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An Open-Label Trial of Aripiprazole in Autism Spectrum Disorders

NCT00308074 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2017-02-15

Study results available
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Summary

The aim of this study is to evaluate the efficacy, safety and tolerability of aripiprazole monotherapy in the treatment of children and adolescents suffering from Autism Spectrum Disorder (ASD) over a 12-week period. We hypothesize that aripiprazole may be helpful in reducing ASD-associated symptoms of anxiety and aggression, resulting in significant improvements in global outcome.

Conditions

  • Autism
  • Asperger's Disorder
  • Pervasive Developmental Disorder

Interventions

DRUG

Aripiprazole

open-label, flexible-dosing

Sponsors & Collaborators

Principal Investigators

  • Jean A Frazier, MD · Cambridge Health Alliance

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-02-28
Primary Completion
2008-12-31
Completion
2009-02-28

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

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 NCT00308074 on ClinicalTrials.gov