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

Not Applicable

Completed

• Conditions: Schizophrenia; Schizoaffective Disorder; Bipolar Disorder
• Interventions: Drug: ziprasidone

• Registration Number: NCT00538642
• Lead Sponsor: The University of Texas Health Science Center at San Antonio

Brief Summary

Having a diagnosis of schizophrenia or bipolar disorder 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08
• Study First Submitted: 2007-10-02
• Study First Submitted QC: 2007-10-02
• Study First Posted: 2007-10-03
• Primary Completion: 2011-04
• Study Completion: 2011-11
• Results First Submitted: 2012-09-13
• Results First Submitted QC: 2012-10-18
• Status Verified: 2012-11
• Results First Posted: 2012-11-19
• Last Update Submitted: 2012-11-27
• Last Update Posted: 2012-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Diagnosis of schizophrenia or schizoaffective disorder or bipolar disorder
• 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

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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, thiazolidinediones). 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ziprasidone treatment	ziprasidone	Subjects switch to daily oral ziprasidone from current antipsychotic(s). Dose titrated to clinically effective level.

Primary Outcome Measures

Name	Time	Method
Insulin Sensitivity	4-5 months	Euglycemic clamp method

Secondary Outcome Measures

Name	Time	Method
Triglycerides	4-5 months
Cholesterol	4-5 months
HDL Cholesterol	4-5 months
LDL Cholesterol	4-5 months
Body Mass Index	4-5 months
Abdominal Circumference	4-5 months
Systolic Blood Pressure	4-5 months
Diastolic Blood Pressure	4-5 months

Trial Locations

Locations (1)

The University of Texas Health Science Center At San Antonio; 🇺🇸 San Antonio, Texas, United States