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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alexander L. Miller, The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier:
NCT00538642
First received: October 2, 2007
Last updated: November 27, 2012
Last verified: November 2012
History of Changes
  Purpose

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 Intervention
Schizophrenia
Schizoaffective Disorder
Bipolar Disorder
 Drug: ziprasidone

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Improving Diabetes Risk Factors in Persons With Schizophrenia or Bipolar Disorder by Switching to Ziprasidone

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Insulin Sensitivity [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Euglycemic clamp method

  • Insulin Sensitivity [ Time Frame: 4-5 months ] [ Designated as safety issue: No ]
    Euglycemic clamp method


Secondary Outcome Measures:
  • Body Mass Index [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Body Mass Index [ Time Frame: 4-5 months ] [ Designated as safety issue: No ]
  • Abdominal Circumference [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Abdominal Circumference [ Time Frame: 4-5 months ] [ Designated as safety issue: No ]
  • Systolic Blood Pressure [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Systolic Blood Pressure [ Time Frame: 4-5 months ] [ Designated as safety issue: No ]
  • Diastolic Blood Pressure [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Diastolic Blood Pressure [ Time Frame: 4-5 months ] [ Designated as safety issue: No ]
  • Triglycerides [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Triglycerides [ Time Frame: 4-5 months ] [ Designated as safety issue: No ]
  • Cholesterol [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Cholesterol [ Time Frame: 4-5 months ] [ Designated as safety issue: No ]
  • HDL Cholesterol [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • HDL Cholesterol [ Time Frame: 4-5 months ] [ Designated as safety issue: No ]
  • LDL Cholesterol [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • LDL Cholesterol [ Time Frame: 4-5 months ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: August 2007
Study Completion Date: November 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

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

No publications provided

Responsible Party: Alexander L. Miller, Principal Investigator, The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT00538642     History of Changes
Other Study ID Numbers: 000000010002968, 124932
Study First Received: October 2, 2007
Results First Received: September 13, 2012
Last Updated: November 27, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by The University of Texas Health Science Center at San Antonio:
schizophrenia
antipsychotics
diabetes
bipolar disorder

Additional relevant MeSH terms:
Bipolar Disorder
Psychotic Disorders
Schizophrenia
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
Antipsychotic Agents
Ziprasidone
Tranquilizing Agents
Central Nervous System Depressants
 Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on May 16, 2013