NCT01190267

Flexible Dose, Long-term Safety Study of Asenapine for the Treatment of Schizophrenia in Adolescents (P05897)

A 26-week, Multi-center, Open-label, Flexible Dose, Long-term Safety Trial of Asenapine in Adolescent Subjects With Schizophrenia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 204 (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 generally safe and well tolerated in adolescents with schizophrenia. This is an extension of base study P05896 (NCT01190254), which means participants must have completed participation in the 8-week base study in order to qualify for this extension study P05897. Participants in this extension study will receive open-label asenapine for 26 weeks. Throughout the study, observations will be made on each participant at various times to assess the long-term safety, tolerability and efficacy of the study treatment.

Conditions

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

Interventions

Type	Name	Description
DRUG	asenapine	asenapine 2.5 mg or 5.0 mg sublingual tablets, administered BID

Timeline

• Start date: 2010-09-28
• Primary completion: 2013-10-07
• Completion: 2013-10-07
• First posted: 2010-08-27
• Last updated: 2024-05-22
• Results posted: 2014-08-06