Clinical trial NCT00538642: 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
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Schizoaffective Disorder
Bipolar Disorder
Keywords: schizophrenia
antipsychotics
diabetes
bipolar disorder
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
First posted: 2007-10-03
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Insulin Sensitivity
timeFrame: Baseline
measure: Insulin Sensitivity
timeFrame: 4-5 months
Secondary outcomes:
measure: Body Mass Index
timeFrame: Baseline
measure: Body Mass Index
timeFrame: 4-5 months
measure: Abdominal Circumference
timeFrame: Baseline
measure: Abdominal Circumference
timeFrame: 4-5 months
measure: Systolic Blood Pressure
timeFrame: Baseline
measure: Systolic Blood Pressure
timeFrame: 4-5 months
measure: Diastolic Blood Pressure
timeFrame: Baseline
measure: Diastolic Blood Pressure
timeFrame: 4-5 months
measure: Triglycerides
timeFrame: Baseline
measure: Triglycerides
timeFrame: 4-5 months
measure: Cholesterol
timeFrame: Baseline
measure: Cholesterol
timeFrame: 4-5 months
measure: HDL Cholesterol
timeFrame: Baseline
measure: HDL Cholesterol
timeFrame: 4-5 months
measure: LDL Cholesterol
timeFrame: Baseline
measure: LDL Cholesterol
timeFrame: 4-5 months
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: The University of Texas Health Science Center At San Antonio
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center at San Antonio
name: ALEXANDER L MILLER, MD
role: PRINCIPAL_INVESTIGATOR
References: