A Study of Effectiveness and Safety of Paliperidone Extended-release (ER) Tablets in the Prevention of Recurrence in Adult Patients With Schizophrenia.

• Status: Completed
• Trial end date: 2005-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the efficacy (effectiveness) and safety of paliperidone ER compared with placebo in the prevention of recurrence of symptoms of 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:

• DSM-IV diagnosis of schizophrenia at least 1 year before screening

• experiencing an acute schizophrenic episode with a total PANSS score between 70 and 120

• agree to be hospitalized for a minimum of 14 days at the start of the study

• capable of administering study medication themselves or have assistance with study medication administration consistently available throughout the study

• resided at the same address continuously for at least 30 days prior to screening

• able and willing to fill out self administered questionnaires

• washout of antiparkinsonian medications, beta-blockers

• antiepileptics, lithium 3 days prior to the start of the run-in phase

Exclusion Criteria:

• DSM-IV Axis I diagnosis other than schizophrenia

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

• preexisting severe gastrointestinal narrowing (pathologic or iatrogenic)

• injection of a depot antipsychotic within 120 days before screening, or use of paliperidone palmitate within 10 months before screening

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

• history of neuroleptic malignant syndrome

• significant risk of suicidal or violent behavior