An Exploratory Study on the Safety and Effectiveness of Paliperidone in Patients With Schizophrenia

• Status: Completed
• Trial end date: 2005-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the safety, effectiveness, and plasma concentration of paliperidone (an antipsychotic medication) given once daily in the treatment of patients with schizophrenia

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Pharmaceutical K.K.
• Treatments: Paliperidone Palmitate

Criteria

Inclusion Criteria:

• Patients diagnosed with schizophrenia according to the diagnostic criteria of DSM-IV

• taking not more than one oral antipsychotic medication within 28 days of study entry

• a score below 120 at pre-treatment on the Positive and Negative Syndrome Scale Score (PANSS), a scale for the measurement of symptoms of schizophrenia

Exclusion Criteria:

• Diagnosis of psychiatric disease other than schizophrenia according to the diagnostic criteria of DSM-IV

• history of Parkinson's disease, seizure disorder, cerebrovascular accident, diabetes mellitus, clinically significant gastrointestinal disorders, or severe impairment of the liver or kidneys

• drug allergy or hypersensitivity to antipsychotics