Overview

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

Status:
Completed
Trial end date:
2008-02-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to measure the effectiveness and assess the safety of two dosages 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