Ziprasidone in Early Onset Schizophrenia Spectrum Disorders

NCT01006551 | Completed Phase 2 DMC

• 2 other identifiers: 02-08582002-0012
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 4

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.

Conditions

Schizophrenia

Keywords

Schizophrenia Spectrum Disorders

Outcome Measures

Primary Outcomes (1)

• 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.

  8 weeks

Secondary Outcomes (2)

• A correlational analysis will be done to examine the potential relationship between dose and treatment response, and reduction in positive and negative symptoms.

  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.

  52 weeks

Study Arms (1)

Ziprasidone

EXPERIMENTAL

Drug: Ziprasidone

Interventions

Ziprasidone DRUG

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

Ziprasidone

Eligibility Criteria

• Age: 6 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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 (Tikosyn), 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.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Pfizer: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (4)

Harvard University

Medford, Massachusetts, 02155, United States

Location

University of North Carolina, Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Case Western Reserve University

Cleveland, Ohio, 44106, United States

Location

University of Washington

Seattle, Washington, 98125, United States

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

ziprasidone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Linmarie Sikich, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2009
• First Posted: November 3, 2009
• Study Start: December 1, 2002
• Primary Completion: February 1, 2006
• Study Completion: February 1, 2006
• Last Updated: August 15, 2024

Record last verified: 2009-11

Locations

US (4)