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

Brief Summary

Official Title: “An Observational Post-Authorization Safety Surveillance (PASS) Study of Sycrest® (Asenapine) Among Patients Aged 18 and Older Diagnosed With Bipolar Disorder”

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 of identified and potential clinically important risks will also be assessed.

  • Study Type: Observational
  • Study Design: Observational Model: Cohort, Time Perspective: Retrospective
  • Study Primary Completion Date: January 2015

Arms, Groups and Cohorts in this Clinical Trial

  • Asenapine
    • Participants prescribed asenapine
  • Risperidone Comparator
    • Participants prescribed risperidone
  • Olanzapine Comparator
    • Participants prescribed olanzapine

Outcome Measures for this Clinical Trial

Primary Measures

  • Number of Participants with Bipolar Disorder with Identified and Potential Clinically Important Risks
    • Time Frame: Approximately 1 year
      Safety Issue?: Yes

Secondary Measures

  • Number of Participants with Schizophrenia with Identified and Potential Clinically Important Risks
    • Time Frame: Approximately 1 year
      Safety Issue?: Yes
  • Number of Participants without Diagnoses of Schizophrenia or Bipolar Disorder with Identified and Potential Clinically Important Risks
    • Time Frame: Approximately 1 year
      Safety Issue?: Yes

Criteria for Participation in this Clinical Trial

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

  • Lead Sponsor
    • Merck Sharp & Dohme Corp.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Medical Director, Study Director, Merck Sharp & Dohme Corp.

Source

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT01495741