NCT01624675

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Sep 2012

Geographic Reach
1 country

17 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 19, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 21, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2012

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

October 15, 2015

Status Verified

October 1, 2015

Enrollment Period

2.1 years

First QC Date

June 19, 2012

Last Update Submit

October 13, 2015

Conditions

Autistic Disorder in Children and Adolescents

Keywords

Autistic disorder in children and adolescentsRisperidone (R064766)ChildrenAdolescentsIrritabilityAutistic disorder

Outcome Measures

Primary Outcomes (1)

  • The change from baseline in the Aberrant Behavior Checklist-Japanese Version (ABC-J) Irritability Subscale scores

    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.

    Baseline, Week 8

Secondary Outcomes (10)

  • The changes from baseline in the subscale scores of Aberrant Behavior Checklist-Japanese Version (ABC-J) at each evaluation of the double-blind phase

    Baseline, Week 2, Week 4, Week 6

  • The changes from baseline in the subscale scores of Aberrant Behavior Checklist-Japanese Version (ABC-J) at each evaluation of the open-label phase

    Baseline, Week 2, Week 4, Week 8, Week 16, Week 24, Week 32, Week 40, Week 48

  • The changes from baseline in scores of the Clinical Global Impression - Severity (CGI-S) at each evaluation time point of the double-blind phase

    Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8

  • The changes from baseline in scores of the Clinical Global Impression - Severity (CGI-S) at each evaluation time point of the open-label-phase

    Baseline, Week 1, Week 2, Week 3, Week 4, Week 8, Week 16, Week 24, Week 32, Week 40, Week 48

  • 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

    Baseline, Week 4, Week 8

  • +5 more secondary outcomes

Study Arms (2)

Risperidone

EXPERIMENTAL

Subjects weighing less than 20 kilogram (kg) received risperidone 0.25 milligram per day (mg/day) up to Day 4. On Day 4, dose was titrated in increments of 0.25 mg/day (up to a daily dose of 1.0 mg) at the regular study visit thereafter till Week 8. Subjects weighing greater than or equal to (\>=) 20 kg received risperidone 0.5 mg/day up to Day 4. On Day 4, dose was titrated in increments of 0.5 mg per day (up to a daily dose of 2.5 mg) at the regular visit thereafter till Week 8. The maximum daily dose for subjects weighing \>= 45 kg was 3.0 mg. For subjects weighing \>=45 kg, the maximum daily dose was 3.0 mg.

Drug: Risperidone

Placebo

PLACEBO COMPARATOR

Subjects will receive placebo matching with risperidone orally up to 8 weeks.

Drug: Placebo

Interventions

RisperidoneDRUG

Subjects weighing less than 20 kilogram (kg) received risperidone 0.25 milligram per day (mg/day) up to Day 4. On Day 4, dose was titrated in increments of 0.25 mg/day (up to a daily dose of 1.0 mg) at the regular study visit thereafter till Week 8. Subjects weighing greater than or equal to (\>=) 20 kg received risperidone 0.5 mg/day up to Day 4. On Day 4, dose was titrated in increments of 0.5 mg per day (up to a daily dose of 2.5 mg) at the regular visit thereafter till Week 8. The maximum daily dose for subjects weighing \>= 45 kg was 3.0 mg. For subjects weighing \>=45 kg, the maximum daily dose was 3.0 mg.

Risperidone
PlaceboDRUG

Subjects will receive placebo matching with risperidone orally up to 8 weeks.

Placebo

Eligibility Criteria

Age5 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Unknown Facility

Fuchū, Japan

Location

Unknown Facility

Fukui, Japan

Location

Unknown Facility

Hirakata, Japan

Location

Unknown Facility

Ichikawa, Japan

Location

Unknown Facility

Kanzaki, Japan

Location

Unknown Facility

Kobe, Japan

Location

Unknown Facility

Kodaira, Japan

Location

Unknown Facility

Kurashiki, Japan

Location

Unknown Facility

Neyagawa, Japan

Location

Unknown Facility

Okayama, Japan

Location

Unknown Facility

Sakai, Japan

Location

Unknown Facility

Shimotsuke, Japan

Location

Unknown Facility

Tokyo, Japan

Location

Unknown Facility

Toyama, Japan

Location

Unknown Facility

Tsu, Japan

Location

Unknown Facility

Tsuyama, Japan

Location

Unknown Facility

Yokohama, Japan

Location

Related Publications (1)

  • Iffland M, Livingstone N, Jorgensen M, Hazell P, Gillies D. Pharmacological intervention for irritability, aggression, and self-injury in autism spectrum disorder (ASD). Cochrane Database Syst Rev. 2023 Oct 9;10(10):CD011769. doi: 10.1002/14651858.CD011769.pub2.

    PMID: 37811711DERIVED

Related Links

MeSH Terms

Conditions

Autistic Disorder

Interventions

Risperidone

Condition Hierarchy (Ancestors)

Autism Spectrum DisorderChild Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Janssen Pharmaceutical K.K., Japan Clinical Trial

    Janssen Pharmaceutical K.K.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2012

First Posted

June 21, 2012

Study Start

September 1, 2012

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

October 15, 2015

Record last verified: 2015-10

Locations

JP(17)