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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2016 by Merck Sharp & Dohme Corp.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01495741
First received: December 16, 2011
Last updated: July 8, 2016
Last verified: July 2016
  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 Phase
Bipolar Disorder
Schizophrenia
Phase 4

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 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 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


Estimated Enrollment: 3000
Study Start Date: July 2013
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (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   (Adult, Senior)
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 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
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

Contacts
Contact: Toll Free number 1-888-577-8839

Locations
United Kingdom
Merck Sharp & Dohme Ltd. Recruiting
Hoddesdon, United Kingdom
Contact: Mark Toms    +44 (0) 1992 452475      
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 
Study First Received: December 16, 2011
Last Updated: July 8, 2016
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:
Disease
Schizophrenia
Bipolar Disorder
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Bipolar and Related Disorders
Risperidone
Asenapine
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on August 29, 2016