Status:
COMPLETED
Safety And Efficacy Study Of Ziprasidone In Pediatric Psychotic Illness
Lead Sponsor:
Medical College of Wisconsin
Conditions:
Schizophrenia
Affective Disorders
Eligibility:
All Genders
7-17 years
Phase:
PHASE4
Brief Summary
The purpose of this research is to determine if Ziprasidone is safe and effective for use in children and adolescents with a psychotic illness, and to determine of Ziprasidone treatment leads to weigh...
Detailed Description
Ziprasidone is a recently FDA approved antipsychotic, and it holds promise in the treatment of pediatric psychosis due to its low liability for weight gain and other side effects. This is important be...
Eligibility Criteria
Inclusion
- Diagnosis of Schizophrenia, Schizophreniform DO, Schizoaffective DO or Psychotic Disorder NOS
- Male/female, ages 7.0-17 years old
- Normal intelligence, ability to provide assent and consent
- Not currently receiving adequate treatment
Exclusion
- Known hypersensitivity to ziprasidone (past failed trial)
- History of QTc prolongation
- Recent myocardial infarction
- Uncompensated heart failure
- Currently treated with other QTc prolonging medications
- Unstable medical illness
- If on diuretics, monitor regularly for hypokalemia
Key Trial Info
Start Date :
December 1 2003
Trial Type :
INTERVENTIONAL
End Date :
April 1 2007
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00199940
Start Date
December 1 2003
End Date
April 1 2007
Last Update
March 12 2008
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