Post-Authorization Safety Surveillance Study of Asenapine in Participants With Bipolar Disorder (P08307)
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 |
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Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Asenapine Participants prescribed asenapine |
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Risperidone Comparator Participants prescribed risperidone |
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Olanzapine Comparator Participants prescribed olanzapine |
Outcome Measures
Primary Outcome Measures
- 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
- 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
- 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
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.- P08307
- MK-8274-110