Ziprasidone for Clozapine- or Olanzapine-Associated Diabetes Mellitus
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00351000 |
Recruitment Status :
Completed
First Posted : July 12, 2006
Results First Posted : January 28, 2013
Last Update Posted : January 13, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Schizophrenia | Drug: Ziprasidone | Phase 4 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 24 participants |
Allocation: | N/A |
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 |

- 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)
- 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)

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.

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
United States, Massachusetts | |
Freedom Trail Clinic | |
Boston, Massachusetts, United States, 02114 |
Principal Investigator: | David C Henderson, MD | North Suffolk Mental Health Association |
Responsible Party: | David C. Henderson, MD, Associate Professor of Psychiatry, Harvard Medical School |
ClinicalTrials.gov Identifier: | NCT00351000 |
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 |
Schizophrenia Ziprasidone Diabetes Insulin Resistance |
Diabetes Mellitus Schizophrenia Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Schizophrenia Spectrum and Other Psychotic Disorders Mental Disorders Ziprasidone Serotonin Antagonists Serotonin Agents |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Dopamine Antagonists Dopamine Agents |