Autistic disorder in children and adolescents MedDRA version: 17.1 Level: LLT Classification code 10003808 Term: Autistic disorder System Organ Class: 100000004852
Conditions
Interventions
Trade Name: RISPERDAL
Pharmaceutical Form: Oral solution
INN or Proposed INN: RISPERIDONE
Other descriptive name: RISPERIDONE
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equa
Sponsors
Janssen Pharmaceutical K.K
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Diagnostic for autistic disorder - A Clinical Global Impression - Severity (CGI-S) score of =>4 and an Aberrant Behavior Checklist - Japanese Version (ABC-J) Irritability Subscale score of =>18 - Patients with mental age of >18 months as measured by appropriate developmental or mental scales - Patients who have an appropriate caregiver, eg, parent or study-site personnel, who is able to observe the patient’s condition, provide information, and evaluate the patient’s response appropriately Are the trial subjects under 18? yes Number of subjects for this age range: 39 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Patients with previous or current psychotic disorder (eg, schizophrenia, bipolar disorder, or other psychiatric disorders) or with pervasive developmental disorder not otherwise specified, Asperger’s disorder, Rett’s disorder, pediatric destructive behavior disorder, or substance dependence - Patients with a clinically significant endocrine, metabolic, cardiac, hepatic, renal, or pulmonary disorder, or hypertension - Weight of 450 msec in the standard 12-lead electrocardiogram (ECG) at the time of screening - Patients with known hypersensitivity to risperidone or paliperidone
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The purpose of this study is to evaluate the efficacy of risperidone compared with placebo in children and adolescents with irritability associated with autistic disorder.;Secondary Objective: Not applicable;Primary end point(s): The change from baseline in the Aberrant Behavior Checklist-Japanese Version (ABC-J) Irritability Subscale scores;Timepoint(s) of evaluation of this end point: Baseline, Week 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - The changes from baseline in the subscale scores of Aberrant Behavior Checklist-Japanese Version (ABC-J) at each evaluation of the double-blind phase - The changes from baseline in the subscale scores of Aberrant Behavior Checklist-Japanese Version (ABC-J) at each evaluation of the open-label phase - The changes from baseline in scores of the Clinical Global Impression – Severity (CGI-S) at each evaluation time point of the double-blind phase - The changes from baseline in scores of the Clinical Global Impression – Severity (CGI-S) at each evaluation time point of the open-label-phase - The changes from baseline in scores of the Children's Global Assessment Scale (C-GAS) at each evaluation time point of the double-blind phase and open-label-phase - The changes from baseline in scores of the Children's Global Assessment Scale (C-GAS) at each evaluation time point of open-label-phase - The Clinical Global Impression-Change (CGI-C) at each evaluation time point of the double-blind phase - The Clinical Global Impression-Change (CGI-C) at each evaluation time point of the open label-phase - The Parent Satisfaction Questionnaire (PSQ) at each evaluation time point of the double-blind phase - The Parent Satisfaction Questionnaire (PSQ) at each evaluation time point of the open label-phase;Timepoint(s) of evaluation of this end point: - Baseline, Week 2, Week 4, Week 6 - Baseline, Week 2, Week 4, Week 8, Week 16, Week 24, Week 32, Week 40, Week 48 - Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8 - Baseline, Week 1, Week 2, Week 3, Week 4, Week 8, Week 16, Week 24, Week 32, Week 40, Week 48 - Baseline, Week 4, Week 8 - Baseline, Week 4, Week 8, Week 16, Week 24, Week 32, Week 40, Week 48 - Week 1, Week 2, Week 3, Week 4, Week 6, Week 8 - Week 1, Week 2, Week 3, Week 4, Week 8, Week 16, Week 24, Week 32, Week 40, Week 48 - Week 1, Week 2, Week 3, Week 4, Week 6, Week 8 - Week 1, Week 2, Week 3, Week 4, Week 8, Week 12, We | — |
Countries
Japan
Contacts
Public ContactClinical Registry Group-JB BV
Janssen Research and Development
Outcome results
None listed