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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00199940
Other study ID # CHW 03/162, HRRC 538-03
Secondary ID
Status Completed
Phase Phase 4
First received September 13, 2005
Last updated March 6, 2008
Start date December 2003
Est. completion date April 2007

Study information

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

Clinical Trial 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 weight changes in children.


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 because early intervention in persons with a psychotic illness is important for their long-term treatment and outcome. Unfortunately, pediatric samples are often more sensitive to the side effects of psychotropic medications. Because psychotropic medications are often used by clinicians long before they are studied in pediatric populations, it is important to further study these agents.

Twenty subjects with the diagnosis of a psychotic disorder, according to DSM-IV criteria, will be recruited for the study. If subjects have completed baseline evaluations, labs, EKG, and rating scales and are still eligible to participate, subjects will start on 20mg of Ziprasidone at night. The second week this will increase to 20 mg twice a day. At visits that occur at 2,4,6,and 8 weeks, the subject's dose of medication can be increased in 20mg per day increments. This allows for a maximum possible dose of 100mg. Dosage may be decreased at any time secondary to side effects.

The potential benefits are that new information will be added to the field of pediatric psychiatry and the possibility that the medication may result in improved symptoms of psychosis. The potential benefits of this study outweigh the possible risks.


Recruitment information / eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
Ziprasidone


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Medical College of Wisconsin

Outcome

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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