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

An Observational Post-Authorization Safety Surveillance (PASS) Study of Sycrest® (Asenapine) Among Patients Aged 18 and Older Diagnosed With Bipolar Disorder

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01495741

Enrollment

Registered

2011-12-20

Start date

2013-07-01

Completion date

2017-12-18

Last updated

2022-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar Disorder, Schizophrenia

Keywords

Mania, Manic, Depressive, Manic Depressive

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Outcome results