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

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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia; Schizoaffective Disorder; Bipolar Disorder
• Intervention / Treatment: Drug: ziprasidone

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78229
      • The University of Texas Health Science Center at San Antonio

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Stay on current antipsychotic; Subjects stay on same daily oral antipsychotic treatment as at baseline. Dose adjustments allowable as clinically indicated.
Active Comparator: ziprasidone treatment; Subjects switch to daily oral ziprasidone from current antipsychotic(s). Dose titrated to clinically effective level.	Drug: ziprasidone; Patients assigned to ziprasidone arm are cross-titrated from current antipsychotic; Other Names: Geodon

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insulin Sensitivity	Euglycemic clamp method	Baseline
Insulin Sensitivity	Euglycemic clamp method	4-5 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Systolic Blood Pressure	Baseline
Diastolic Blood Pressure	Baseline
LDL Cholesterol	Baseline
HDL Cholesterol	Baseline
Body Mass Index	Baseline
Triglycerides	Baseline
Body Mass Index	4-5 months
Abdominal Circumference	Baseline
Abdominal Circumference	4-5 months
Systolic Blood Pressure	4-5 months
Diastolic Blood Pressure	4-5 months
Triglycerides	4-5 months
Cholesterol	Baseline
Cholesterol	4-5 months
HDL Cholesterol	4-5 months
LDL Cholesterol	4-5 months

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start: August 1, 2007
• Primary Completion (Actual): April 1, 2011
• Study Completion (Actual): November 1, 2011

Study Registration Dates

• First Submitted: October 2, 2007
• First Submitted That Met QC Criteria: October 2, 2007
• First Posted (Estimate): October 3, 2007

Study Record Updates

• Last Update Posted (Estimate): November 29, 2012
• Last Update Submitted That Met QC Criteria: November 27, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Keywords: diabetes; schizophrenia; bipolar disorder; antipsychotics
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Schizophrenia Spectrum and Other Psychotic Disorders; Bipolar and Related Disorders; Schizophrenia; Disease; Psychotic Disorders; Bipolar Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Dopamine Agents; Serotonin Antagonists; Dopamine Antagonists; Ziprasidone
• Other Study ID Numbers: 000000010002968; 124932