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

NCT ID: NCT00538642

Last Updated: 2012-11-29

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2011-11-30

Brief Summary

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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

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Conditions

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Schizophrenia Schizoaffective Disorder Bipolar Disorder

Keywords

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schizophrenia antipsychotics diabetes bipolar disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Stay on current antipsychotic

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

Group Type NO_INTERVENTION

No interventions assigned to this group

ziprasidone treatment

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

Group Type ACTIVE_COMPARATOR

ziprasidone

Intervention Type DRUG

Patients assigned to ziprasidone arm are cross-titrated from current antipsychotic

Interventions

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ziprasidone

Patients assigned to ziprasidone arm are cross-titrated from current antipsychotic

Intervention Type DRUG

Other Intervention Names

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Geodon

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The University of Texas Health Science Center at San Antonio

OTHER

Sponsor Role lead

Responsible Party

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Alexander L. Miller

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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ALEXANDER L MILLER, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center at San Antonio

Locations

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The University of Texas Health Science Center At San Antonio

San Antonio, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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124932

Identifier Type: -

Identifier Source: secondary_id

000000010002968

Identifier Type: -

Identifier Source: org_study_id