Safety And Efficacy Study Of Ziprasidone In Pediatric Psychotic Illness

March 6, 2008 updated by: Medical College of Wisconsin

A Pilot Open Trial Of Ziprasidone, Early In The Course Of Pediatric Psychotic Illness

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 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.

Study Type

Interventional

Enrollment

20

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Positive and Negative Symptom Scale (PANSS), score symptoms from baseline through end of study Week 8.

Secondary Outcome Measures

Outcome Measure
Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS), assess at baseline only.
Child Depression Rating Scale (CDRS), rate from baseline to Week 8.
Simpson-Angus Rating Scale (SARS), rate from baseline to Week 8.
Abnormal Involuntary Movement Scale (AIMS), rate at baseline, Weeks 2,4,6,8.
Barnes Akathesia Scale (BAS), rate from baseline through Week 8.
Side-Effect For Children & Adolescents (SEFCA), rate from baseline through Week 8.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical College of Wisconsin

Investigators

  • Principal Investigator: Russell E Scheffer, MD, Medical College of Wisconsin; Children's Hospital of Wisconsin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2003

Study Completion (Actual)

April 1, 2007

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 20, 2005

Study Record Updates

Last Update Posted (Estimate)

March 12, 2008

Last Update Submitted That Met QC Criteria

March 6, 2008

Last Verified

March 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHW 03/162, HRRC 538-03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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