Status:
COMPLETED
Ziprasidone in Children With Autism: A Pilot Study
Lead Sponsor:
Drexel University College of Medicine
Conditions:
Autism
Eligibility:
All Genders
12-18 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to see if the drug, ziprasidone, is effective in treating problems in adolescent associated with autism.
Detailed Description
I. SPECIFIC AIMS 1. To investigate the safety of clinical use of ziprasidone in children 2. To investigate the dosages that have been employed clinically. II. BACKGROUND AND SIGNIFICANCE Ziprasidon...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2006
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00208559
Start Date
February 1 2002
End Date
August 1 2006
Last Update
June 17 2010
Active Locations (1)
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1
Drexel University College of Medicine at Friends Hospital
Philadelphia, Pennsylvania, United States, 19124