A Study to Evaluate Symptomatic Remission in Schizophrenia With Long Acting Risperidone Microspheres

• Status: Completed
• Trial end date: 2007-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate symptomatic remission rate in patients with schizophrenia using long acting risperidone microspheres

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

Details

• Lead Sponsor: Janssen Korea, Ltd., Korea
• Treatments: Risperidone

Criteria

Inclusion Criteria:

• Subjects with schizophrenia or schizoaffective disorder - Subjects who have experienced relapse or re-admission previously - Subject and/or his/her relative, guardian or legal representative who has signed the informed consent form

Exclusion Criteria:

• First antipsychotic treatment ever - On clozapine during the last 3 months - Serious unstable medical condition, including recent and present clinically relevant laboratory abnormalities - Subjects that are previously on concomitant use of Risperdal Consta within 60 days prior to entry - Previous sensitivity history to risperidone - History or current symptoms of tardive dyskinesia - History of neuroleptic malignant syndrome - Pregnant or breast-feeding female - Female patient of childbearing age without adequate contraception (adequate contraception includes: abstinence, oral contraceptive, intrauterine devices, barrier method (diaphragm or condom) plus spermicide - Norplant TM or Depo-Provera TM. A female patient of childbearing potential must have an adequate contraception and a negative urine pregnancy test at every visit)