NCT01190254

Fixed Dose Efficacy and Safety Study of Asenapine for the Treatment of Schizophrenia in Adolescents (P05896)

An 8-week, Placebo-controlled, Double-blind, Randomized, Fixed-dose Efficacy and Safety Trial of Asenapine in Adolescent Subjects With Schizophrenia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 306 (actual)
• Sponsor: Organon and Co · Industry
• Sex: All
• Age: 12 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Schizophrenia, Paranoid
• Schizophrenia, Disorganized
• Schizophrenia, Undifferentiated

Interventions

Type	Name	Description
DRUG	asenapine 2.5 mg	asenapine 2.5 mg tablets for sublingual administration
DRUG	asenapine 5.0 mg	asenapine 5.0 mg tablets for sublingual administration
DRUG	placebo	asenapine-matched placebo tablets for sublingual administration

Timeline

• Start date: 2010-09-28
• Primary completion: 2013-03-10
• Completion: 2013-04-01
• First posted: 2010-08-27
• Last updated: 2024-05-21
• Results posted: 2014-06-06