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High-Dose Oral Ziprasidone Versus Conventional Dosing in Schizophrenia Patients With Residual Symptoms (HDZ)

This study is currently recruiting participants.
Verified by Massachusetts General Hospital, December 2007

Sponsors and Collaborators: Massachusetts General Hospital
Pfizer
Information provided by: Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00403546
  Purpose

The primary aims of this study are to assess tolerability of ziprasidone dose escalation to 320 mg/d compared to continued standard treatment (placebo) as measured by the Side Effect Checklist, Simpson Angus Scale for Extrapyramidal Symptoms (SAS), Barnes Akathisia Scale (BAS), serum prolactin concentrations, vital signs, EKG and completion rates and to assess whether ziprasidone dose escalation improves overall psychopathology compared to continued standard treatment as measured by the change from baseline in PANSS total score and response rates as defined by a 20% or greater reduction in PANSS total score.

The secondary aims of this study are to assess whether ziprasidone dose escalation improves psychotic symptoms compared to continued standard treatment as measured by the Positive Symptom Subscale of the PANSS, to assess whether ziprasidone dose escalation improves negative symptoms compared to standard treatment as measured by the Negative Symptom Subscale of the PANSS, to assess whether ziprasidone dose escalation improves depressive symptoms compared to continued standard treatment as measured by the Calgary Depression Rating Scale (CDRS), and to assess whether ziprasidone dose escalation improves overall functioning with the CGI-S, CGI-I, GAF and the Schizophrenia Cognition Rating Scale (SCoRS).


Condition Intervention Phase
Schizophrenia
Drug: Geodon
Phase III

MedlinePlus related topics:   Depression    Psychotic Disorders    Schizophrenia   

ChemIDplus related topics:   Ziprasidone    Ziprasidone hydrochloride    Ziprasidone mesylate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment, Safety/Efficacy Study
Official Title:   High-Dose Oral Ziprasidone Versus Conventional Dosing in Schizophrenia Patients With Residual Symptoms

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Tolerability as measured by the Simpson Angus Scale for Extrapyramidal Symptoms (SAS), the Barnes Akathisia Scale (BAS), serum prolactin concentrations, vital signs, EKG and completion rates. [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Assess improvements in psychotic and/or negative symptoms as measured by change from baseline on the Positive Symptom Subscale of the PANSS. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Assess depressive symptoms as measured by change from baseline on the Calgary Depression Rating Scale (CDRS). [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Assess changes in overall functioning as measured by the CGI-S, the CGI-I,the GAF, and the Schizophrenia Cognition Rating Scale (SCoRS) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:   80
Study Start Date:   January 2006
Estimated Study Completion Date:   December 2009

Intervention Details:
    Drug: Geodon
    Geodon 160mg or placebo bid
Show detailed description  Show Detailed Description

  Eligibility
Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • Schizophrenia or Schizoaffective disorder, any subtype.
  • Age 18-65 years
  • Treated with ziprasidone at a dose of 160 mg/d for at least 3 weeks with adequate compliance.
  • Concomitant standing or prn medications (except other antipsychotics and those noted as contraindicated in the ziprasidone package insert) are permitted during all treatment phases if they were present at a stable dose for at least 6 weeks prior to the start of initial ziprasidone treatment.
  • A score of 4 (moderate) or greater on any of the 7 items of the PANSS Positive Symptom Subscale.
  • Clinical judgment by the investigator that doses higher than 160 mg/day are warranted due to suboptimal clinical outcome despite adequate treatment at that dose
  • Patient is judged capable of understanding all relevant risks and potential benefits of the study and has signed informed consent.
  • Comorbid axis 1 conditions (including anxiety disorders, eating disorders, impulse control disorders) are permitted if they have been stable and have not been a primary focus of treatment over the previous 6 months.

Exclusion Criteria:

  • Past or current intolerance of ziprasidone side effects.
  • Presence of significant cardiac disease, including uncompensated congestive heart failure, myocardial infarction within the past 6 months or known history of congenital long QT syndrome.
  • QTc greater than or equal to 500 msec.
  • Serum potassium and magnesium concentrations outside of normal limits.
  • Currently taking any medications which may affect cardiac conduction.
  • Presence of any unstable or untreated medical disorder. Any history of seizures or seizure disorder other than febrile seizures of childhood; history of positive hepatitis B surface antigen; any subject who is HIV + or has diagnosis of AIDS. Any abnormal laboratory test that is judged to be clinically significant by the investigator.
  • History of NMS), hypersensitivity or allergic response to antipsychotic therapy, including ziprasidone
  • History of clozapine treatment for refractory psychotic symptoms
  • Alcohol or substance dependence within the past 12 months or abuse within the past 3 months. Any subject with positive urine toxicology or alcohol use that is considered abnormal at baseline.
  • Clinically significant suicidal or homicidal behavior or attempts within past 6 months.
  • Any subject judged by the investigator to present a danger to self or others.
  • Women of childbearing potential who are not using adequate contraception (oral contraceptives, barrier methods or who are clearly abstinent).
  • Pregnancy or breast-feeding.
  • Any subject who is judged by the investigator to be unable or unlikely to comply with all study requirements, including adherence with prescribed medication regimen.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00403546

Contacts
Contact: Lisa Raeke, M.A.     617-912-7840     lraeke@partners.org    
Contact: Jared Walsh, B.A.     617-912-7864     jpwalsh@partners.org    

Locations
United States, Georgia
Medical College of Georgia     Recruiting
      Augusta, Georgia, United States, 30912
      Contact: Edna Stirewalt     706-721-7968     estirewalt@mcg.edu    
      Contact: Rebecca Blizard     706-721-4605     RBLIZARD@mail.mcg.edu    
      Principal Investigator: Peter Buckley, M.D.            
United States, Massachusetts
Corrigan Mental Health Center     Recruiting
      Fall River, Massachusetts, United States, 02720
      Contact: Meredith Hanrahan-Boshes     508-235-7351     meredith.hanrahan-boshes@dmh.state.ma.us    
      Contact: Amanda Fennessey     508-235-7299     amanda.fennessey@dmh.state.ma.us    
      Principal Investigator: Theo Manschreck, M.D.            
      Sub-Investigator: Roger Boshes, M.D.            
United States, New Mexico
University of New Mexico     Recruiting
      Albuquerque, New Mexico, United States, 87131
      Contact: Tara Biehl     505-272-9544     TBiehl@salud.unm.edu    
      Principal Investigator: Juan Bustillo, M.D.            
United States, New York
Nathan Kline Institute     Recruiting
      Orangeburg, New York, United States, 10962
      Contact: Daniel Antonius     845-398-6561     antonius@nki.rfmh.org    
      Principal Investigator: Leslie Citrome, M.D.            
The Lieber Center for Schizophrenia Research - Columbia University     Recruiting
      New York, New York, United States, 10032
      Contact: Beatriz Alvarez     212-543-5418     Alvarez@pi.cpmc.columbia.edu    
      Contact: Christine Woenne     212-543-5173     Woennec@pi.cpmc.columbia.edu    
      Principal Investigator: Roberto Gil, M.D.            
United States, North Carolina
Duke University - John Umstead Hospital     Recruiting
      Butner, North Carolina, United States, 27509
      Contact: Mike Musty     919-575-7162     mdm22@duke.edu    
      Principal Investigator: Joseph McEvoy, M.D.            
      Sub-Investigator: William Wilson, Ph.D.            
United States, Texas
The Mech Center     Recruiting
      Plano, Texas, United States, 75024
      Contact: Lauren Braunfeld     972-265-3127 ext 150     lauren.braunfeld@themechcenter.com    
      Principal Investigator: Arnold Mech, M.D.            

Sponsors and Collaborators
Massachusetts General Hospital
Pfizer

Investigators
Principal Investigator:     Donald Goff, M.D.     Massachusetts General Hospital    
  More Information


Responsible Party:   Massachusetts General Hospital ( Donald Goff, MD )
Study ID Numbers:   2005-P-001372
First Received:   November 21, 2006
Last Updated:   December 18, 2007
ClinicalTrials.gov Identifier:   NCT00403546
Health Authority:   United States: Food and Drug Administration;   United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Schizophrenia  

Study placed in the following topic categories:
Schizophrenia
Dopamine
Mental Disorders
Psychotic Disorders
Ziprasidone
Serotonin
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:
Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Dopamine Antagonists
Antipsychotic Agents
Pharmacologic Actions
Serotonin Antagonists
Serotonin Agents
Therapeutic Uses
Dopamine Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on October 03, 2008




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