Clinical trial NCT01624675: A Study to Evaluate the Efficacy and Safety of Risperidone (R064766) in Children and Adolescents With Irritability Associated With Autistic Disorder
Official title: A Double-blind, Placebo-controlled Study, Followed by an Open-label Extension Study Evaluating the Efficacy and Safety of Risperidone (R064766) in Children and Adolescents With Irritability Associated With Autistic Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Autistic Disorder in Children and Adolescents
Keywords: Autistic disorder in children and adolescents
Risperidone (R064766)
Children
Adolescents
Irritability
Autistic disorder
Lead sponsor: Janssen Pharmaceutical K.K.
Sponsor class: INDUSTRY
First posted: 2012-06-21
Enrollment: 39
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: This is a randomized (the drug is assigned by chance), 8-week, double-blind (neither physician nor patient knows the treatment that the patient receives), placebo-controlled (placebo is an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial), parallel-group (each group of patients will be treated at the same time), flexible-dose, multicenter study. It will be followed by a 48-week, flexible-dose, open-label (all people know the identity of the intervention) extension, to evaluate the efficacy and safety of risperidone in children and adolescents with a diagnosis of autistic disorder (severe form of pervasive developmental disorder) who have associated irritability. The study consists of up to 2-week screening phase, an 8-week double-blind phase, a 48-week open-label phase, and a 1-week follow-up phase.

Eligibility 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

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 \<15 kg at the time of screening and baseline
* Patients with QTc\>450 msec in the standard 12-lead electrocardiogram (ECG) at the time of screening
* Patients with known hypersensitivity to risperidone or paliperidone

Primary outcomes:
measure: The change from baseline in the Aberrant Behavior Checklist-Japanese Version (ABC-J) Irritability Subscale scores
timeFrame: Baseline, Week 8
Secondary outcomes:
measure: The changes from baseline in the subscale scores of Aberrant Behavior Checklist-Japanese Version (ABC-J) at each evaluation of the double-blind phase
timeFrame: Baseline, Week 2, Week 4, Week 6
measure: The changes from baseline in the subscale scores of Aberrant Behavior Checklist-Japanese Version (ABC-J) at each evaluation of the open-label phase
timeFrame: Baseline, Week 2, Week 4, Week 8, Week 16, Week 24, Week 32, Week 40, Week 48
measure: The changes from baseline in scores of the Clinical Global Impression - Severity (CGI-S) at each evaluation time point of the double-blind phase
timeFrame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8
measure: The changes from baseline in scores of the Clinical Global Impression - Severity (CGI-S) at each evaluation time point of the open-label-phase
timeFrame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 8, Week 16, Week 24, Week 32, Week 40, Week 48
measure: 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
timeFrame: Baseline, Week 4, Week 8
measure: The changes from baseline in scores of the Children's Global Assessment Scale (C-GAS) at each evaluation time point of open-label-phase
timeFrame: Baseline, Week 4, Week 8, Week 16, Week 24, Week 32, Week 40, Week 48
measure: The Clinical Global Impression-Change (CGI-C) at each evaluation time point of the double-blind phase
timeFrame: Week 1, Week 2, Week 3, Week 4, Week 6, Week 8
measure: The Clinical Global Impression-Change (CGI-C) at each evaluation time point of the open label-phase
timeFrame: Week 1, Week 2, Week 3, Week 4, Week 8, Week 16, Week 24, Week 32, Week 40, Week 48
measure: The Parent Satisfaction Questionnaire (PSQ) at each evaluation time point of the double-blind phase
timeFrame: Week 1, Week 2, Week 3, Week 4, Week 6, Week 8
measure: The Parent Satisfaction Questionnaire (PSQ) at each evaluation time point of the open label-phase
timeFrame: Week 1, Week 2, Week 3, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44, Week 48
Other outcomes:
Locations:
city: Fuchu
country: Japan
city: Fukui
country: Japan
city: Hirakata
country: Japan
city: Ichikawa
country: Japan
city: Kanzaki
country: Japan
city: Kobe
country: Japan
city: Kodaira
country: Japan
city: Kurashiki
country: Japan
city: Neyagawa
country: Japan
city: Okayama
country: Japan
city: Sakai
country: Japan
city: Shimotsuke
country: Japan
city: Tokyo
country: Japan
city: Toyama
country: Japan
city: Tsuyama
country: Japan
city: Tsu
country: Japan
city: Yokohama
country: Japan
Study officials:
affiliation: Janssen Pharmaceutical K.K.
name: Janssen Pharmaceutical K.K., Japan Clinical Trial
role: STUDY_DIRECTOR
References: