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Ziprasidone in Children With Autism: A Pilot Study

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ClinicalTrials.gov Identifier: NCT00208559
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : June 17, 2010
Sponsor:
Information provided by:
Drexel University

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

Condition or disease Intervention/treatment Phase
Autism Drug: Ziprasidone Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ziprasidone in Children With Autism: A Pilot Study
Study Start Date : February 2002
Primary Completion Date : June 2005
Study Completion Date : August 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
1 Open Label
Open Label
Drug: Ziprasidone
Ziprasidone 40mg to 60mg per day, individually titrated
Other Name: Geodon



Primary Outcome Measures :
  1. Clinical Global Impressions [ Time Frame: Week 6 ]

Secondary Outcome Measures :
  1. Children's Psychiatric Rating Scale [ Time Frame: Baseline, Week 6 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00208559


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

Responsible Party: Richard P. Malone, Drexel University College of Medicine
ClinicalTrials.gov Identifier: NCT00208559     History of Changes
Other Study ID Numbers: 00936
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: June 17, 2010
Last Verified: June 2010

Keywords provided by Drexel University:
Autism
Pervasive Developmental Disorder
Ziprasidone
Adolescents

Additional relevant MeSH terms:
Autistic Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders
Ziprasidone
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents