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

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by:
Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00403546
First received: November 21, 2006
Last updated: July 5, 2011
Last verified: July 2011
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: High-Dose Oral Ziprasidone Versus Conventional Dosing in Schizophrenia Patients With Residual Symptoms

Resource links provided by NLM:


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
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Geodon
    Geodon 160mg or placebo bid
    Other Name: Ziprasidone
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Georgia
Medical College of Georgia
Augusta, Georgia, United States, 30912
United States, Massachusetts
Corrigan Mental Health Center
Fall River, Massachusetts, United States, 02720
United States, Michigan
Touchstone innovare
Grand Rapids, Michigan, United States, 49503
United States, New Mexico
University of New Mexico
Albuquerque, New Mexico, United States, 87131
United States, New York
SUNY Downstate Medical Center
Brooklyn, New York, United States, 11203
The Lieber Center for Schizophrenia Research - Columbia University
New York, New York, United States, 10032
Nathan Kline Institute
Orangeburg, New York, United States, 10962
United States, North Carolina
Duke University - John Umstead Hospital
Butner, North Carolina, United States, 27509
United States, Texas
The Mech Center
Plano, Texas, United States, 75024
Sponsors and Collaborators
Massachusetts General Hospital
Pfizer
Investigators
Principal Investigator: Donald Goff, M.D. Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Donald Goff, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00403546     History of Changes
Other Study ID Numbers: 2005-P-001372
Study First Received: November 21, 2006
Last Updated: July 5, 2011
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Schizophrenia

Additional relevant MeSH terms:
Schizophrenia
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 July 29, 2014