drugset / Trial / NCT01006551
Ziprasidone in Early Onset Schizophrenia Spectrum Disorders
Phase 2
Completed
40 enrolled
University of North Carolina, Chapel Hill
National Institute of Mental Health (NIMH) · collabPfizer · collab
NaSingle-groupOpen-labelTreatment
Summary
This is an open trial of ziprasidone (ZIP) in children and adolescents. It is designed to provide pilot data on the magnitude of ZIP's antipsychotic effects in psychotic youth, dosing ranges, acute safety, and tolerability. This would then inform the design of a rigorous, randomized controlled trial of ZIP in the pediatric population. The primary study hypothesis is that the proportion of pediatric subjects responding to treatment with ziprasidone will be comparable or greater than reported in trials of ziprasidone in adults.
Timeline
- Start
- 2002-12
- Primary completion
- 2006-02
- Completion
- 2006-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ziprasidone | Small molecule | 10 mg | Oral |
| Subject | Ziprasidone | Small molecule | 160 mg | Oral |
| Subject | Ziprasidone | Small molecule | 220 mg | Oral |