24-Week Open Label Extension to a Randomized, 6-Week Double Blind, Placebo Controlled Study, to Evaluate the Safety and Tolerability of Flexible Doses of Extended Release OROS® Paliperidone in the Treatment of Geriatric Subjects With Schizophrenia

• Status: Completed
• Trial end date: 2005-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this open-label study was to evaluate the safety and tolerability of flexible doses of Extended Release OROS® Paliperidone in the treatment of geriatric subjects with schizophrenia after completion of the initial double blind study

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Treatments: Paliperidone Palmitate

Criteria

Inclusion Criteria:

• Subjects who had completed the double-blind phase or discontinued due to lack of efficacy after at least 21 days of treatment, who signed the informed consent for the open-label phase, and who the investigator agreed that open-label treatment was in the best interest of the subject were eligible to participate in the open label phase

Exclusion Criteria:

• Significant and/or unstable systemic illnesses

• Allergy or hypersensitivity to risperidone or paliperidone

• Significant risk of suicidal or violent behavior

• Biochemistry, hematology, or urinalysis results that are not within the laboratory's reference range, and that are deemed by the investigator to be clinically significant