Safety And Efficacy Study Of Ziprasidone In Pediatric Psychotic Illness

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00199940
• Other study ID #: CHW 03/162, HRRC 538-03
• 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
• 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

Related Conditions & MeSH terms

• Affective Disorders
• Affective Disorders, Psychotic
• Disease
• Mental Disorders
• Mood Disorders
• Psychotic Disorder
• Psychotic Disorders
• Psychotic Mood Disorder
• Schizophrenia

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.