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

NCT00538642 | Completed Results DMC

• 2 other identifiers: 000000010002968124932
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia; Schizoaffective Disorder; Bipolar Disorder

Keywords

schizophrenia; antipsychotics; diabetes; bipolar disorder

Outcome Measures

Primary Outcomes (2)

• Insulin Sensitivity

  Euglycemic clamp method

  Baseline

• Insulin Sensitivity

  Euglycemic clamp method

  4-5 months

Secondary Outcomes (16)

• Body Mass Index

  Baseline

• Body Mass Index

  4-5 months

• Abdominal Circumference

  Baseline

• Abdominal Circumference

  4-5 months

• Systolic Blood Pressure

  Baseline

Study Arms (2)

Stay on current antipsychotic

NO INTERVENTION

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

ziprasidone treatment

ACTIVE COMPARATOR

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

Drug: ziprasidone

Interventions

ziprasidone DRUG

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

Also known as: Geodon

ziprasidone treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead

Study Sites (1)

The University of Texas Health Science Center At San Antonio

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders; Bipolar Disorder; Diabetes Mellitus

Interventions

ziprasidone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Bipolar and Related Disorders; Mood Disorders; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Dr. Alexander Miller
• Organization: University of Texas Health Science Center at San Antonio

millera@uthscsa.edu

210-567-5508

Study Officials

• ALEXANDER L MILLER, MD

  The University of Texas Health Science Center at San Antonio

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 2, 2007
• First Posted: October 3, 2007
• Study Start: August 1, 2007
• Primary Completion: April 1, 2011
• Study Completion: November 1, 2011
• Last Updated: November 29, 2012
• Results First Posted: November 19, 2012

Record last verified: 2012-11

Locations

US (1)