Mirror-image Study of Paliperidone Palmitate and Risperidone Long-acting Injection
- Conditions
- Schizophrenia Spectrum and Other Psychotic Disorders
- Interventions
- Registration Number
- NCT03390712
- Lead Sponsor
- Réseau de Santé Vitalité Health Network
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 328
• 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.
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Risperidone Long-acting injection. Risperidal Consta Patients who have received a minimum of 3 months of treatment with Risperidone long-acting injection. Paliperidone Palmitate Paliperidone Palmitate Patients who have received a minimum of 3 months of treatment with an injection of paliperidone palmitate. Paliperidone Palmitate Antipsychotic Patients who have received a minimum of 3 months of treatment with an injection of paliperidone palmitate. Risperidone Long-acting injection. Antipsychotic Patients who have received a minimum of 3 months of treatment with Risperidone long-acting injection.
- Primary Outcome Measures
Name Time Method Psychiatric Relapse up to 3 years 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.
- Secondary Outcome Measures
Name Time Method Hospital Resource utilization for psychiatric reasons up to 3 years Number of ER visits for psychiatric reasons, number of days admitted in hospital for psychiatric reasons.
Time to relapse up to 3 years 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).
Trial Locations
- Locations (4)
Dr. George-L.-Dumont University Hospital Center
🇨🇦Moncton, New Brunswick, Canada
Edmundston Regional Hospital
🇨🇦Edmundston, New Brunswick, Canada
Chaleur Regional Hospital
🇨🇦Bathurst, New Brunswick, Canada
Campbellton Regional Hospital
🇨🇦Campbellton, New Brunswick, Canada