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A Twelve-Month, Prospective, Randomized, Active-Controlled, Open-Label, Flexible-Dose Study of Paliperidone Palmitate Compared With Oral Antipsychotic Treatment in Adults With Schizophrenia Who Have Been Recently Discharged From an Inpatient Psychiatric Hospital
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.
The primary objective of this study will be to compare paliperidone palmitate treatment with the randomly assigned oral antipsychotic treatment in delaying time to treatment failure over 12 months in subjects diagnosed with schizophrenia who were recently discharged from an inpatient psychiatric hospital. Patients will receive either paliperidone palmitate 78, 117, 156, or 234 mg monthly by injection for twelve months OR oral aripiprazole, haloperidol, olanzapine, paliperidone, perphenazine, quetiapine, and risperidone at doses selected by the study doctor.
Age
18 - 65 years
Sex
ALL
Healthy Volunteers
No
Start Date
August 1, 2010
Primary Completion Date
September 1, 2012
Completion Date
September 1, 2012
Last Updated
July 8, 2013
paliperidone palmitate
DRUG
risperidone
DRUG
olanzapine
DRUG
aripiprazole
DRUG
haloperidole
DRUG
quetiapine
DRUG
perphenazine
DRUG
paliperidone
DRUG
Lead Sponsor
Ortho-McNeil Janssen Scientific Affairs, LLC
NCT07455929
NCT06740383
Data Source & Attribution
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