An observational study in Schizophrenia Spectrum and Other Psychotic Disorders, sponsored by Réseau de Santé Vitalité Health Network. Status unknown at 4 sites in Canada. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-01-04.
Sponsored by Réseau de Santé Vitalité Health Network · Observational
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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.
84 studies on the registry are indexed under Schizophrenia Spectrum and Other Psychotic Disorders; 14 are open to participants now.
This study's planned enrollment of 328 is above the median of 175 across 16 observational studies indexed under Schizophrenia Spectrum and Other Psychotic Disorders.
Browse Schizophrenia Spectrum and Other Psychotic Disorders studies →Réseau de Santé Vitalité Health Network is the lead sponsor of 7 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients initiated on long-acting injectable anipsychotics from the regional hospitals under the direction of the Vitalité health network.
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Exclusion Criteria:
Patients who have received a minimum of 3 months of treatment with an injection of paliperidone palmitate.
Drug: Paliperidone Palmitate · Drug: Antipsychotic
Patients who have received a minimum of 3 months of treatment with Risperidone long-acting injection.
Drug: Risperidal Consta · Drug: Antipsychotic
Monthly injections
Also known as: Invega Sustenna
Bi-weekly injection
Also known as: Risperidone long-acting injection
Any oral antipsychotic prescribed to be taken on a regular basis prior to the initiation of a long-acting injectable antipsychotic.
Also known as: Oral antipsychotics
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
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
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Jan 2018; primary completion for Sep 2018, 8 months later.
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This study is status unknown, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.
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Schizophrenia Spectrum and Other Psychotic Disorders →
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