A Phase 3 interventional study of Paliperidone in Schizophrenia, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.. Completed. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2011-06-08.
Sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. · Phase 3, Interventional, and Treatment
Open-Label Extension to the double-blind effectiveness and safety study R076477-SCH-305 to evaluate long-term safety and tolerability in patients with schizophrenia.
The primary objective of the open-label extension trial was the long-term assessment of safety and tolerability of flexibly-dosed ER OROS paliperidone (3 to 15 mg/day) in patients with a diagnosis of schizophrenia. Other measures assessed in the extension study included: change in the total Positive and Negative Syndrome Scale (PANSS) score; change in PANSS subscale (positive and negative) scores; overall functioning, as measured by the Clinical Global Impression Scale-Severity (CGI-S); personal and social functioning, as measured by the Personal and Social Performance Scale (PSP); and quality of life parameters, as measured by the Schizophrenia Quality of Life Scale, Revision 4 (SQLS-R4). Paliperidone ER OROS® tablet formulation (3 to 15 mg/day) to be taken orally for 52 weeks
3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.
This study's enrollment of 407 is above the median of 70 across 2,872 interventional studies indexed under Schizophrenia.
Browse Schizophrenia studies →Johnson & Johnson Pharmaceutical Research & Development, L.L.C. is the lead sponsor of 458 studies on the registry; none are open to participants now.
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Flexibly-dosed ER OROS paliperidone 3 mg to 15 mg/day was safe and well tolerated in patients with schizophrenia. The safety profile was generally consistent with that observed in subjects after short-term use in the double-blind studies
Findings showed stability of symptoms or further improvements in the severity of symptoms associated with schizophrenia (PANSS), personal and social functioning (PSP), global severity of illness (CGI-S), and patient-rated symptoms and well-being (SQLS)
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This study is completed, as verified in Mar 2010. You cannot join it, but the record below documents what was studied.
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Johnson & Johnson Pharmaceutical Research & Development, L.L.C.