Safety Study With Paliperidone ER Extended-Release (ER) Tablets in Geriatric Patients With Schizophrenia

• Status: Completed
• Trial end date: 2005-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of the study is to evaluate the safety and tolerability of flexible dosages of paliperidone ER as compared with placebo in patients with schizophrenia who are 65 years of age or older. The primary objective of the open-label extension is the long-term assessment of safety and tolerability of paliperidone ER in 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:

• Double-Blind Phase: 65 years of age or older

• DSM-IV diagnosis of schizophrenia for at least 1 year

• total PANSS score at screening and baseline between 70 and 120, inclusive

• agrees to hospitalization for a minimum of 14 days and for the duration of the study, if clinically indicated

• Open-label treatment phase: completed 6 weeks of the double-blind treatment phase or finished at least 21 days of treatment and discontinued because of lack of efficacy.

Exclusion Criteria:

• DSM-IV Axis I diagnosis other than schizophrenia

• DSM-IV diagnosis of substance dependence within the 6 months before screening (nicotine and caffeine dependence are not exclusionary)

• history of tardive dyskinesia or neuroleptic malignant syndrome (NMS)

• history of any severe preexisting severe gastrointestinal narrowing (pathologic or iatrogenic)

• previous history of a lack of response (2 adequate trials) to any antipsychotic