Ziprasidone for Clozapine- or Olanzapine-Associated Diabetes Mellitus - Full Text View

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:

Genetics Home Reference related topics: schizophrenia

MedlinePlus related topics: Schizophrenia

Drug Information available for: Clozapine Ziprasidone hydrochloride Olanzapine Ziprasidone Ziprasidone mesylate

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 (Adult)
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

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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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 Spectrum and Other Psychotic Disorders Mental Disorders Olanzapine Clozapine Ziprasidone 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 GABA Antagonists GABA Agents Dopamine Antagonists Dopamine Agents

ClinicalTrials.gov processed this record on September 27, 2016