Ziprasidone in Children With Autism: A Pilot Study

This study has been completed.
Sponsor:
Information provided by:
Drexel University
ClinicalTrials.gov Identifier:
NCT00208559
First received: September 13, 2005
Last updated: June 15, 2010
Last verified: June 2010
  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 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: Ziprasidone in Children With Autism: A Pilot Study

Resource links provided by NLM:


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
Other Name: Geodon

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 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, Drexel University College of Medicine
ClinicalTrials.gov Identifier: NCT00208559     History of Changes
Other Study ID Numbers: 00936
Study First Received: September 13, 2005
Last Updated: June 15, 2010
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on September 22, 2014