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

Réseau de Santé Vitalité Health Network328 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

328

Conditions

Schizophrenia Spectrum and Other Psychotic Disorders

Interventions

Paliperidone PalmitateDRUG

Monthly injections

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (4)

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

Outcomes

Primary Outcomes

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.

Time frame: up to 3 years

Secondary Outcomes

Hospital Resource utilization for psychiatric reasons

Number of ER visits for psychiatric reasons, number of days admitted in hospital for psychiatric reasons.

Time frame: 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).

Time frame: up to 3 years