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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01495741
First received: December 16, 2011
Last updated: June 19, 2014
Last verified: June 2014
  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:


Further study details as provided by Merck Sharp & Dohme Corp.:

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 ]
    When enrollment and participant exposure reaches a level that adequate power (80%) is achieved according to pre-defined power calculations, risk incidence with off-label 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 [ Time Frame: Approximately 1 year ] [ Designated as safety issue: Yes ]
    When enrollment and participant exposure reaches a level that adequate power (80%) is achieved according to pre-defined power calculations, risk incidence with off-label use of asenapine in 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: July 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 Clinical Practice Research Datalink (CPRD) 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.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01495741

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

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01495741     History of Changes
Other Study ID Numbers: P08307, MK-8274-110
Study First Received: December 16, 2011
Last Updated: June 19, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

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

Additional relevant MeSH terms:
Schizophrenia
Disease
Bipolar Disorder
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Pathologic Processes
Affective Disorders, Psychotic
Mood Disorders
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 September 18, 2014