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

Johnson & Johnson (J&J)

Status and phase

Completed

Phase 3

Conditions

Schizophrenia

Treatments

Drug: Paliperidone ER OROS®

Study type

Interventional

Funder types

Industry

Identifiers

NCT00752427

CR004423

Details and patient eligibility

About

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

Full description

The primary objective of the open-label extension phase was the long-term assessment of safety and tolerability of Extended Release (ER) OROS paliperidone (3 mg to 12 mg/day) in subjects (>65 years of age) with schizophrenia, and the secondary objective was the assessment of long-term efficacy.

Paliperidone ER OROS® tablet formulation (3 to 12 mg/day) to be taken orally

Enrollment

86 patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

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