A Study to Evaluate the Efficacy and Safety of Risperidone (R064766) in Children and Adolescents With Irritability Associated With Autistic Disorder

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Janssen Pharmaceutical K.K.
ClinicalTrials.gov Identifier:
NCT01624675
First received: June 19, 2012
Last updated: June 12, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Autistic Disorder in Children and Adolescents
Drug: Risperidone
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Janssen Pharmaceutical K.K.:

Primary Outcome Measures:
  • The change from baseline in the Aberrant Behavior Checklist−Japanese Version (ABC-J) Irritability Subscale scores [ Time Frame: Baseline, Week 8 ] [ Designated as safety issue: No ]
    The ABC-J Irritability subscale consists of 15 items. Each item scores range from 0 to 3: 0 = No problem, 1 = Mild aberrant behavior, 2 = Moderate aberrant behavior, and 3 = Severe aberrant behavior. Higher scores represent worse condition.


Secondary Outcome Measures:
  • The changes from baseline in the subscale scores of Aberrant Behavior Checklist-Japanese Version (ABC-J) at each evaluation of the double-blind phase [ Time Frame: Baseline, Week 2, Week 4, Week 6 ] [ Designated as safety issue: No ]
    The ABC-J consists of 58 items divided into 5 subscales: Irritability, Lethargy and Social withdrawal, Stereotypic behavior, Hyperactivity/Noncompliance, and Inappropriate speech. Each item scores range from 0 to 3: 0 = No problem, 1 = Mild aberrant behavior, 2 = Moderate aberrant behavior, and 3 = Severe aberrant behavior. Higher scores represent worse condition.

  • The changes from baseline in the subscale scores of Aberrant Behavior Checklist-Japanese Version (ABC-J) at each evaluation of the open-label phase [ Time Frame: Baseline, Week 2, Week 4, Week 8, Week 16, Week 24, Week 32, Week 40, Week 48 ] [ Designated as safety issue: No ]
    The ABC-J consists of 58 items divided into 5 subscales: Irritability, Lethargy and Social withdrawal, Stereotypic behavior, Hyperactivity/Noncompliance, and Inappropriate speech. Each item scores range from 0 to 3: 0 = No problem, 1 = Mild aberrant behavior, 2 = Moderate aberrant behavior, and 3 = Severe aberrant behavior. Higher scores represent worse condition.

  • The changes from baseline in scores of the Clinical Global Impression - Severity (CGI-S) at each evaluation time point of the double-blind phase [ Time Frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8 ] [ Designated as safety issue: No ]
    The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a patient. A rating of 1 is equivalent to "Normal, not at all ill" and a rating of 7 is equivalent to "Among the most extremely ill patients". Higher scores indicate worsening.

  • The changes from baseline in scores of the Clinical Global Impression - Severity (CGI-S) at each evaluation time point of the open-label-phase [ Time Frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 8, Week 16, Week 24, Week 32, Week 40, Week 48 ] [ Designated as safety issue: No ]
    The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a patient. A rating of 1 is equivalent to "Normal, not at all ill" and a rating of 7 is equivalent to "Among the most extremely ill patients". Higher scores indicate worsening.

  • 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 [ Time Frame: Baseline, Week 4, Week 8 ] [ Designated as safety issue: No ]
    The C-GAS rates the patient's general psychological and social functioning on scores ranging from 1 through 100. Lower scores (range 1-10) mean that the patient needs constant supervision; higher scores (range 91-100) mean that the patient has a superior functioning in all areas.

  • The changes from baseline in scores of the Children's Global Assessment Scale (C-GAS) at each evaluation time point of open-label-phase [ Time Frame: Baseline, Week 4, Week 8, Week 16, Week 24, Week 32, Week 40, Week 48 ] [ Designated as safety issue: No ]
    The C-GAS rates the patient's general psychological and social functioning on scores ranging from 1 through 100. Lower scores (range 1-10) mean that the patient needs constant supervision; higher scores (range 91-100) mean that the patient has a superior functioning in all areas.

  • The Clinical Global Impression−Change (CGI-C) at each evaluation time point of the double-blind phase [ Time Frame: Week 1, Week 2, Week 3, Week 4, Week 6, Week 8 ] [ Designated as safety issue: No ]
    The CGI-C assesses the patient's condition on the basis of the rater's impression, on a 7-point scale ranging from 1 (Very much improved) to 7 (Very much worse).

  • The Clinical Global Impression−Change (CGI-C) at each evaluation time point of the open label-phase [ Time Frame: Week 1, Week 2, Week 3, Week 4, Week 8, Week 16, Week 24, Week 32, Week 40, Week 48 ] [ Designated as safety issue: No ]
    The CGI-C assesses the patient's condition on the basis of the rater's impression, on a 7-point scale ranging from 1 (Very much improved) to 7 (Very much worse).

  • The Parent Satisfaction Questionnaire (PSQ) at each evaluation time point of the double-blind phase [ Time Frame: Week 1, Week 2, Week 3, Week 4, Week 6, Week 8 ] [ Designated as safety issue: No ]
    The PSQ evaluates the caregiver's satisfaction with the study drug.

  • The Parent Satisfaction Questionnaire (PSQ) at each evaluation time point of the open label-phase [ Time Frame: 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 ] [ Designated as safety issue: No ]
    The PSQ evaluates the caregiver's satisfaction with the study drug.


Enrollment: 39
Study Start Date: September 2012
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Risperidone Drug: Risperidone

Patients weighing <20 kg will start with 0.25 mg, once daily. The dose will be increased to 0.5 mg per day (0.25 mg twice daily) on Day 4. The dose will be titrated in increments of 0.25 mg per day (up to a daily dose of 1.0 mg) at the regular study visit thereafter.

Patients weighing=>20 kg will start with 0.5 mg, once daily. The dose will be increased to 1.0 mg per day (0.5 mg twice daily) on Day 4. The dose will be titrated in increments of 0.5 mg per day (up to a daily dose of 2.5 mg) at the regular study visit thereafter. The maximum daily dose for patient weighing =>45 kg will be 3.0 mg.

Placebo Comparator: Placebo Drug: Placebo

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

Ages Eligible for Study:   5 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01624675

Locations
Japan
Fuchu, Japan
Fukui, Japan
Hirakata, Japan
Ichikawa, Japan
Kanzaki, Japan
Kobe, Japan
Kodaira, Japan
Kurashiki, Japan
Neyagawa, Japan
Okayama, Japan
Sakai, Japan
Shimotsuke, Japan
Tokyo, Japan
Toyama, Japan
Tsu, Japan
Tsuyama, Japan
Yokohama, Japan
Sponsors and Collaborators
Janssen Pharmaceutical K.K.
Investigators
Study Director: Janssen Pharmaceutical K.K., Japan Clinical Trial Janssen Pharmaceutical K.K.
  More Information

No publications provided

Responsible Party: Janssen Pharmaceutical K.K.
ClinicalTrials.gov Identifier: NCT01624675     History of Changes
Other Study ID Numbers: CR100877, RIS-AUT-JPN-01
Study First Received: June 19, 2012
Last Updated: June 12, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Janssen Pharmaceutical K.K.:
Autistic disorder in children and adolescents
Risperidone (R064766)
Children
Adolescents
Irritability
Autistic disorder

Additional relevant MeSH terms:
Autistic Disorder
Child Development Disorders, Pervasive
Mental Disorders Diagnosed in Childhood
Mental Disorders
Risperidone
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on July 22, 2014