261410 Bleak house: A study of schizophrenia in the era of deinstitutionalization

Monday, October 29, 2012

Reuven Ferziger , Associate Director, CNS Medical Affairs, Janssen Scientific Affairs, LLC, Titusville, NJ
Lian Mao , Director, Biostatistics, Johnson & Johnson Pharmaceutical Research & Development, LLC, Titusville, NJ
Cynthia Bossie , Director, Analyses & Publications, Janssen Scientific Affairs, LLC, Titusville, NJ
Larry Alphs , Therapeutic Area Leader Psychiatry, Janssen Scientific Affairs, LLC, Titusville, NJ
Introduction: Overrepresentation of people with serious mental illness (SMI) in the criminal justice system (CJS) is an important public health problem. Yet this is a poorly studied patient population as few clinical trials specifically study SMI offenders and most operate within idealized conditions limiting eligibility. This analysis examines population characteristics in an ongoing comparative effectiveness trial of antipsychotic treatment for people with schizophrenia released from incarceration and pooled data from pivotal trials of the same drug conducted for regulatory approval.

Methods: Sample 1 (NCT01157351) from an ongoing 15-month randomized, open-label, multicenter US study comparing paliperidone palmitate with oral antipsychotics in a community sample of subjects with schizophrenia released from incarceration. Sample 2 is pooled data from completed short-term, randomized double-blind international studies of paliperidone palmitate in subjects with schizophrenia. Descriptive statistics evaluated baseline demographics and clinical characteristics of enrolled subjects. Two sample t-tests and chi-square tests used to compare groups. No adjustments made for multiplicity.

Results: Statistically significant differences (P<=.01) between samples 1 (n=280) and 2 (N=1803) included mean (SD) age (37.2 [10.3] vs 39.8 [10.8] y), sex (percentage males, 87.9% vs 67.6%); race (percentage African Americans, 62.9% vs 30.5%); mean (SD) age of first psychiatric diagnosis (19.7 [7.3] vs 25.7 [8.5] y); and severity of illness (percentage borderline or mildly ill at study entry via CGI-S score, 33.7% vs 3.6%).

Conclusion: Baseline data from these two schizophrenia samples differed in several categories. The relationship to outcomes parameters will be explored.

Learning Areas:
Clinical medicine applied in public health
Other professions or practice related to public health

Learning Objectives:
Compare baseline demographics and clinical characteristics of patients with schizophrenia who were in vs who were not in the criminal justice system

Keywords: Criminal Justice, Mental Health

Presenting author's disclosure statement:

Qualified on the content I am responsible for because: I am the clinical trial leader of a large multicenter study comparing the effectiveness of a long-acting antipsychotic vs oral antipsychotics in individuals with schizophrenia who have been recently released from incarceration. I also have extensive experience in the field of psychiatry focusing on schizophrenia, bipolar disorder, dementia, autism, and epilepsy. My interests particularly focus on mental Health Policy in national, federal, advocacy, and policy research sectors.
Any relevant financial relationships? Yes

Name of Organization Clinical/Research Area Type of relationship
Janssen Scientific Affairs CNS Medical Affairs Employment (includes retainer), Owns stocks with J&J and Stock Ownership

I agree to comply with the American Public Health Association Conflict of Interest and Commercial Support Guidelines, and to disclose to the participants any off-label or experimental uses of a commercial product or service discussed in my presentation.

Back to: 3403.0: Mental health in the workplace and systems of care