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

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00538642
• Other study ID #: 000000010002968
• Secondary ID: 124932
• Status: Completed
• Phase: N/A
• First received: October 2, 2007
• Last updated: November 27, 2012
• Start date: August 2007
• Est. completion date: November 2011

Study information

• Verified date: November 2012
• Source: The University of Texas Health Science Center at San Antonio
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: November 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Disorder
• Disease
• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia

Intervention

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

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center At San Antonio	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center at San Antonio

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin Sensitivity	Euglycemic clamp method	Baseline	No
Primary	Insulin Sensitivity	Euglycemic clamp method	4-5 months	No
Secondary	Body Mass Index		Baseline	No
Secondary	Body Mass Index		4-5 months	No
Secondary	Abdominal Circumference		Baseline	No
Secondary	Abdominal Circumference		4-5 months	No
Secondary	Systolic Blood Pressure		Baseline	No
Secondary	Systolic Blood Pressure		4-5 months	No
Secondary	Diastolic Blood Pressure		Baseline	No
Secondary	Diastolic Blood Pressure		4-5 months	No
Secondary	Triglycerides		Baseline	No
Secondary	Triglycerides		4-5 months	No
Secondary	Cholesterol		Baseline	No
Secondary	Cholesterol		4-5 months	No
Secondary	HDL Cholesterol		Baseline	No
Secondary	HDL Cholesterol		4-5 months	No
Secondary	LDL Cholesterol		Baseline	No
Secondary	LDL Cholesterol		4-5 months	No