A 52-week, Open-label Extension Study Following a 6-week, Double-blind, Placebo- and Active- Controlled Study (R076477-SCH-303) to Evaluate the Safety and Tolerability of Paliperidone ER in Subjects With Schizophrenia

Johnson & Johnson (J&J)

Status and phase: Completed; Phase 3

Conditions: Schizophrenia

Treatments: Drug: Extended Release OROS® Paliperidone

Study type: Interventional

Funder types: Industry

Identifiers

NCT00650793

CR003376

Details and patient eligibility

About

The purpose of the study was an Open Label Extension to a completed study that evaluated the efficacy and safety of 3 fixed dosages of Extended Release OROS® Paliperidone

Full description

This 52-week, open-label extension study followed a 6-week, double-blind, placebo- and active-controlled study (R076477-SCH-303) and was conducted at 52 sites in 11 countries. The primary objective of the open-label extension was the long-term assessment of safety and tolerability of flexibly-dosed ER OROS® paliperidone. The secondary objective was the assessment of long-term efficacy expressed as a function of change in the total Positive and Negative Syndrome Scale (PANSS) score, effect on positive and negative symptoms of schizophrenia by means of change in PANSS factor scores, and personal and social functioning, overall functioning, and quality of life parameters as measured by Personal and Social Performance Scale (PSP), Clinical Global Impression Scale - Severity (CGI-S), and Schizophrenia Quality of Life Scale (SQLS), respectively. Subjects in the open-label phase received flexibly dosed ER OROS® paliperidone (3 mg to 12 mg/day) for 52 weeks

Enrollment: 473 patients

Sex: All

Ages: 18+ 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

• Not eligible to enter the open-label phase if believed to be at significant risk for suicidal or violent behavior during the open-label extension trial, were pregnant, or had received an injection of a depot antipsychotic since entry into the preceding double-blind phase

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)