Status:
COMPLETED
Research and Evaluation of Antipsychotic Treatment in Community Behavioral Health Organizations
Lead Sponsor:
Janssen Scientific Affairs, LLC
Conditions:
Schizophrenia
Bipolar Disorder
Eligibility:
All Genders
18-64 years
Brief Summary
The purpose of this study is to build a data repository that can be used to understand pharmaceutical utilization patterns among patients being treated in community behavioral health organizations (CB...
Detailed Description
This is a prospective observational study of usual care of patients undergoing treatment for schizophrenia or bipolar I disorder at CBHOs. Up to 50 CBHOs will be selected as sites for this study. Trea...
Eligibility Criteria
Inclusion
- Diagnosed with schizophrenia or bipolar I disorder
- Antipsychotic use in one of the following categories: Clinician ordered initiation of Risperidone long acting injectable in the 4 weeks prior to or on the day of enrollment (includes patients not previously on any antipsychotic medication and those switched from another antipsychotic)
- On continuous Risperidone long acting injectable for at least 6 months prior to enrollment (no gaps between injections\>30 days)
- Clinician ordered initiation of Paliperidone Palmitate in the 4 weeks prior to or on the day of enrollment (includes patients not previously on any antipsychotic medication and those switched from another antipsychotic)
- or on continuous Paliperidone Palmitate for any time period prior to enrollment
- Clinician ordered initiation of another antipsychotic in the 4 weeks prior to or on the day of enrollment (includes patients not previously on any antipsychotic medication and those switched from another antipsychotic)
- Not enrolled in another clinical study
- Primary source of care for schizophrenia or bipolar I disorder is the recruiting CBHO
- Agrees to all study procedures/interviews
- must sign the study informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study
Exclusion
- Currently participating in a clinical study (e.g. clinical trial or observational study) or participated in a clinical study within the past 30 days
Key Trial Info
Start Date :
August 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
1066 Patients enrolled
Trial Details
Trial ID
NCT01181960
Start Date
August 1 2010
End Date
November 1 2013
Last Update
February 12 2014
Active Locations (34)
Enter a location and click search to find clinical trials sorted by distance.
1
Neuropsychiatry Clinic and Research Center
Bullhead City, Arizona, United States, 86442
2
Shanti Clinical Trials
Colton, California, United States, 92324
3
Sun Valley Research Center
Imperial, California, United States, 92251
4
South Coast Clinical Trials, Inc.
Norwalk, California, United States, 90650