NCT03390712

Mirror-image Study of Paliperidone Palmitate and Risperidone Long-acting Injection

Mirror-image Study Exploring Relapse and Resource Utilization of Paliperidone Palmitate and Risperidone Long-acting Injection in Vitalité Health Network Patients

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 328 (estimated)
• Sponsor: Réseau de Santé Vitalité Health Network · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: —

Summary

The primary objective of this single-center multi-site retrospective chart review is to determine if paliperidone palmitate and/or risperidone long-acting injection can decrease the number of psychiatric relapses following their initiation in an inpatient acute psychiatric unit compared to oral antipsychotic therapy and determine if one treatment is superior to the other in this regard. This study will utilize a mirror-image design and incorporate up to a 3 years of follow-up following the index admission. Secondary objectives of this study will be to determine the change in hospital resource utilization for psychiatric reasons following treatment initiation, and to determine the difference in time to relapse.

Conditions

• Schizophrenia Spectrum and Other Psychotic Disorders

Interventions

Type	Name	Description
DRUG	Paliperidone Palmitate	Monthly injections
DRUG	Risperidal Consta	Bi-weekly injection
DRUG	Antipsychotic	Any oral antipsychotic prescribed to be taken on a regular basis prior to the initiation of a long-acting injectable antipsychotic.

Timeline

• Start date: 2018-01-02
• Primary completion: 2018-09-01
• Completion: 2018-12-01
• First posted: 2018-01-04
• Last updated: 2018-01-04

Locations

4 sites across 1 country: Canada

Regulatory

• FDA-regulated drug study