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Ziprasidone for Clozapine- or Olanzapine-Associated Diabetes Mellitus

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
David C. Henderson, MD, Harvard University
ClinicalTrials.gov Identifier:
NCT00351000
First received: July 11, 2006
Last updated: January 30, 2013
Last verified: January 2013
History of Changes
  Purpose

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 Intervention Phase
Schizophrenia
 Drug: Ziprasidone
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by North Suffolk Mental Health Association:

Primary Outcome Measures:
  • Change From Baseline in Fasting Glucose [ Time Frame: baseline, week 6 ] [ Designated as safety issue: No ]
    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)

  • Change From Baseline on Fasting Insulin [ Time Frame: baseline, week 6 ] [ Designated as safety issue: No ]
    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)


Enrollment: 24
Study Start Date: January 2005
Study Completion Date: March 2007
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

Publications:

Responsible Party: David C. Henderson, MD, Associate Professor of Psychiatry, Harvard University
ClinicalTrials.gov Identifier: NCT00351000     History of Changes
Other Study ID Numbers: 1-2005
Study First Received: July 11, 2006
Results First Received: December 20, 2012
Last Updated: January 30, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by North Suffolk Mental Health Association:
Schizophrenia
Ziprasidone
Diabetes
Insulin Resistance

Additional relevant MeSH terms:
Diabetes Mellitus
Schizophrenia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Clozapine
Ziprasidone
Olanzapine
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
GABA Antagonists
GABA Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on May 16, 2013