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

NCT03390712 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 328

Last updated 2018-01-04

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Janssen Inc.

    collaborator INDUSTRY

  • Réseau de Santé Vitalité Health Network

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-02
Primary Completion
2018-09-30
Completion
2018-12-31
FDA Drug
Yes

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03390712 on ClinicalTrials.gov