A Prospective Study of the Clinical Outcome Following Treatment Discontinuation After Remission in First-Episode Schizophrenia

Janssen Cilag N.V./S.A0 sites33 target enrollmentMarch 31, 2015

Overview

No summary available.

Registry

who.int

Start Date

March 31, 2015

End Date

TBD

Last Updated

11 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Janssen Cilag N.V./S.A

•\- 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
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 33
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range 33
•F.1\.3 Elderly (\>\=65 years) no
•F.1\.3\.1 Number of subjects for this age range

•\- 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)