NCT00199940

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 weight changes in children.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_4 schizophrenia

Timeline
Completed

Started Dec 2003

Typical duration for phase_4 schizophrenia

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2003

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
Last Updated

March 12, 2008

Status Verified

March 1, 2008

First QC Date

September 13, 2005

Last Update Submit

March 6, 2008

Conditions

SchizophreniaAffective DisordersPsychotic DisorderPsychotic Mood Disorder

Keywords

SchizophreniaPediatric psychotic disordersZiprasidone

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (6)

  • 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.

  • +1 more secondary outcomes

Interventions

ZiprasidoneDRUG

Eligibility Criteria

Age7 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

SchizophreniaMood DisordersPsychotic DisordersAffective Disorders, Psychotic

Interventions

ziprasidone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Russell E Scheffer, MD

    Medical College of Wisconsin; Children's Hospital of Wisconsin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 20, 2005

Study Start

December 1, 2003

Study Completion

April 1, 2007

Last Updated

March 12, 2008

Record last verified: 2008-03