Evaluation of Effectiveness and Safety of Paliperidone ER (Extended-release) Compared With Quetiapine in Patients With Schizophrenia

• Status: Completed
• Trial end date: 2007-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy (effectiveness of drug) and safety of the antipsychotic paliperidone ER compared to another antipsychotic, quetiapine, and to placebo in patients who are acutely ill with symptoms of schizophrenia.

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

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Collaborator: Janssen, LP
• Treatments: Paliperidone Palmitate; Quetiapine Fumarate

Criteria

Inclusion Criteria:

• Diagnostic and Statistical Manual - Fourth Edition (DSM-IV) diagnosis of schizophrenia (paranoid, disorganized or undifferentiated type)

• score of >=4 on at least two of a subset of selected PANSS items and a total score on these five items of >=17

• score of >=5 on the CGI-S (clinical global impression - severity)

• body weight of at least 60kg and willing to be hospitalized for 9 days initially

Exclusion Criteria:

• A primary active mental illness diagnosis other than schizophrenia

• subjects whose psychotic symptoms can be explained by substance intake or medical illness

• pregnancy, breast-feeding, or planning to become pregnant

• a history of treatment resistance (defined by failure to respond to 2 adequate trials of different antipsychotic medications or clozapine given at adequate dose for sufficient time)

• unstable or significant medical illness that would increase risk of taking study medication or would confuse the interpretation of the study