A Phase 2 interventional study of Ziprasidone in Schizophrenia, sponsored by University of North Carolina, Chapel Hill. Completed at 4 sites in United States. Open to participants aged 6 Years to 19 Years. Per ClinicalTrials.gov, last updated 2024-08-15.
Sponsored by University of North Carolina, Chapel Hill · Phase 2, Interventional, and Treatment
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.
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.
3,539 studies on the registry are indexed under Schizophrenia; 473 are open to participants now.
This study's enrollment of 40 is below the median of 70 across 2,924 interventional studies indexed under Schizophrenia.
Browse Schizophrenia studies →University of North Carolina, Chapel Hill is the lead sponsor of 1,366 studies on the registry; 133 are open to participants now.
Of its 158 completed or terminated interventional studies of FDA-regulated products, 139 (88%) have results posted.
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Drug: Ziprasidone
20mg pills, dosing will be flexible, ranging from 10 to 160 mg divided BID or TID for the duration of the 52 week trial. In very rare cases, if the subject has shown some benefit and no side effects at a dose of 160mg and the treating clinician feels a further dose increase is necessary, the case would need to be presented to all of the other Principal Investigators for special consideration of further dose increases in 20 mg increments to an absolute maximal dose of 220mg.
Also known as: Geodon
The primary outcome measure will be responder status, defined as a CGI improvement score of 1 or 2, plus a 20 % reduction in the baseline PANSS score at week 8.
Time frame: 8 weeks
A correlational analysis will be done to examine the potential relationship between dose and treatment response, and reduction in positive and negative symptoms.
Time frame: 52 weeks
Subsequent analyses will examine the ZEOSS week 0 visit scores to assess for further improvement in symptoms and ability to sustain response/prevent relapse in subjects who responded to but could not tolerate the prior antipsychotic.
Time frame: 52 weeks
The record gives a start of Dec 2002, a primary completion of Feb 2006 and a completion of Feb 2006. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Nov 2009. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ziprasidone
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