Schizophrenia Clinical Trial
Official title:
A Pilot Open Trial Of Ziprasidone, Early In The Course Of Pediatric Psychotic Illness
Verified date | March 2008 |
Source | Medical College of Wisconsin |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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 weight changes in children.
Status | Completed |
Enrollment | 20 |
Est. completion date | April 2007 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 7 Years to 17 Years |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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 |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Medical College of Wisconsin |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Positive and Negative Symptom Scale (PANSS), score symptoms from baseline through end of study Week 8. | |||
Secondary | Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS), assess at baseline only. | |||
Secondary | Child Depression Rating Scale (CDRS), rate from baseline to Week 8. | |||
Secondary | Simpson-Angus Rating Scale (SARS), rate from baseline to Week 8. | |||
Secondary | Abnormal Involuntary Movement Scale (AIMS), rate at baseline, Weeks 2,4,6,8. | |||
Secondary | Barnes Akathesia Scale (BAS), rate from baseline through Week 8. | |||
Secondary | Side-Effect For Children & Adolescents (SEFCA), rate from baseline through Week 8. |
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