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

Sponsor
Organon and Co (Industry)
Overall Status
Completed
CT.gov ID
NCT01495741
Collaborator
(none)
42
53.6

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    42 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    An Observational Post-Authorization Safety Surveillance (PASS) Study of Sycrest® (Asenapine) Among Patients Aged 18 and Older Diagnosed With Bipolar Disorder
    Actual Study Start Date :
    Jul 1, 2013
    Actual Primary Completion Date :
    Dec 18, 2017
    Actual Study Completion Date :
    Dec 18, 2017

    Arms and Interventions

    Arm Intervention/Treatment
    Asenapine

    Participants prescribed asenapine

    Risperidone Comparator

    Participants prescribed risperidone

    Olanzapine Comparator

    Participants prescribed olanzapine

    Outcome Measures

    Primary Outcome Measures

    1. Number of Participants with Bipolar Disorder with Identified and Potential Clinically Important Risks [Approximately 1 year]

      Identified and potential clinically important risks will include: extrapyramidal symptoms, somnolence and sedation, neuroleptic malignant syndrome, rhabdomyolysis, seizure, hyperprolactinaemia, orthostatic hypotension, neutropenia, allergic reactions, dyslipidaemia and diabetes mellitus with the use of asenapine versus risperidone or olanzapine

    Secondary Outcome Measures

    1. Number of Participants with Schizophrenia with Identified and Potential Clinically Important Risks [Approximately 1 year]

      When enrollment and participant exposure reaches a level that adequate power (80%) is achieved according to pre-defined power calculations, risk incidence with use of asenapine in participants diagnosed with schizophrenia with no prior and/or concomitant diagnosis of bipolar disorder will be analyzed. Identified and potential clinically important risks will include: extrapyramidal symptoms, somnolence and sedation, neuroleptic malignant syndrome, rhabdomyolysis, seizure, hyperprolactinaemia,orthostatic hypotension, neutropenia, allergic reactions, dyslipidaemia and diabetes mellitus with the use of asenapine versus risperidone or olanzapine

    2. Number of Participants without Diagnoses of Schizophrenia or Bipolar Disorder with Identified and Potential Clinically Important Risks [Approximately 1 year]

      When enrollment and participant exposure reaches a level that adequate power (80%) is achieved according to pre-defined power calculations, risk incidence with use of asenapine in participants with no prior and/or concomitant diagnoses of bipolar disorder or schizophrenia, but diagnosed with i) Alzheimer's disease, ii) other diagnoses - mental disorders or iii) no diagnosis, will be analyzed. Identified and potential clinically important risks will include: extrapyramidal symptoms, somnolence and sedation, neuroleptic malignant syndrome, rhabdomyolysis, seizure, hyperprolactinaemia,orthostatic hypotension, neutropenia, allergic reactions, dyslipidaemia and diabetes mellitus with the use of asenapine

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Organon and Co

    Investigators

    • Study Director: Medical Director, Merck Sharp & Dohme LLC

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Organon and Co
    ClinicalTrials.gov Identifier:
    NCT01495741
    Other Study ID Numbers:
    • P08307
    • MK-8274-110
    First Posted:
    Dec 20, 2011
    Last Update Posted:
    Feb 4, 2022
    Last Verified:
    Feb 1, 2022
    Keywords provided by Organon and Co
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 4, 2022