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

NCT ID: NCT03390712

Last Updated: 2018-01-04

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 328 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-01-02
• Study Completion Date: 2018-12-31

Brief 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

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: RETROSPECTIVE

Study Groups

Paliperidone Palmitate

Patients who have received a minimum of 3 months of treatment with an injection of paliperidone palmitate.

Paliperidone Palmitate

Intervention Type: DRUG

Monthly injections

Antipsychotic

Intervention Type: DRUG

Any oral antipsychotic prescribed to be taken on a regular basis prior to the initiation of a long-acting injectable antipsychotic.

Risperidone Long-acting injection.

Patients who have received a minimum of 3 months of treatment with Risperidone long-acting injection.

Risperidal Consta

Intervention Type: DRUG

Bi-weekly injection

Antipsychotic

Intervention Type: DRUG

Any oral antipsychotic prescribed to be taken on a regular basis prior to the initiation of a long-acting injectable antipsychotic.

Interventions

Paliperidone Palmitate

Monthly injections

Intervention Type: DRUG

Risperidal Consta

Bi-weekly injection

Intervention Type: DRUG

Antipsychotic

Any oral antipsychotic prescribed to be taken on a regular basis prior to the initiation of a long-acting injectable antipsychotic.

Intervention Type: DRUG

Other Intervention Names

Invega Sustenna; Risperidone long-acting injection; Oral antipsychotics

Eligibility Criteria

Inclusion Criteria

• Patients who were initiated on either Risperidone long-acting injection or Paliperidone palmitate during an acute psychiatric admission for schizophrenia or other psychotic related disorders.

Exclusion Criteria

• Patients who had their long-acting injection stopped prior to the discharge date of their index admission.
• Patients who received a long-acting injection in the year prior to the index admission.
• Patients who had a psychiatric admission to a forensic, rehabilitation or high dependency unit during the observation period prior to or following their index admission.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Inc.

INDUSTRY

Sponsor Role: collaborator

Réseau de Santé Vitalité Health Network

OTHER

Sponsor Role: lead

Responsible Party

Michael Kemp

Psychiatric Pharmacist and Clinical Researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Chaleur Regional Hospital

Bathurst, New Brunswick, Canada

Campbellton Regional Hospital

Campbellton, New Brunswick, Canada

Edmundston Regional Hospital

Edmundston, New Brunswick, Canada

Dr. George-L.-Dumont University Hospital Center

Moncton, New Brunswick, Canada

Countries

Canada

Other Identifiers

PHAR-1701

Identifier Type: -

Identifier Source: org_study_id