Conditions: Schizophrenia, Paranoid Schizophrenia, Disorganized Schizophrenia, Undifferentiated
Keywords: Asenapine adolescents schizophrenia phase IIIb placebo-controlled
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 306
Healthy volunteers: no

Brief summary:
This study is designed to evaluate whether asenapine, which is approved by the United States Food and Drug Administration (US FDA) for acute treatment of schizophrenia in adults, is also effective in adolescents with schizophrenia. Participants who qualify for the study will be randomly assigned to receive a fixed dose of asenapine (either 2.5 mg or 5 mg twice daily \[BID\]) or placebo for 8 weeks. Throughout the study, observations will be made on each participant at various times to assess the efficacy and safety of the study treatment. The primary objective of the trial is to demonstrate significant superiority of at least one asenapine dose to placebo, as measured by the change from baseline of the Positive and Negative Syndrome Scale (PANSS) total score at Day 56.

Detailed description:

Arms:
arm 1: Participants receive active asenapine 2.5 mg tablets sublingually BID for 8 weeks. arm 2: Participants receive active asenapine 2.5 mg tablets sublingually BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive active asenapine 5.0 mg tablets sublingually BID for the remainder of the 8-week treatment period. arm 3: Participants receive placebo asenapine tablets sublingually BID for 8 weeks.

Interventions: intervention 1: asenapine 2.5 mg intervention 2: asenapine 5.0 mg intervention 3: placebo
Intervention descriptions: intervention 1: asenapine 2.5 mg tablets for sublingual administration intervention 2: asenapine 5.0 mg tablets for sublingual administration intervention 3: asenapine-matched placebo tablets for sublingual administration

Protocol document: