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Ziprasidone in Early Onset Schizophrenia Spectrum Disorders (ZEOSS)

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Ziprasidone
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia Spectrum Disorders

Eligibility Criteria

6 Years - 19 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Harvard University
  • University of North Carolina, Chapel Hill
  • Case Western Reserve University
  • University of Washington

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ziprasidone

Arm Description

Outcomes

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.

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.
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.

Full Information

First Posted
November 2, 2009
Last Updated
November 2, 2009
Sponsor
University of North Carolina, Chapel Hill
Collaborators
Pfizer, National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT01006551
Brief Title
Ziprasidone in Early Onset Schizophrenia Spectrum Disorders
Acronym
ZEOSS
Official Title
Ziprasidone in Early Onset Schizophrenia Spectrum Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
November 2009
Overall Recruitment Status
Completed
Study Start Date
December 2002 (undefined)
Primary Completion Date
February 2006 (Actual)
Study Completion Date
February 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
Pfizer, National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizophrenia Spectrum Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ziprasidone
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Ziprasidone
Other Intervention Name(s)
Geodon
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Linmarie Sikich, MD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
Harvard University
City
Medford
State/Province
Massachusetts
ZIP/Postal Code
02155
Country
United States
Facility Name
University of North Carolina, Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Case Western Reserve University
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98125
Country
United States

12. IPD Sharing Statement

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Ziprasidone in Early Onset Schizophrenia Spectrum Disorders

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