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Ziprasidone for Clozapine- or Olanzapine-Associated Diabetes Mellitus

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ClinicalTrials.gov Identifier: NCT00351000
Recruitment Status : Completed
First Posted : July 12, 2006
Results First Posted : January 28, 2013
Last Update Posted : January 13, 2017
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
David C. Henderson, MD, Harvard Medical School

Study Description
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Brief Summary:
This study is a six-week, open label trial of the novel antipsychotic agent, ziprasidone, added to a stable dose of clozapine or olanzapine in 40 diabetes mellitus patients, patients with an impaired fasting glucose or insulin resistance with schizophrenia or schizoaffective disorder. The first two weeks will be a fixed-dose of ziprasidone 40 mg twice a day. During weeks 2-6, the ziprasidone dose may be increased up to 80 mg twice a day.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Ziprasidone Phase 4

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label Trial of Ziprasidone as an Adjuvant for Clozapine- or Olanzapine-Associated Diabetes Mellitus or Impaired Fasting Glucose in Chronic Schizophrenia
Study Start Date : January 2005
Actual Study Completion Date : March 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Change From Baseline in Fasting Glucose [ Time Frame: baseline, week 6 ]
    Subjects on clozapine with adjunctive ziprasidone were compared to subjects on olanzapine with adjunctive ziprasidone on change in fasting glucose levels from baseline to study endpoint (week 6 - baseline)

  2. Change From Baseline on Fasting Insulin [ Time Frame: baseline, week 6 ]
    Subjects on clozapine with adjunctive ziprasidone were compared to subjects on olanzapine with adjunctive ziprasidone on change in fasting insulin levels from baseline to study endpoint (week 6 - baseline)


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Diagnosis of Schizophrenia, any subtype or schizoaffective disorder
  • Ages 18-65 years
  • Capable of providing informed consent
  • Antipsychotic Agents -associated diabetes mellitus, impaired fasting glucose or insulin resistance
  • Stable dose of clozapine or olanzapine for at least 1 month
  • Optimal dose of clozapine or olanzapine, or a maximal dose if limited by significant side effects

Exclusion Criteria:

  • Serious medical or neurological illness (unstable cardiac disease including recent myocardial infarction or heart failure, seizure disorder, malignancy, liver or renal impairment, etc.)
  • Current substance abuse
  • Pregnancy, nursing, or unwilling to use appropriate birth control measures during participation if female and fertile
  • History of serious blood dyscrasia requiring discontinuation of clozapine
  • Serious suicidal or homicidal risk within the past six months
  • History of diabetes mellitus prior to treatment with clozapine or olanzapine
  • H/o prolongation of QTc interval (>450) on EKG or clinically significant EKG abnormalities.
  • Treatment with medications that significantly prolong QTc interval such as dofetilde, sotalol, quinidine, class Ia and III antiarrhythmics, mesoridazine, thioridazine, chlorpromazine, droperidol, pimozide, sparfloxacin, gatifloxacin, moxifloxacine, halofantrine, mefloquine, pentamidine, arsenic trioxide, levomethadyul acetate, dolasetron myselate, probucol, or tacrolimus.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00351000


Locations
United States, Massachusetts
Freedom Trail Clinic
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
North Suffolk Mental Health Association
Pfizer
Investigators
Principal Investigator: David C Henderson, MD North Suffolk Mental Health Association
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

Responsible Party: David C. Henderson, MD, Associate Professor of Psychiatry, Harvard Medical School
ClinicalTrials.gov Identifier: NCT00351000     History of Changes
Other Study ID Numbers: 1-2005
First Posted: July 12, 2006    Key Record Dates
Results First Posted: January 28, 2013
Last Update Posted: January 13, 2017
Last Verified: November 2016

Keywords provided by David C. Henderson, MD, Harvard Medical School:
Schizophrenia
Ziprasidone
Diabetes
Insulin Resistance

Additional relevant MeSH terms:
Diabetes Mellitus
Schizophrenia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Olanzapine
Ziprasidone
Clozapine
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
 Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Serotonin Antagonists
Dopamine Antagonists
Dopamine Agents
GABA Antagonists
GABA Agents