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15 Month Study for Adults Who Have Been Diagnosed With Schizophrenia and Incarcerated

NCT01157351 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 450

Last updated 2015-04-24

Study results available
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Summary

The study will assess the use of paliperidone palmitate compared with oral antipsychotic treatment in delaying time to a protocol-defined treatment failure over 15 months, in patients diagnosed with schizophrenia who have been incarcerated.

Conditions

Interventions

DRUG

paliperidone

flexible dosing as prescribed by the study doctor for 15 months

DRUG

risperidone

flexible dosing as prescribed by the study doctor for 15 months

DRUG

haloperidole

flexible dosing as prescribed by the study doctor for 15 months

DRUG

perphenazine

flexible dosing as prescribed by the study doctor for 15 months

DRUG

aripiprazole

flexible dosing as prescribed by the study doctor for 15 months

DRUG

quetiapine

flexible dosing as prescribed by the study doctor for 15 months

DRUG

paliperidone palmitate

78, 117, 156, or 234 mg monthly injection for 15 months

DRUG

olanzapine

flexible dosing as prescribed by the study doctor for 15 months

Sponsors & Collaborators

  • Janssen Scientific Affairs, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Scientific Affairs, LLC Clinical Trial · Janssen Scientific Affairs, LLC

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • United States
  • Puerto Rico

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01157351 on ClinicalTrials.gov