Improving Diabetes Risk Factors in Persons With Schizophrenia by Switching to Ziprasidone

This study is currently recruiting participants.

Verified by The University of Texas Health Science Center at San Antonio, December 2008

Sponsored by:	The University of Texas Health Science Center at San Antonio
Information provided by:	The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier:	NCT00538642

Purpose

Having a diagnosis of schizophrenia and being treated with certain of the newer antipsychotics are risk factors for development of diabetes. Subjects with these risk factors plus obesity and/or family history of diabetes who agree to study participation will undergo an oral glucose tolerance test. If the oral glucose tolerance test demonstrates that the subject is pre-diabetic (elevated glucose levels, but below the diabetic range), he/she will have his/her insulin resistance level measured, prior to random assignment to either stay on current antipsychotic medication or switch to ziprasidone. Insulin resistance will be measured again after four months. The primary hypothesis is that insulin resistance will decrease in those switched to ziprasidone relative to those continuing on their same antipsychotic medication.

Condition	Intervention
Schizophrenia Schizoaffective Disorder	Drug: ziprasidone

MedlinePlus related topics: Diabetes Schizophrenia

Drug Information available for: Ziprasidone Ziprasidone hydrochloride Ziprasidone mesylate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Improving Diabetes Risk Factors in Persons With Schizophrenia by Switching to Ziprasidone

Further study details as provided by The University of Texas Health Science Center at San Antonio:

Primary Outcome Measures:

Insulin resistance [ Time Frame: Four months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

(1) BMI and abdominal circumference, (2) blood triglycerides (TG), (3) HDL, (4) the TG/HDL ratio, and (5) blood pressure [ Time Frame: Four months ] [ Designated as safety issue: No ]

Estimated Enrollment:	36
Study Start Date:	August 2007
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Stay: No Intervention Subjects stay on same antipsychotic treatment as at baseline.
Switch: Active Comparator Subjects switch to ziprasidone	Drug: ziprasidone

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosis of schizophrenia or schizoaffective disorder (not bipolar type)
BMI>29.9 or family history of diabetes and/or abdominal circumference greater than 88 cm in women or 102 cm in men
Pre-diabetic oral glucose tolerance test
Current treatment with olanzapine, risperidone, paliperidone, or quetiapine, or combination of these
Willing to switch to ziprasidone
No psychiatric hospitalizations in past three months and judged by treating clinician to be suitable for antipsychotic medication switch
Able to give informed consent to study

Exclusion Criteria:

Judged to be currently suicidal, homicidal, or unable to cooperate with treatment
Unstable serious medical illness
Current use of drugs that interfere with glucose and fat metabolism (sulfonylureas, metformin, TZDs). The use of "statins" and fibrates will be allowed ONLY if stable dose for past 3 months.
Current diagnosis of diabetes
Fasting blood glucose >125 mg/dl

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00538642

Contacts

Contact: DESIREE CASTILLO, BS

210-567-0781

CASTILLOD@UTHSCSA.EDU

Locations

United States, Texas
the University of Texas Health Science Center at San Antonio	Recruiting
SAN ANTONIO, Texas, United States, 78229
Sub-Investigator: ALBANA DASSORI, MD
Sub-Investigator: EUGENIO CERSOSIMO, MD
Sub-Investigator: ANTONIO CERVERA-CETINA, MD
Sub-Investigator: CHRISTOPHER WALLACE, MD

Sponsors and Collaborators

The University of Texas Health Science Center at San Antonio

Investigators

Principal Investigator:

ALEXANDER L MILLER, MD

The University of Texas Health Science Center at San Antonio

More Information

Responsible Party:	The University of Texas Health Science Center at San Antonio ( Alexander Miller, M.D. )
Study ID Numbers:	000000010002968, 124932
Study First Received:	October 2, 2007
Last Updated:	December 12, 2008
ClinicalTrials.gov Identifier:	NCT00538642
Health Authority:	United States: Institutional Review Board

Keywords provided by The University of Texas Health Science Center at San Antonio:

schizophrenia
antipsychotics
diabetes
hispanic

Study placed in the following topic categories:

Schizophrenia
Dopamine
Mental Disorders
Diabetes Mellitus

Psychotic Disorders
Ziprasidone
Serotonin
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Dopamine Antagonists

Antipsychotic Agents
Pharmacologic Actions
Serotonin Antagonists
Serotonin Agents
Therapeutic Uses
Dopamine Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009