Safety, Efficacy and Tolerability Study of Paliperidone Extended-Release (ER) in Participants With Schizophrenia

• Status: Completed
• Trial end date: 2009-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to explore the efficacy of flexibly dosed paliperidone extended-release (ER) in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) who were previously unsuccessfully treated with other oral antipsychotics.

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

Details

• Lead Sponsor: Janssen Pharmaceutica
• Treatments: Paliperidone Palmitate

Criteria

Inclusion Criteria:

• Participant diagnosed with schizophrenia

• Participant's previous treatment of schizophrenia is considered unsuccessful

• Participant is healthy on the basis of a physical examination and vital signs

• Women must be postmenopausal, surgically sterile, abstinent, or, if sexually active, agree to practice an effective method of birth control before entry and throughout the study

• Be willing and able to fill out self-administered questionnaires

Exclusion Criteria:

• Have used clozapine or Risperdal CONSTA during the last month, or have received any other conventional drug used to treat psychosis during the last 3 months

• Judged to be at high risk for adverse events, violence or self-harm

• Inability to swallow the study medication whole with the aid of water

• Pregnant or breast-feeding female

• History or current symptoms of tardive dyskinesia (involuntary movements of the facial muscles and tongue)