Safety And Efficacy Study Of Ziprasidone In Pediatric Psychotic Illness

This study has been completed.
Sponsor:
Information provided by:
Medical College of Wisconsin
ClinicalTrials.gov Identifier:
NCT00199940
First received: September 13, 2005
Last updated: March 6, 2008
Last verified: March 2008
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Ages Eligible for Study:   7 Years to 17 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00199940     History of Changes
Other Study ID Numbers: CHW 03/162, HRRC 538-03
Study First Received: September 13, 2005
Last Updated: March 6, 2008
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on October 23, 2014