Conditions: Schizophrenia, Paranoid Schizophrenia, Disorganized Schizophrenia, Undifferentiated
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 204
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 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.

Detailed description:

Arms:
arm 1: All enrolled participants receive open-label asenapine 2.5 mg twice daily (BID) on Day 1-3, which is increased to 5.0 mg BID on Day 4 (dose can be increased earlier at the investigator's discretion). Asenapine dosing is flexible for the remainder of the 26-week open-label drug administration period, and can be adjusted to either 2.5 mg or 5.0 mg BID at the investigator's discretion, based on tolerability and/or symptomatology.

Interventions: intervention 1: asenapine
Intervention descriptions: intervention 1: asenapine 2.5 mg or 5.0 mg sublingual tablets, administered BID

Protocol document: