28-30 Month Study Comparing Paliperidone Palmitate With Oral Risperidone for Treating Adults Diagnosed With Schizophrenia Within the Past 5 Years

Schizophrenia Clinical Trial

Official title: A Prospective, Randomized, Active-controlled, Rater-blinded Study of the Prevention of Relapse Comparing Paliperidone Palmitate With Oral Risperidone in Adults With Recently-Diagnosed Schizophrenia Who Are at High Risk of Relapse

Status Terminated

Clinical Trial Summary

The study will assess the use of paliperidone palmitate compared with oral risperidone in delaying time to relapse in patients recently diagnosed with schizophrenia who are at high risk of relapse.

Clinical Trial Description

This is a Prospective, Randomized, Active-controlled, Rater-blinded Study to to assess the efficacy of paliperidone palmitate compared with oral risperidone in delaying time to relapse in patients recently diagnosed with schizophrenia who are at high risk of relapse. Recently diagnosed is defined as first diagnosis of any psychotic disorder within 5 years prior to screening. High risk of relapse is defined as having documented occurrence of 3 periods of breakthrough symptoms that required a change in patient care per the investigator's judgment (e.g., increase in dose, addition of a new drug, increase in the level of psychiatric care, notable increases in the frequency or intensity of patient contact required to maintain outpatient status, psychiatric hospitalization, etc.) within the previous 24 months, including 1 such period within the previous 6 months. Safety evaluations will include Adverse Event (AE) reporting, hematology and clinical chemistry laboratory tests, vital signs, electrocardiogram (ECG), and evaluations of suicidality and sexual functioning. Patients will receive either paliperidone palmitate 50, 75, 100, or 150 mg eq. monthly by injection for two years or oral risperidone 2, 4, 6, or 8 mg tabs once daily for two years. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Schizophrenia

• NCT number: NCT00946985
• Study type: Interventional
• Source: Ortho-McNeil Janssen Scientific Affairs, LLC
• Status: Terminated
• Phase: Phase 4
• Start date: June 2009
• Completion date: March 2010