Aripiprazole in Children With Autism: A Pilot Study - Full Text View

Sponsored by:	Drexel University
Information provided by:	Drexel University
ClinicalTrials.gov Identifier:	NCT00208533

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 II

MedlinePlus related topics: Autism

Drug Information available for: Aripiprazole

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Aripiprazole in Children With Autism: A Pilot Study

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

Eligibility

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:

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

Investigators

Principal Investigator:

Richard P Malone, MD

Drexel University College of Medicine

More Information

Responsible Party:	Drexel University College of Medicine ( Richard P. Malone, M.D. )
Study ID Numbers:	02841
Study First Received:	September 13, 2005
Last Updated:	January 28, 2009
ClinicalTrials.gov Identifier:	NCT00208533
Health Authority:	United States: Institutional Review Board

Keywords provided by Drexel University:

Autism
Pervasive developmental disorder
Aripiprazole
Antipsychotic medication
Adolescents

Study placed in the following topic categories:

Child Development Disorders, Pervasive
Developmental Disabilities
Mental Disorders

Autistic Disorder
Mental Disorders Diagnosed in Childhood
Aripiprazole

Additional relevant MeSH terms:

Tranquilizing Agents
Therapeutic Uses
Physiological Effects of Drugs
Psychotropic Drugs

Central Nervous System Depressants
Antipsychotic Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 06, 2009