A Study of Paliperidone Palmitate in Patients With Schizophrenia Previously Unsuccessfully Treated by Oral Antipsychotics

• Status: Completed
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the effectiveness, safety and tolerability of flexibly dosed paliperidone palmitate in patients with schizophrenia previously unsuccessfully treated by oral antipsychotics and with acute symptom of schizophrenia.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Xian-Janssen Pharmaceutical Ltd.
• Treatments: Antipsychotic Agents; Paliperidone Palmitate

Criteria

Inclusion Criteria:

• Previous diagnosis of schizophrenia

• Experiencing an acute episode, with a Positive and Negative Syndrome Scale (PANSS) total score between 70 and 120, inclusive

• Patients currently treated with antipsychotic are allowed to be recruited

• Be medically stable on the basis of clinical laboratory tests performed at screening

Exclusion Criteria:

• A primary diagnosis other than schizophrenia

• History of risperidone or paliperidone resistance as defined by failure to respond to 2 adequate treatment periods

• Clozapine use for treatment refractory schizophrenia

• Relevant history or current presence of any significant or unstable condition, disease or illness that could limit the participation in the study according to the investigator

• Woman who is pregnant, breast-feeding, or is planning to become pregnant within 6 months