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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01495741
Recruitment Status : Completed
First Posted : December 20, 2011
Last Update Posted : January 8, 2018
Sponsor:
Information provided by (Responsible Party):

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
Bipolar Disorder Schizophrenia

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 : July 1, 2013
Primary Completion Date : December 18, 2017
Study Completion Date : December 18, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Participants with Bipolar Disorder codes who are included in the United Kingdom Clinical Practice Research Datalink (CPRD) and, if required, The Health Improvement Network (THIN) database.

If pre-specified sample size and exposure criteria are met, secondary objectives will be conducted in 2 separate study populations: 1. Participants treated with asenapine and diagnosed with schizophrenia and no prior and/or concomitant diagnosis of bipolar disorder; 2. Participants treated with asenapine 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.

Criteria

Inclusion Criteria for the Bipolar Disease Cohort:

  • A diagnosis of Bipolar Disorder

Exclusion Criteria for the Bipolar Disease Cohort:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01495741


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Director Merck Sharp & Dohme Corp.
More Information

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01495741     History of Changes
Other Study ID Numbers: P08307
MK-8274-110 ( Other Identifier: Merck )
First Posted: December 20, 2011    Key Record Dates
Last Update Posted: January 8, 2018
Last Verified: January 2018

Keywords provided by Merck Sharp & Dohme Corp.:
Mania
Manic
Depressive
Manic Depressive

Additional relevant MeSH terms:
Disease
Schizophrenia
Bipolar Disorder
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Bipolar and Related Disorders
Asenapine
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs