CompletedPhase 4

Safety And Efficacy Study Of Ziprasidone In Pediatric Psychotic Illness

20 participantsStarted 2003-12

Plain-language 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.

Who can participate

Age range7 Years – 17 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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

Trial details

NCT IDNCT00199940

SponsorMedical College of Wisconsin

Sponsor typeOTHER

Study typeINTERVENTIONAL

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