Evaluation of Effectiveness and Safety of Flexible-dose Paliperidone Extended Release in Patients With Schizoaffective Disorder.

• Status: Completed
• Trial end date: 2008-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to measure the effectiveness and assess the safety of different dosages (from 3 mg/day to 12 mg/day) of the antipsychotic paliperidone extended-release (ER) in patients who are experiencing an acute episode of schizoaffective disorder.

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

Details

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

Criteria

Inclusion Criteria:

• Diagnostic and Statistical Manual - Fourth Edition (DSM-IV) diagnosis of schizoaffective disorder

• A total Positive and Negative Symptoms of Schizophrenia (PANSS) score of >= 60

• A score of >= 16 on Young Mania Rating Scale (YMRS) or a score of >= 16 on the Hamilton Depression Rating Scale (HAM-D 21)

Exclusion Criteria:

• A primary active mental illness diagnosis other than schizoaffective disorder

• Patients with first episode psychosis

• Active substance dependence within previous 6 months

• Treatment with clozapine within 6 months of randomization

• A history of treatment resistance, defined by failure to respond to 2 adequate trials of antipsychotic medication

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