A 52 Week Open-label Extension Trial Following the Double-blind Efficacy and Safety Study R076477-SCH-305.

• Status: Completed
• Trial end date: 2006-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

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

Details

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

Criteria

Inclusion Criteria:

• Study R076477-SCH-707 enrolled patients who met the DSM-IV criteria of schizophrenia for at least 1 year

• Eligible patients were experiencing active symptoms at the time of enrollment and had a PANSS total score between 70 and 120

• The open-label extension study population comprised patients who had completed the 6-week double-blind phase of the study or who had discontinued due to lack of efficacy after at least 21 days of treatment.

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