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

• ClinicalTrials.gov Identifier: NCT00538642
• Recruitment Status: Completed
• First Posted: October 3, 2007
• Results First Posted: November 19, 2012
• Last Update Posted: November 29, 2012
• Sponsor: The University of Texas Health Science Center at San Antonio
• Information provided by (Responsible Party): Alexander L. Miller, The University of Texas Health Science Center at San Antonio

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.

Condition or disease	Intervention/treatment	Phase
Schizophrenia; Schizoaffective Disorder; Bipolar Disorder	Drug: ziprasidone	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Improving Diabetes Risk Factors in Persons With Schizophrenia or Bipolar Disorder by Switching to Ziprasidone
• Study Start Date: August 2007
• Actual Primary Completion Date: April 2011
• Actual Study Completion Date: November 2011

Arms and Interventions

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 Name: Geodon

Outcome Measures

Primary Outcome Measures :

1. Insulin Sensitivity [ Time Frame: Baseline ]
   Euglycemic clamp method
2. Insulin Sensitivity [ Time Frame: 4-5 months ]
   Euglycemic clamp method

Secondary Outcome Measures :

1. Body Mass Index [ Time Frame: Baseline ]
2. Body Mass Index [ Time Frame: 4-5 months ]
3. Abdominal Circumference [ Time Frame: Baseline ]
4. Abdominal Circumference [ Time Frame: 4-5 months ]
5. Systolic Blood Pressure [ Time Frame: Baseline ]
6. Systolic Blood Pressure [ Time Frame: 4-5 months ]
7. Diastolic Blood Pressure [ Time Frame: Baseline ]
8. Diastolic Blood Pressure [ Time Frame: 4-5 months ]
9. Triglycerides [ Time Frame: Baseline ]
10. Triglycerides [ Time Frame: 4-5 months ]
11. Cholesterol [ Time Frame: Baseline ]
12. Cholesterol [ Time Frame: 4-5 months ]
13. HDL Cholesterol [ Time Frame: Baseline ]
14. HDL Cholesterol [ Time Frame: 4-5 months ]
15. LDL Cholesterol [ Time Frame: Baseline ]
16. LDL Cholesterol [ Time Frame: 4-5 months ]

Eligibility Criteria

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

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

Contacts and Locations

Locations

United States, Texas

The University of Texas Health Science Center At San Antonio

San Antonio, Texas, United States, 78229

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: Alexander L. Miller, Principal Investigator, The University of Texas Health Science Center at San Antonio
• ClinicalTrials.gov Identifier: NCT00538642
• Other Study ID Numbers: 000000010002968; 124932
• First Posted: October 3, 2007
• Results First Posted: November 19, 2012
• Last Update Posted: November 29, 2012
• Last Verified: November 2012

Keywords provided by Alexander L. Miller, The University of Texas Health Science Center at San Antonio:

schizophrenia; antipsychotics; diabetes; bipolar disorder

Additional relevant MeSH terms:

Disease; Schizophrenia; Bipolar Disorder; Psychotic Disorders; Pathologic Processes; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Bipolar and Related Disorders; Ziprasidone; Serotonin Antagonists; Serotonin Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Physiological Effects of Drugs; Antipsychotic Agents; Tranquilizing Agents; Central Nervous System Depressants; Psychotropic Drugs; Dopamine Antagonists; Dopamine Agents