Design and Rationale of the Paliperidone Palmitate Research in Demonstrating Effectiveness (PRIDE) Study: A Novel Comparative Trial of Once-Monthly Paliperidone Palmitate Versus Daily Oral Antipsychotic Treatment for Delaying Time to Treatment Failure in Persons With Schizophrenia

摘要

Background: Public health considerations require that clinical trials address the complex "real-world" needs of patients with chronic illnesses. This is particularly true for persons with schizophrenia, whose management is frequently complicated by factors such as comorbid substance abuse, homelessness, and contact with the criminal justice system. In addition, barriers to obtaining health care in the United States often prevent successful community reentry and optimal patient management. Further, nonadherence to treatment is common, and this reinforces cycles of relapse and recidivism.