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

PHASE3CompletedINTERVENTIONAL
Enrollment

39

Participants

Timeline

Start Date

September 30, 2012

Primary Completion Date

October 31, 2014

Study Completion Date

October 31, 2014

Conditions
Autistic Disorder in Children and Adolescents
Interventions
DRUG

Risperidone

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

Placebo

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

Trial Locations (17)

Unknown

Fuchū

Fukui

Hirakata

Ichikawa

Kanzaki

Kobe

Kodaira

Kurashiki

Neyagawa

Okayama

Sakai

Shimotsuke

Tokyo

Toyama

Tsu

Tsuyama

Yokohama

Sponsors
All Listed Sponsors
lead

Janssen Pharmaceutical K.K.

INDUSTRY

NCT01624675 - A Study to Evaluate the Efficacy and Safety of Risperidone (R064766) in Children and Adolescents With Irritability Associated With Autistic Disorder | Biotech Hunter | Biotech Hunter