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Aripiprazole in Children With Autism: A Pilot Study

This study has been completed.
Sponsor:
Information provided by:
Drexel University
ClinicalTrials.gov Identifier:
NCT00208533
First received: September 13, 2005
Last updated: April 6, 2009
Last verified: January 2009
History of Changes
  Purpose

This is a 6-week open pilot study of aripiprazole for the treatment of adolescents, aged 12 to 18 years, diagnosed with autism.

Children who qualify for the study will be treated with aripiprazole for 6 weeks.

Treatment is provided at no cost.


Condition Intervention Phase
Autism
 Drug: Aripiprazole
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Aripiprazole in Children With Autism: A Pilot Study

Resource links provided by NLM:

MedlinePlus related topics: Autism
U.S. FDA Resources

Further study details as provided by Drexel University:

Primary Outcome Measures:
  • Clinical Global Impressions [ Time Frame: Week 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Children's Psychiatric Rating Scale [ Time Frame: Baseline, Week 6 ] [ Designated as safety issue: No ]

Enrollment: 11
Study Start Date: February 2004
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1 Open Label
Open Label Aripiprazole
 Drug: Aripiprazole
Aripiprazole 5 mg to 30mg, individually titrated
Other Name: Abilify

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   12 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of autism (DSM-IV) made by a boarded child and adolescent psychiatrist.
  • Males and females.
  • Aged 12 to 18 years.
  • Clinical judgment that medication treatment for autism is indicated.

Exclusion Criteria:

  • Major medical problems including cardiac, liver, endocrine, or renal diseases.
  • Uncontrolled seizures.
  • Baseline QTC greater than 425 msec.
  • Concomitant treatment with psychotropic medication.
  • History of prior exposure to aripiprazole.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00208533

Locations
United States, Pennsylvania
Drexel University College of Medicine at Friends Hospital
Philadelphia, Pennsylvania, United States, 19124
Sponsors and Collaborators
Drexel University College of Medicine
Investigators
Principal Investigator: Richard P Malone, MD Drexel University College of Medicine
  More Information

No publications provided

Responsible Party: Richard P. Malone, M.D., Drexel University College of Medicine
ClinicalTrials.gov Identifier: NCT00208533     History of Changes
Other Study ID Numbers: 02841
Study First Received: September 13, 2005
Last Updated: April 6, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Drexel University:
Autism
Pervasive developmental disorder
Aripiprazole
Antipsychotic medication
Adolescents

Additional relevant MeSH terms:
Autistic Disorder
Child Development Disorders, Pervasive
Mental Disorders Diagnosed in Childhood
Mental Disorders
Aripiprazole
Antipsychotic Agents
Tranquilizing Agents
 Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on May 19, 2013