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The primary objective of the double-blind phase of this study is to evaluate the efficacy and safety of 3 fixed dosages of paliperidone ER (3, 9, and 15 mg/day) compared with placebo in adult patients with schizophrenia
Paliperidone is being developed as a new therapeutic agent for the treatment of schizophrenia. The extended-release (ER) formulation of paliperidone was developed to deliver paliperidone at a relatively constant rate over a 24-hour period to improve the tolerability profile and decrease the potential for orthostatic hypotension. This study is designed to evaluate the efficacy and safety and tolerability of 3 dosages of paliperidone ER compared with placebo in adult patients with schizophrenia. This is a multicenter, double-blind, randomized, placebo- and active-controlled, parallel-group, dose-response study. Patients will be randomized into 1 of 5 treatment groups to receive oral dosages of paliperidone ER 3, 9, or 15 mg, olanzapine 10 mg, or placebo once daily for a 6-week period. The study includes a screening period of up to 5 days, followed by a 6-week double-blind treatment phase. Following the double-blind treatment phase, eligible patients (those who have completed the 6-week double-blind phase or who discontinue due to lack of efficacy after a minimum of 21 days) may enter the 52-week open-label extension with paliperidone ER monotherapy. While patients are hospitalized, efficacy will be assessed twice during the first week and at the end of the second week, and after patients are discharged from the hospital, they will return to have efficacy and safety assessments performed on a weekly basis through the end of the 6-week double-blind phase. Efficacy will be evaluated throughout the 6-week double-blind phase by completion of the Positive and Negative Syndrome Scale (PANSS), Clinical Global Impression Scale - Severity (CGI-S), Personal and Social Performance Scale (PSP), and Schizophrenia Quality of Life Scale, Revision 4 (SQLS-R4). The primary efficacy response will be measured by the change from baseline score to end of double-blind phase for PANSS total score. Safety will be monitored throughout the study and includes assessments of the incidence of adverse events; measurement of extrapyramidal symptoms using 3 rating scales (Abnormal Involuntary Movement Scale [AIMS], Barnes Akathisia Rating Scale [BARS], Simpson-Angus Rating Scale [SAS]); measurement of vital signs (laying down and standing blood pressure, pulse, temperature); electrocardiograms; and clinical laboratory tests. Double-blind phase: 3, 9, 15 mg of paliperidone ER, 10 mg of olanzapine or placebo taken orally once a day for 6 weeks.
Open-label phase: start on paliperidone ER 9 mg orally once a day; maintained on a flexible oral dosage of paliperidone ER (3, 6, 9, 12, or 15 mg/day) for 52 weeks.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Published on BioPortfolio: 2014-08-27T03:54:23-0400
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A benzisoxazole derivative and active metabolite of RISPERIDONE that functions as a DOPAMINE D2 RECEPTOR ANTAGONIST and SEROTONIN 5-HT2 RECEPTOR ANTAGONIST. It is an ANTIPSYCHOTIC AGENT used in the treatment of SCHIZOPHRENIA.
A chronic form of schizophrenia characterized primarily by the presence of persecutory or grandiose delusions, often associated with hallucination.
A type of schizophrenia characterized by abnormality of motor behavior which may involve particular forms of stupor, rigidity, excitement or inappropriate posture.
An obsolete concept, historically used for childhood mental disorders thought to be a form of schizophrenia.
A type of schizophrenia characterized by frequent incoherence; marked loosening of associations, or grossly disorganized behavior and flat or grossly inappropriate affect that does not meet the criteria for the catatonic type; associated features include extreme social withdrawal, grimacing, mannerisms, mirror gazing, inappropriate giggling, and other odd behavior. (Dorland, 27th ed)
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