Schizophrenia Spectrum and Other Psychotic Disorders
Conditions
Keywords
Paliperidone palmitate, Risperidone long-acting injection, mirror-image
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.
Interventions
DRUGPaliperidone Palmitate
Monthly injections
Bi-weekly injection
DRUGAntipsychotic
Any oral antipsychotic prescribed to be taken on a regular basis prior to the initiation of a long-acting injectable antipsychotic.
Sponsors
Janssen Inc.
Réseau de Santé Vitalité Health Network
Study design
Observational model
OTHER
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
Canada
Outcome results
None listed