MedTrace Logo

Study of Paliperidone ER in Adolescents and Young Adults With Autism

NCT00549562 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2017-05-16

Study results available
· View outcomes & findings →

Summary

This 8-week, prospective open-label study will investigate the effectiveness and tolerability of paliperidone ER in adolescents and young adults with autism. Hypothesis:Paliperidone Er will be well tolerated and efficacious for reducing aggression, self-injury, and irritability in adolescents and young adults.

Conditions

Interventions

DRUG

Paliperidone ER

Starting dose is 3 mg per day. Can be titrated up to a maximum dose of 9 mg per day.

Sponsors & Collaborators

  • Ortho-McNeil Janssen Scientific Affairs, LLC

    collaborator INDUSTRY

  • Indiana University School of Medicine

    lead OTHER

Principal Investigators

  • David Dunn, MD · Indiana Univerity School of Medicine

Study Design

Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
12 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2010-09-30
Completion
2010-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00549562 on ClinicalTrials.gov