Flexible Dose, Long-term Safety Study of Asenapine for the Treatment of Schizophrenia in Adolescents (P05897 AM2 EXT) (ADDRESS-97)
This study is designed to evaluate whether asenapine, which is a US FDA-approved acute treatment for schizophrenia in adults, is generally safe and well tolerated in adolescents with schizophrenia. This is an extension of study to P05896, which means participants must have completed participation in the 8-week study in order to qualify for this study. Participants 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.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A 26-week, Multi-center, Open-label, Flexible Dose, Long-term Safety Trial of Asenapine in Adolescent Subjects With Schizophrenia|
- Long Term Safety and Tolerability Associated with Extended Asenapine Treatment in Adolescents [ Time Frame: Through Week 26, plus a minimum of a 30-day follow up ] [ Designated as safety issue: Yes ]
|Study Start Date:||September 2010|
|Estimated Study Completion Date:||September 2013|
|Estimated Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
Participants who have previously completed Trial P05896 may enter this extension trial and receive open-label active asenapine 2.5 mg tablets or 5 mg tablets sublingually twice weekly (BID) for 26 weeks. The dose can be adjusted at the investigator's discretion based on tolerability and/or symptomatology.
asenapine 2.5 mg or 5 mg sublingually BID for 26 weeks
Other Name: Saphris®, SCH 900274, Org 5222