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

Sponsor

Réseau de Santé Vitalité Health Network (Other)

Overall Status

Unknown status

CT.gov ID

NCT03390712

Collaborator

Janssen Inc. (Industry)

328

Enrollment

Locations

10.9

Anticipated Duration (Months)

Patients Per Site

7.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia Spectrum and Other Psychotic Disorders	Drug: Paliperidone Palmitate Drug: Risperidal Consta Drug: Antipsychotic

Study Design

Study Type:

Observational

Anticipated Enrollment :

328 participants

Observational Model:

Other

Time Perspective:

Retrospective

Official Title:

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

Anticipated Study Start Date :

Jan 2, 2018

Anticipated Primary Completion Date :

Sep 1, 2018

Anticipated Study Completion Date :

Dec 1, 2018

Arms and Interventions

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

Arm

Intervention/Treatment

Paliperidone Palmitate

Patients who have received a minimum of 3 months of treatment with an injection of paliperidone palmitate.

Drug: Paliperidone Palmitate

Monthly injections

Other Names:

Invega Sustenna

Drug: Antipsychotic

Any oral antipsychotic prescribed to be taken on a regular basis prior to the initiation of a long-acting injectable antipsychotic.

Other Names:

Oral antipsychotics

Risperidone Long-acting injection.

Patients who have received a minimum of 3 months of treatment with Risperidone long-acting injection.

Drug: Risperidal Consta

Bi-weekly injection

Other Names:

Risperidone long-acting injection

Drug: Antipsychotic

Any oral antipsychotic prescribed to be taken on a regular basis prior to the initiation of a long-acting injectable antipsychotic.

Other Names:

Oral antipsychotics

Outcome Measures

Primary Outcome Measures

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

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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chaleur Regional Hospital	Bathurst	New Brunswick	Canada	E2A 4L7
2	Campbellton Regional Hospital	Campbellton	New Brunswick	Canada	E3N 3H3
3	Edmundston Regional Hospital	Edmundston	New Brunswick	Canada	E3V 4E4
4	Dr. George-L.-Dumont University Hospital Center	Moncton	New Brunswick	Canada	E1C 2Z3