Ziprasidone in Early Onset Schizophrenia Spectrum Disorders (ZEOSS)

This study has been completed.
Sponsor:
Collaborators:
Pfizer
Information provided by:
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01006551
First received: November 2, 2009
Last updated: NA
Last verified: November 2009
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Schizophrenia
Drug: Ziprasidone
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Ziprasidone in Early Onset Schizophrenia Spectrum Disorders

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: December 2002
Study Completion Date: February 2006
Primary Completion Date: February 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ziprasidone 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.
Other Name: Geodon

Detailed 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.

  Eligibility

Ages Eligible for Study:   6 Years to 19 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Between 6 and 19 years old, male or female.
  • Significant psychotic symptoms defined by a behavior score of at least 4 (moderate) on at least one of the psychotic items of Positive and Negative Symptom Scale (PANSS) at baseline.
  • Subjects will meet DSM IV criteria for schizophrenia, schizoaffective disorder, or schizophreniform disorder.
  • Subjects will be free of depot antipsychotic medication for at least six months.
  • Good physical health.
  • The subject gives informed assent for the study and his/her guardian is able and willing to give informed consent.
  • Mood stabilizing treatment (i.e., antidepressant, lithium, carbamazepine, valproate) will be permitted during the first eight weeks of the study only if the patient has been treated with the mood stabilizer for at least 30 days. Dosages will remain stable for the first 8 weeks unless change or discontinuation is clinically indicated.

Exclusion Criteria:

  • A primary diagnosis of substance abuse or dependence.
  • Known endocrinological or neurological conditions, which confound the diagnosis or are a contraindication to treatment with antipsychotics.
  • Subjects with a clear history of intolerance or nonresponsiveness to ziprasidone.
  • Subjects at serious, short term risk for suicide.
  • Subjects who are pregnant or who refuse to practice contraception during the study.
  • Subjects with known cardiac conduction problems especially prior QTc prolongation, known genetic risk for QTc prolongation or who are being treated with other agents that prolong the QTc. These agents include the antiarrhythmic agents: dofetilide (Tkosyn), sotalol (Betapace), quinidine (Quinaglute), or Class 1A and III antiarrhythmics; the antipsychotics mesoridazine (Serentil), thioridazine (Mellaril), chlorpromazine (Thorazine), droperidol (Inapsine), pimozide (Orap); the anti-infectives: sparfloxacin (Zagam), gatifloxacin (Tequin), moxifloxacin (Avelox), pentamidine (Pentam); the anti-malarials halofantrine (Halfan), mefloquine (Lariam); and arsenic trioxide (Trisenox), levomethadyl acetate (Orlaam), dolasetron mesylate (Anzemet), probucol (Lorelco-an antilipemic), and tacrolimus (Prograf).
  • Subjects with a diagnosis of a pervasive developmental disorder or an autism screening questionnaire score >15, must have clear hallucinations or delusions.
  • Subjects will be excluded if they meet criteria for a current major depressive episode.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01006551

Locations
United States, Massachusetts
Harvard University
Medford, Massachusetts, United States, 02155
United States, North Carolina
University of North Carolina, Chapel Hill
Chapel Hill, North Carolina, United States, 27599
United States, Ohio
Case Western Reserve University
Cleveland, Ohio, United States, 44106
United States, Washington
University of Washington
Seattle, Washington, United States, 98125
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Pfizer
Investigators
Principal Investigator: Linmarie Sikich, MD University of North Carolina, Chapel Hill
  More Information

No publications provided

Responsible Party: Linmarie Sikich, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01006551     History of Changes
Other Study ID Numbers: 2002-0012, 2002-0012
Study First Received: November 2, 2009
Last Updated: November 2, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by University of North Carolina, Chapel Hill:
Schizophrenia Spectrum Disorders

Additional relevant MeSH terms:
Schizophrenia
Mental Disorders Diagnosed in Childhood
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Ziprasidone
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on April 17, 2014