At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An 8-week, Placebo-controlled, Double-blind, Randomized, Fixed-dose Efficacy and Safety Trial of Asenapine in Adolescent Subjects With Schizophrenia
In Brief
A Phase 3 clinical trial evaluating asenapine 2.5 mg, asenapine 5.0 mg, and 1 other intervention for Schizophrenia, Paranoid and 2 related conditions. Completed, enrolled 306 participants.
Detailed 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.
Study Details
Timeline
Interventions
asenapine 2.5 mg tablets for sublingual administration
asenapine 5.0 mg tablets for sublingual administration
asenapine-matched placebo tablets for sublingual administration