A Follow-Up Study of Schizophrenic Participants Following Treatment Discontinuation After Remission From a First Psychotic Episode

• Status: Completed
• Trial end date: 2010-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the outcome of medication discontinuation, the safety and effectiveness of re-initiating risperidone long acting injection (RLAI) in case of relapse (the return of a medical problem) of schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) during the study observation period of 36 months.

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

Details

• Lead Sponsor: Janssen Cilag N.V./S.A.
• Treatments: Risperidone

Criteria

Inclusion Criteria: - Participants who completed 24 months RIS-PSY-301 study - Surgically sterile female participants or practicing an effective method of birth control before entry and throughout the study; and must have shown a negative urine serum pregnancy test at baseline before study entry - Participants who have signed informed consent document Exclusion Criteria: - Participants requiring treatment with mood stabilizers or antidepressants at study entry - Participants with evidence of alcohol or drug abuse or dependence (except for nicotine and caffeine dependence) according to Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria diagnosed in the last month before entry - Participants with a history of severe drug allergy, drug hypersensitivity, or neuroleptic malignant (cancerous) syndrome - Participants with known hypersensitivity to risperidone - Participants with acute risk of suicide at study entry or a history of suicidal attempt(s)