mg intervention 2: Asenapine 10 mg intervention 3: Placebo
Intervention descriptions: intervention 1: Asenapine 5 mg fast dissolving tablets sublingually without water twice daily, in the morning (around 8 am) and in the evening (around 8 pm), on Day 1 only or for 6 weeks. intervention 2: Participants receive on Day 2, 10 mg BID of fast dissolving tablets sublingually without water twice daily, in the morning (around 8 am) and in the evening (around 8 pm), for 6 weeks. intervention 3: A matching placebo of asenapine sublingual tablet not containing asenapine

Protocol document: