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Twelve Month Study Comparing Paliperidone Palmitate and Select Oral Antipsychotics in Adults With Schizophrenia Who Have Been Recently Discharged From an Inpatient Psychiatric Hospital

NCT01193166 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2013-07-08

No results posted yet for this study

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 12 months, in patients diagnosed with schizophrenia who were recently released from an inpatient psychiatric hospital.

Conditions

Interventions

DRUG

paliperidone palmitate

78, 117, 156, or 234 mg monthly injection for 12 months

DRUG

risperidone

flexible dosing as prescribed by the study doctor for 12 months

DRUG

olanzapine

flexible dosing as prescribed by the study doctor for 12 months

DRUG

aripiprazole

flexible dosing as prescribed by the study doctor for 12 months

DRUG

haloperidole

flexible dosing as prescribed by the study doctor for 12 months

DRUG

quetiapine

flexible dosing as prescribed by the study doctor for 12 months

DRUG

perphenazine

flexible dosing as prescribed by the study doctor for 12 months

DRUG

paliperidone

flexible dosing as prescribed by the study doctor for 12 months

Sponsors & Collaborators

  • Ortho-McNeil Janssen Scientific Affairs, LLC

    lead INDUSTRY

Principal Investigators

  • Ortho-McNeil Janssen Scientific Affairs, LLC Clinical Trial · Ortho-McNeil 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
2010-08-31
Primary Completion
2012-09-30
Completion
2012-09-30

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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 NCT01193166 on ClinicalTrials.gov