Status:

COMPLETED

Post-Authorization Safety Surveillance Study of Asenapine in Participants With Bipolar Disorder (P08307)

Lead Sponsor:

Organon and Co

Conditions:

Bipolar Disorder

Schizophrenia

Eligibility:

All Genders

18+ years

Brief Summary

This study will assess asenapine (Sycrest®) use in participants with bipolar disorder; comparison will be made to the use of risperidone (RISPERDAL®CONSTA®) and olanzapine (Zyprexa®). The occurrence o...

Eligibility Criteria

Inclusion

  • Inclusion Criteria for the Bipolar Disease Cohort:
  • A diagnosis of Bipolar Disorder
  • Exclusion Criteria for the Bipolar Disease Cohort:
  • None
  • Inclusion Criteria for the potential Schizophrenia Cohort:
  • A diagnosis of schizophrenia
  • Exclusion Criteria for the potential Schizophrenia Cohort:
  • A prior and/or concomitant diagnosis of bipolar disease

Exclusion

    Key Trial Info

    Start Date :

    July 1 2013

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ACTUAL

    End Date :

    December 18 2017

    Estimated Enrollment :

    42 Patients enrolled

    Trial Details

    Trial ID

    NCT01495741

    Start Date

    July 1 2013

    End Date

    December 18 2017

    Last Update

    February 4 2022

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