Ziprasidone in Children With Autism: A Pilot Study

This study has been completed.

First Received: September 13, 2005 Last Updated: April 16, 2008 History of Changes

Sponsored by:	Drexel University
Information provided by:	Drexel University
ClinicalTrials.gov Identifier:	NCT00208559

Purpose

The purpose of this study is to see if the drug, ziprasidone, is effective in treating problems in adolescent associated with autism.

Condition	Intervention	Phase
Autism	Drug: Ziprasidone	Phase II

MedlinePlus related topics: Autism

Drug Information available for: Ziprasidone hydrochloride Ziprasidone Ziprasidone mesylate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Ziprasidone 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:	15
Study Start Date:	February 2002
Study Completion Date:	August 2006
Primary Completion Date:	June 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 Open Label Open Label	Drug: Ziprasidone Ziprasidone 40mg to 60mg per day, individually titrated

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.
History of seizure disorder or gross neurological deficit.
Baseline QTC greater than 425 msec.
Concomitant treatment with psychotropic medication.
History of prior exposure to ziprasidone.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00208559

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

No publications provided

Responsible Party:	Drexel University College of Medicine ( Richard P. Malone )
Study ID Numbers:	00936
Study First Received:	September 13, 2005
Last Updated:	April 16, 2008
ClinicalTrials.gov Identifier:	NCT00208559 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Drexel University:

Autism
Pervasive Developmental Disorder
Ziprasidone
Adolescents

Study placed in the following topic categories:

Developmental Disabilities
Neurotransmitter Agents
Tranquilizing Agents
Psychotropic Drugs
Central Nervous System Depressants
Antipsychotic Agents
Serotonin
Child Development Disorders, Pervasive

Dopamine
Autistic Disorder
Mental Disorders
Mental Disorders Diagnosed in Childhood
Dopamine Agents
Ziprasidone
Autism

Additional relevant MeSH terms:

Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Dopamine Antagonists
Antipsychotic Agents
Pharmacologic Actions
Child Development Disorders, Pervasive

Serotonin Antagonists
Serotonin Agents
Autistic Disorder
Mental Disorders
Therapeutic Uses
Mental Disorders Diagnosed in Childhood
Dopamine Agents
Ziprasidone
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 07, 2009