Schizophrenia MedDRA version: 17.1 Level: PT Classification code 10039626 Term: Schizophrenia System Organ Class: 10037175 - Psychiatric disorders
Conditions
Interventions
Trade Name: RISPERDAL
Pharmaceutical Form: Tablet
INN or Proposed INN: RISPERIDONE
Other descriptive name: RISPERIDONE
Concentration unit: mg milligram(s)
Concentration type: up to
Concentration numbe
Sponsors
Janssen Cilag N.V./S.A
Eligibility
Sex/Gender
All
Inclusion 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 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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: Not applicable;Primary end point(s): - Time to Relapse After Discontinuation of Risperidone Long-Acting Injection (RLAI) in First-Episode Participants Successfully Treated for 24 Months With RLAI in Previous Study (RIS-PSY-301) (Period 1) - Percentage of Participants who Relapsed After Discontinuation of RLAI (Period 1) - Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score After Re-Initiation of RLAI, at Month 24 or EW (Period 2) - Time to Treatment Response After Re-Initiation of RLAI (Period 2);Timepoint(s) of evaluation of this end point: - Month 36 or early withdrawal (EW) - Month 36 or EW - Baseline and Month 24 or EW - Month 24 or EW | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: - Baseline and Month 36 or EW - Baseline and Month 24 or EW - Baseline and Month 36 or EW - Baseline and Month 24 or EW - Month 36 or EW - Month 24 or EW - Baseline and Month 36 or EW - Month 36 or EW - Baseline and Month 24 or EW - Month 24 or EW - Baseline and Month 36 or EW - Baseline and Month 24 or EW - Baseline and Month 36 or EW - Baseline and Month 24 or EW - Baseline and Month 36 or EW - Month 36 or EW - Baseline and Month 24 or EW - Month 24 or EW - Baseline and Month 36 or EW - Baseline and Month 24 or EW;Secondary end point(s): - Change From Baseline in PANSS Total Score and Subscales of PANSS at Month 36 or EW (Period 1) - Change From Baseline in PANSS Total Score and Subscales of PANSS at Month 24 or EW (Period 2) - Change From Baseline in Marder PANSS Subscales Score at Month 36 or EW (Period 1) - Change From Baseline in Marder PANSS Subscales Score at Month 24 or EW (Period 2) - Number of Participants With Disease Remission Based on PANSS (Period 1) - Number of Participants With Disease Remission Based on PANSS (Period 2) - Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at Month 36 or EW (Period 1) - Clinical Global Impression of Change (CGI-C) Score at Month 36 or EW (Period 1) - Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at Month 24 or EW (Period 2) - Clinical Global Impression of Change (CGI-C) Score in Period 2 at Month 24 or EW (Period 2) - Change From Baseline in Calgary Depression Scale Score for Schizophrenia (CDSS) at Month 36 or EW (Period 1) - Change From Baseline in Calgary Depression Scale Score for Schizophrenia (CDSS) at Month 24 or EW (Period 2) - Change From Baseline in Social and Occupational Functioning Assessment Scale (SOFAS) Score at Month 36 or EW (Period 1) - Change From Baseline in Social and Occupational Functioning Assessment Scale (SOFAS) Score at Month 24 or EW (Period 2) - Chang | — |
Countries
South Africa
Contacts
Public ContactClinical Registry Group-JB BV
Janssen Research and Development
Outcome results
None listed