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

R

Réseau de Santé Vitalité Health Network

Status

Unknown

Conditions

Schizophrenia Spectrum and Other Psychotic Disorders

Treatments

Drug: Paliperidone Palmitate
Drug: Risperidal Consta
Drug: Antipsychotic

Study type

Observational

Funder types

Other
Industry

Identifiers

NCT03390712
PHAR-1701

Details and patient eligibility

About

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.

Enrollment

328 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.

Trial design

328 participants in 2 patient groups

Paliperidone Palmitate
Description:
Patients who have received a minimum of 3 months of treatment with an injection of paliperidone palmitate.
Treatment:
Drug: Antipsychotic
Drug: Paliperidone Palmitate
Risperidone Long-acting injection.
Description:
Patients who have received a minimum of 3 months of treatment with Risperidone long-acting injection.
Treatment:
Drug: Antipsychotic
Drug: Risperidal Consta

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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