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Post-Authorization Safety Surveillance Study of Asenapine in Participants With Bipolar Disorder (P08307 AM2)

This study is not yet open for participant recruitment.
Verified May 2013 by Merck
Sponsor:
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT01495741
First received: December 16, 2011
Last updated: May 8, 2013
Last verified: May 2013
History of Changes
  Purpose

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
Bipolar Disorder
Schizophrenia

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

Drug Information available for: Asenapine
U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • Number of Participants with Bipolar Disorder with Identified and Potential Clinically Important Risks [ Time Frame: Approximately 1 year ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Approximately 1 year ] [ Designated as safety issue: Yes ]

    If pre-specified sample size and exposure criteria for off-label use are met, 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 [ Time Frame: Approximately 1 year ] [ Designated as safety issue: Yes ]

    If pre-specified sample size and exposure criteria for off-label use are met, participants with no prior and/or concomitant diagnoses of bipolar disorder or schizophrenia 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



Estimated Enrollment: 3000
Study Start Date: September 2013
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Asenapine
Participants prescribed asenapine
Risperidone Comparator
Participants prescribed risperidone
Olanzapine Comparator
Participants prescribed olanzapine

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

If pre-specified sample size and exposure criteria for off-label use 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. If sample size for off-label use is not achieved, level of off-label use required to trigger a secondary analysis will be reconsidered at year 3.

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
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck
ClinicalTrials.gov Identifier: NCT01495741     History of Changes
Other Study ID Numbers: P08307
Study First Received: December 16, 2011
Last Updated: May 8, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Merck:
Mania
Manic
Depressive
Manic Depressive

Additional relevant MeSH terms:
Bipolar Disorder
Schizophrenia
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
Asenapine
Antipsychotic Agents
 Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on May 16, 2013