Clinical Trials Directory

Trials / Completed

CompletedNCT01495741

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
Phase
Study type
Observational
Enrollment
42 (actual)
Sponsor
Organon and Co · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Timeline

Start date
2013-07-01
Primary completion
2017-12-18
Completion
2017-12-18
First posted
2011-12-20
Last updated
2022-02-04

Source: ClinicalTrials.gov record NCT01495741. Inclusion in this directory is not an endorsement.