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

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.

Study Overview

• Status: Unknown
• Conditions: Schizophrenia Spectrum and Other Psychotic Disorders
• Intervention / Treatment: Drug: Paliperidone Palmitate; Drug: Antipsychotic; Drug: Risperidal Consta

• Study Type: Observational
• Enrollment (Anticipated): 328

Contacts and Locations

Study Locations

• Canada
  • New Brunswick
    • Bathurst, New Brunswick, Canada, E2A 4L7
      • Chaleur Regional Hospital
    • Campbellton, New Brunswick, Canada, E3N 3H3
      • Campbellton Regional Hospital
    • Edmundston, New Brunswick, Canada, E3V 4E4
      • Edmundston Regional Hospital
    • Moncton, New Brunswick, Canada, E1C 2Z3
      • Dr. George-L.-Dumont University Hospital Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients initiated on long-acting injectable anipsychotics from the regional hospitals under the direction of the Vitalité health network.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Paliperidone Palmitate; Patients who have received a minimum of 3 months of treatment with an injection of paliperidone palmitate.	Drug: Paliperidone Palmitate; Monthly injections; Other Names: Invega Sustenna; Drug: Antipsychotic; Any oral antipsychotic prescribed to be taken on a regular basis prior to the initiation of a long-acting injectable antipsychotic.; Other Names: Oral antipsychotics
Risperidone Long-acting injection.; Patients who have received a minimum of 3 months of treatment with Risperidone long-acting injection.	Drug: Antipsychotic; Any oral antipsychotic prescribed to be taken on a regular basis prior to the initiation of a long-acting injectable antipsychotic.; Other Names: Oral antipsychotics; Drug: Risperidal Consta; Bi-weekly injection; Other Names: Risperidone long-acting injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Psychiatric Relapse	Hospitalizations will be used as a proxy for relapse and the primary endpoint will be the number of hospital admissions following the discharge date of the index admission for up to 3 years compared to an equivalent timeframe prior to the beginning of the index admission (and including the 1st day of the index admission). Patients will be considered eligible for the primary objective after 3 months of continued long-acting injection treatment.	up to 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital Resource utilization for psychiatric reasons	Number of ER visits for psychiatric reasons, number of days admitted in hospital for psychiatric reasons.	up to 3 years
Time to relapse	time following discharge of index admission until the subsequent admission for psychiatric reasons (in days); time following discharge of index admission until the subsequent ER visit for psychiatric reasons (in days).	up to 3 years

Collaborators and Investigators

• Sponsor: Réseau de Santé Vitalité Health Network
• Collaborators: Janssen Inc.

Study record dates

Study Major Dates

• Study Start (Anticipated): January 2, 2018
• Primary Completion (Anticipated): September 1, 2018
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: December 28, 2017
• First Submitted That Met QC Criteria: December 28, 2017
• First Posted (Actual): January 4, 2018

Study Record Updates

• Last Update Posted (Actual): January 4, 2018
• Last Update Submitted That Met QC Criteria: December 28, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: Paliperidone palmitate; Risperidone long-acting injection; mirror-image
• Additional Relevant MeSH Terms: Schizophrenia; Psychotic Disorders; Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Dopamine Agents; Serotonin 5-HT2 Receptor Antagonists; Serotonin Antagonists; Dopamine D2 Receptor Antagonists; Dopamine Antagonists; Paliperidone Palmitate; Risperidone; Antipsychotic Agents
• Other Study ID Numbers: PHAR-1701

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No