Efficacy and Safety of Paliperidone ER in First Episode Psychosis

• Status: Completed
• Trial end date: 2013-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of the study is to investigate the efficacy and safety of Paliperidone ER in patients with first episode psychosis.

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

Details

• Lead Sponsor: Chonbuk National University Hospital
• Collaborator: Janssen Korea, Ltd., Korea
• Treatments: Paliperidone Palmitate

Criteria

Inclusion Criteria:

• Aged 18-59 years and meet DSM-IV diagnostic criteria for first episode of schizophrenia, schizophreniform disorder, schizoaffective disorder or psychotic disorder NOS as assessed by using the Structured Clinical Interview for DSM-IV, research version.

Exclusion Criteria:

• Meeting DSM-IV criteria for another axis I diagnosis, including substance abuse or dependence

• Needing another nonantipsychotic psychotropic medication at enrollment

• Having a serious or unstable medical illness.

• Pregnant or lactating women or women without adequate contraception will be also excluded.