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Ziprasidone in Early Onset Schizophrenia Spectrum Disorders

2014-08-27 03:18:15 | BioPortfolio

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.

Description

The study will consist of two phases: an eight week acute phase and a 44 week continuation phase for those subjects who show a response during the first eight weeks. All treatment will be open label and monitored by research clinicians with expertise in treating psychotic youth. The initial titration is relatively slow to minimize side effects. A flexible dose strategy in which each individual's ultimate dose is determined by his/her response and side effects will be used. The maximal dose will be 160mg split as a BID dose. We estimate that the average dose will be 120mg/d. Concurrent use of benztropine, propranolol, and benzodiazepines (lorazepam and clonazepam) will be permitted as needed to treat any emergent extrapyramidal side effects and agitation. Concurrent use of antidepressants and mood stabilizers will be permitted in those subjects who have been on stable doses of antidepressants or mood stabilizers for at least four weeks at time of entry, or those with emergence of significant affective symptoms during the maintenance phase of the study.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Schizophrenia

Intervention

Ziprasidone

Location

Harvard University
Medford
Massachusetts
United States
02155

Status

Completed

Source

University of North Carolina, Chapel Hill

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:18:15-0400

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An antipsychotic agent used in schizophrenia.

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