A Study of the Long-term Safety and Tolerability and the Long-term Effectiveness of Extended-release Oral Paliperidone in Patients Diagnosed With Schizophrenia

• Status: Completed
• Trial end date: 2005-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the long-term safety and tolerability and the maintenance of effectiveness of a slow, extended-release oral formulation of paliperidone administered once daily to patients diagnosed 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:

• As for the double-blind study, a diagnosis of schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM IV)

• experiencing an acute episode of schizophrenia at time of screening for the double-blind study, with a total PANSS score of 70 to 120

• completed the double-blind study or discontinued after at least 21 days of double-blind treatment because of lack of efficacy

• for female patients of childbearing potential, agreement to continue to use an acceptable form of contraception throughout the open-label extension, with a negative urine pregnancy test at open-label baseline.

Exclusion Criteria:

• As for the double-blind study, a DSM-IV axis I diagnosis other than schizophrenia

• a DSM-IV diagnosis of substance dependence within 6 months prior to screening for the double-blind study

• considered by the investigator to be at significant risk for suicidal or violent behavior during the open-label study

• received an injection of a depot antipsychotic since entry into the double-blind study

• a woman who has become pregnant.