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

Organon

Status: Completed

Conditions: Schizophrenia; Bipolar Disorder

Study type: Observational

Funder types: Industry

Identifiers

NCT01495741

MK-8274-110 (Other Identifier)

P08307

Details and patient eligibility

About

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.

Enrollment: 42 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

42 participants in 3 patient groups

Asenapine

Description:

Participants prescribed asenapine

Risperidone Comparator

Description:

Participants prescribed risperidone

Olanzapine Comparator

Description:

Participants prescribed olanzapine