Trial Evaluating the Efficacy and Safety of 2 Fixed Doses of Paliperidone Extended-Release (ER) Tablets in the Treatment of Adult Patients With Schizophrenia

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

Summary

The purpose of this trial is to determine if paliperidone ER is an effective treatment for adults 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: DSM-IV diagnosis of schizophrenia for at least 1 year

• experiencing an acute episode, with a total PANSS score at screening between 70 and 120

• agree to voluntary hospitalization for a minimum of 14 days. Open-label phase: must have completed the 6 weeks of double-blind treatment or completed at least 21 days of treatment and discontinued due to lack of efficacy.

Exclusion Criteria:

• DSM-IV axis I diagnosis other than schizophrenia

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

• history of neuroleptic malignant syndrome (NMS)

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

• previous history of lack of response to risperidone when acutely psychotic

• significant risk of suicidal or violent behavior.