search
Back to results

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

Primary Purpose

Schizophrenia, Schizoaffective Disorder, Bipolar Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ziprasidone
Sponsored by
The University of Texas Health Science Center at San Antonio
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring schizophrenia, antipsychotics, diabetes, bipolar disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

Sites / Locations

  • The University of Texas Health Science Center At San Antonio

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Stay on current antipsychotic

ziprasidone treatment

Arm Description

Subjects stay on same daily oral antipsychotic treatment as at baseline. Dose adjustments allowable as clinically indicated.

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

Outcomes

Primary Outcome Measures

Insulin Sensitivity
Euglycemic clamp method
Insulin Sensitivity
Euglycemic clamp method

Secondary Outcome Measures

Body Mass Index
Body Mass Index
Abdominal Circumference
Abdominal Circumference
Systolic Blood Pressure
Systolic Blood Pressure
Diastolic Blood Pressure
Diastolic Blood Pressure
Triglycerides
Triglycerides
Cholesterol
Cholesterol
HDL Cholesterol
HDL Cholesterol
LDL Cholesterol
LDL Cholesterol

Full Information

First Posted
October 2, 2007
Last Updated
November 27, 2012
Sponsor
The University of Texas Health Science Center at San Antonio
search

1. Study Identification

Unique Protocol Identification Number
NCT00538642
Brief Title
Improving Diabetes Risk Factors in Persons With Schizophrenia or Bipolar Disorder by Switching to Ziprasidone
Official Title
Improving Diabetes Risk Factors in Persons With Schizophrenia or Bipolar Disorder by Switching to Ziprasidone
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center at San Antonio

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizoaffective Disorder, Bipolar Disorder
Keywords
schizophrenia, antipsychotics, diabetes, bipolar disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stay on current antipsychotic
Arm Type
No Intervention
Arm Description
Subjects stay on same daily oral antipsychotic treatment as at baseline. Dose adjustments allowable as clinically indicated.
Arm Title
ziprasidone treatment
Arm Type
Active Comparator
Arm Description
Subjects switch to daily oral ziprasidone from current antipsychotic(s). Dose titrated to clinically effective level.
Intervention Type
Drug
Intervention Name(s)
ziprasidone
Other Intervention Name(s)
Geodon
Intervention Description
Patients assigned to ziprasidone arm are cross-titrated from current antipsychotic
Primary Outcome Measure Information:
Title
Insulin Sensitivity
Description
Euglycemic clamp method
Time Frame
Baseline
Title
Insulin Sensitivity
Description
Euglycemic clamp method
Time Frame
4-5 months
Secondary Outcome Measure Information:
Title
Body Mass Index
Time Frame
Baseline
Title
Body Mass Index
Time Frame
4-5 months
Title
Abdominal Circumference
Time Frame
Baseline
Title
Abdominal Circumference
Time Frame
4-5 months
Title
Systolic Blood Pressure
Time Frame
Baseline
Title
Systolic Blood Pressure
Time Frame
4-5 months
Title
Diastolic Blood Pressure
Time Frame
Baseline
Title
Diastolic Blood Pressure
Time Frame
4-5 months
Title
Triglycerides
Time Frame
Baseline
Title
Triglycerides
Time Frame
4-5 months
Title
Cholesterol
Time Frame
Baseline
Title
Cholesterol
Time Frame
4-5 months
Title
HDL Cholesterol
Time Frame
Baseline
Title
HDL Cholesterol
Time Frame
4-5 months
Title
LDL Cholesterol
Time Frame
Baseline
Title
LDL Cholesterol
Time Frame
4-5 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ALEXANDER L MILLER, MD
Organizational Affiliation
The University of Texas Health Science Center at San Antonio
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center At San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs