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Clinical Trial 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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT01190267
Study type Interventional
Source Organon and Co
Contact
Status Completed
Phase Phase 3
Start date September 28, 2010
Completion date October 7, 2013

See also
  Status Clinical Trial Phase
Completed NCT01190254 - Fixed Dose Efficacy and Safety Study of Asenapine for the Treatment of Schizophrenia in Adolescents (P05896) Phase 3
Recruiting NCT00563017 - Evaluation of Efficacy and Safety of Long-acting Risperidone Microspheres in Patients With Schizophrenia or Other Psychotic Disorders When Switching From Typical Antipsychotic (Oral/Depot) or Atypical Oral Other Than Risperidone N/A