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Safety And Efficacy Study Of Ziprasidone In Pediatric Psychotic Illness

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00199940
Enrollment
20
Registered
2005-09-20
Start date
2003-12-31
Completion date
2007-04-30
Last updated
2008-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Affective Disorders, Psychotic Disorder, Psychotic Mood Disorder, Schizophrenia

Keywords

Schizophrenia, Pediatric psychotic disorders, Ziprasidone

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.

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.

Interventions

DRUGZiprasidone

Sponsors

Medical College of Wisconsin
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
7 Years to 17 Years
Healthy volunteers
No

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

Design outcomes

Primary

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

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026