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Safety And Efficacy Study Of Ziprasidone In Pediatric Psychotic Illness

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00199940
First Posted: September 20, 2005
Last Update Posted: March 12, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Medical College of Wisconsin
  Purpose
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.

Condition Intervention Phase
Schizophrenia Affective Disorders Psychotic Disorder Psychotic Mood Disorder Drug: Ziprasidone Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Open Trial Of Ziprasidone, Early In The Course Of Pediatric Psychotic Illness

Resource links provided by NLM:


Further study details as provided by Medical College of Wisconsin:

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

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 20
Study Start Date: December 2003
Study Completion Date: April 2007
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00199940


Sponsors and Collaborators
Medical College of Wisconsin
Investigators
Principal Investigator: Russell E Scheffer, MD Medical College of Wisconsin; Children's Hospital of Wisconsin
  More Information

ClinicalTrials.gov Identifier: NCT00199940     History of Changes
Other Study ID Numbers: CHW 03/162, HRRC 538-03
First Submitted: September 13, 2005
First Posted: September 20, 2005
Last Update Posted: March 12, 2008
Last Verified: March 2008

Keywords provided by Medical College of Wisconsin:
Schizophrenia
Pediatric psychotic disorders
Ziprasidone

Additional relevant MeSH terms:
Disease
Schizophrenia
Mental Disorders
Psychotic Disorders
Mood Disorders
Affective Disorders, Psychotic
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Ziprasidone
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents