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

Schizophrenia Spectrum and Other Psychotic Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03390712
• Other study ID #: PHAR-1701
• Status: Enrolling by invitation
• Phase: N/A
• First received: December 28, 2017
• Last updated: December 28, 2017
• Start date: January 2, 2018
• Est. completion date: December 2018

Study information

• Verified date: December 2017
• Source: Réseau de Santé Vitalité Health Network
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 328
• Est. completion date: December 2018
• Est. primary completion date: September 2018
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Mental Disorders
• Psychotic Disorders
• Schizophrenia
• Schizophrenia Spectrum and Other Psychotic Disorders

Intervention

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

Locations

Country	Name	City	State
Canada	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

Sponsors (2)

Lead Sponsor	Collaborator
Réseau de Santé Vitalité Health Network	Janssen Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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