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

Study Overview
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Brief Summary
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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.

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

Conditions
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Schizophrenia Spectrum and Other Psychotic Disorders

Intervention / Treatment
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* Drug: Paliperidone Palmitate
* Drug: Risperidal Consta
* Drug: Antipsychotic


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Paliperidone palmitate, Risperidone long-acting injection, mirror-image