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

P05897

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.

2010-09-28

2013-10-07

2013-10-07

Completed

Early phase I

204

Inclusion Criteria: * Each participant must be between 12 and 17 years of age at the time of entry on this study, however, participants in the 8-week base study (P05896 \[NCT01190254\]) who reach 18 years of age while on P05896 may be enrolled in this extension study provided all other inclusion/exclusion criteria are met. * Must have completed the 8-week efficacy and safety trial (P05896 \[NCT01190254\]) and, according to the investigator's judgment, would benefit from long-term treatment. * Must have demonstrated an acceptable degree of compliance with trial medication, visits, and other requirements in the 8-week trial (P05896 \[NCT01190254\]), in the opinion of the investigator. Exclusion Criteria: * A female participant must not be pregnant and must not have the intention to become pregnant during the trial. * A participant must not be at imminent risk of self-harm or harm to others. * A participant must not currently be under involuntary inpatient commitment.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 204, 'type': 'ACTUAL'}}

2024-05-22