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PRIDE: Paliperidone Palmitate vs Oral Antipsychotics in Incarcerated Schizophrenia Patients
NCT01157351Phase 4
Key facts
- Status
- Completed
- Start
- May 2010
- Primary completion
- Dec 2013
- Countries
- 2
- Sponsor
- Janssen Scientific Affairs
- Modality
- Metabolically Activated Prodrugs
- Conditions
- schizophrenia
01
Overview
Phase 4, randomised, open-label trial of paliperidone palmitate in schizophrenia (8 arms), sponsored by Janssen Scientific Affairs. Primary endpoints: Time to First Treatment Failure at 15 months and Percentage of Participants in Each Event Category of First Treatment Failure at 15 months. Started May 2010; status: completed.
02
Design
8 arms- Study design
- RandomizedOpen-label
Paliperidone Palmitate
Monthly injection
Oral Aripiprazole
Daily oral
Oral Haloperidol
Daily oral
Oral Olanzapine
Daily oral
Oral Paliperidone
Daily oral
Oral Perphenazine
Daily oral
2 more in the full profile.
03
Who it enrols
Adults with schizophrenia and a history of incarceration (2+ custody placements in 24 months, last release <90 days). Must be eligible for oral antipsychotics but benefit from change. Excludes active IV drug use or opiate dependence.
04
Endpoints
Primary
Time to First Treatment Failure
Percentage of Participants in Each Event Category of First Treatment Failure
Secondary
Time to First Psychiatric Hospitalization or Arrest/Incarceration
Change From Baseline in Personal and Social Performance (PSP) Total Score
Time to First Psychiatric Hospitalization
Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score
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