Ziprasidone for Clozapine- or Olanzapine-Associated Diabetes Mellitus
This study has been completed.
Sponsor:
North Suffolk Mental Health Association
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
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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:
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
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: NCT00351000
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 Endocrine System Diseases Glucose Metabolism Disorders Mental Disorders Metabolic Diseases Schizophrenia and Disorders with Psychotic Features Ziprasidone Antipsychotic Agents Central Nervous System Agents Central Nervous System Depressants |
Dopamine Agents Dopamine Antagonists Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Pharmacologic Actions Physiological Effects of Drugs Psychotropic Drugs Serotonin Agents Serotonin Antagonists Therapeutic Uses Tranquilizing Agents |
ClinicalTrials.gov processed this record on March 01, 2015