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

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01495741
• Other study ID #: P08307
• Secondary ID: MK-8274-110
• Status: Completed
• Start date: July 1, 2013
• Est. completion date: December 18, 2017

Study information

• Verified date: February 2022
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: December 18, 2017
• Est. primary completion date: December 18, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bipolar Disorder
• Schizophrenia

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Bipolar Disorder with Identified and Potential Clinically Important Risks	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	Approximately 1 year
Secondary	Number of Participants with Schizophrenia with Identified and Potential Clinically Important Risks	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	Approximately 1 year
Secondary	Number of Participants without Diagnoses of Schizophrenia or Bipolar Disorder with Identified and Potential Clinically Important Risks	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	Approximately 1 year

External Links

•   EU PAS Register (EUPAS17631)