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

• Conditions: Schizophrenia; MedDRA version: 17.1Level: PTClassification code 10039626Term: SchizophreniaSystem Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2015-001221-16-Outside-EU/EEA
• Lead Sponsor: Janssen Cilag N.V./S.A

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03-31
• Last Update Posted: 7 April 2015

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 33

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
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

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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified