CClinicalTrials.gg
Sign In
CompletedNCT00538642Updated Nov 29, 2012Results posted

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

An interventional study of ziprasidone in Schizophrenia, Schizoaffective Disorder and Bipolar Disorder, sponsored by The University of Texas Health Science Center at San Antonio. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-11-29.

Sponsored by The University of Texas Health Science Center at San Antonio · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Schizophrenia
  • Schizoaffective Disorder
  • Bipolar Disorder

Keywords

  • schizophrenia
  • antipsychotics
  • diabetes
  • bipolar disorder
03

In context

Schizophrenia

3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.

This study's enrollment of 24 is below the median of 70 across 2,872 interventional studies indexed under Schizophrenia.

Browse Schizophrenia studies →

Lead sponsor

The University of Texas Health Science Center at San Antonio is the lead sponsor of 435 studies on the registry; 88 are open to participants now.

Of its 62 completed or terminated interventional studies of FDA-regulated products, 31 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
24 participants (actual)

Study arms

  • 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

Interventions

  • Drugziprasidone

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

    Also known as: Geodon

06

What researchers measure

Primary outcomes

  1. Insulin Sensitivity

    Euglycemic clamp method

    Time frame: Baseline

  2. Insulin Sensitivity

    Euglycemic clamp method

    Time frame: 4-5 months

Secondary outcomes

  1. Body Mass Index

    Time frame: Baseline

  2. Body Mass Index

    Time frame: 4-5 months

  3. Abdominal Circumference

    Time frame: Baseline

  4. Abdominal Circumference

    Time frame: 4-5 months

  5. Systolic Blood Pressure

    Time frame: Baseline

  6. Systolic Blood Pressure

    Time frame: 4-5 months

  7. Diastolic Blood Pressure

    Time frame: Baseline

  8. Diastolic Blood Pressure

    Time frame: 4-5 months

  9. Triglycerides

    Time frame: Baseline

  10. Triglycerides

    Time frame: 4-5 months

  11. Cholesterol

    Time frame: Baseline

  12. Cholesterol

    Time frame: 4-5 months

  13. HDL Cholesterol

    Time frame: Baseline

  14. HDL Cholesterol

    Time frame: 4-5 months

  15. LDL Cholesterol

    Time frame: Baseline

  16. LDL Cholesterol

    Time frame: 4-5 months

07

Results

Posted Nov 19, 2012

Participant flow

Participant flow — Overall Study
MilestoneStay on Current AntipsychoticZiprasidone Treatment
Started1014
Completed99
Not completed15

Outcome measures

PrimaryInsulin Sensitivity

Euglycemic clamp method

Time frame:
Baseline
Reported as:
Mean · mg glucose/kg.min/μIU insulin
Insulin Sensitivity
mg glucose/kg.min/μIU insulinStay on Current AntipsychoticZiprasidone Treatment
Insulin Sensitivity5.55 ± 3.511.88 ± 1.08
Statistical analysis
  • Stay on Current Antipsychotic vs Ziprasidone Treatment · ANOVA · p = <0.05
SecondaryBody Mass Index
Time frame:
Baseline
Reported as:
Mean · Kg/m2
Body Mass Index
Kg/m2Stay on Current AntipsychoticZiprasidone Treatment
Body Mass Index38.4 ± 10.539.0 ± 4.1
SecondaryBody Mass Index
Time frame:
4-5 months
Reported as:
Mean · Kg/m2
Body Mass Index
Kg/m2Stay on Current AntipsychoticZiprasidone Treatment
Body Mass Index36.0 ± 6.438.8 ± 4.2
SecondaryAbdominal Circumference
Time frame:
Baseline
Reported as:
Mean · cm
Abdominal Circumference
cmStay on Current AntipsychoticZiprasidone Treatment
Abdominal Circumference115 ± 20126 ± 17
SecondaryAbdominal Circumference
Time frame:
4-5 months
Reported as:
Mean · cm
Abdominal Circumference
cmStay on Current AntipsychoticZiprasidone Treatment
Abdominal Circumference115 ± 19122 ± 8
SecondarySystolic Blood Pressure
Time frame:
Baseline
Reported as:
Mean · mm Hg
Systolic Blood Pressure
mm HgStay on Current AntipsychoticZiprasidone Treatment
Systolic Blood Pressure118 ± 15121 ± 13
SecondarySystolic Blood Pressure
Time frame:
4-5 months
Reported as:
Mean · mm Hg
Systolic Blood Pressure
mm HgStay on Current AntipsychoticZiprasidone Treatment
Systolic Blood Pressure123 ± 15128 ± 15
SecondaryDiastolic Blood Pressure
Time frame:
Baseline
Reported as:
Mean · mm Hg
Diastolic Blood Pressure
mm HgStay on Current AntipsychoticZiprasidone Treatment
Diastolic Blood Pressure81 ± 1080 ± 9
SecondaryDiastolic Blood Pressure
Time frame:
4-5 months
Reported as:
Mean · mm Hg
Diastolic Blood Pressure
mm HgStay on Current AntipsychoticZiprasidone Treatment
Diastolic Blood Pressure82 ± 981 ± 13
SecondaryTriglycerides
Time frame:
Baseline
Reported as:
Mean · mg/dL
Triglycerides
mg/dLStay on Current AntipsychoticZiprasidone Treatment
Triglycerides183 ± 166227 ± 154
SecondaryTriglycerides
Time frame:
4-5 months
Reported as:
Mean · mg/dL
Triglycerides
mg/dLStay on Current AntipsychoticZiprasidone Treatment
Triglycerides154 ± 87252 ± 179
SecondaryCholesterol
Time frame:
Baseline
Reported as:
Mean · mg/dL
Cholesterol
mg/dLStay on Current AntipsychoticZiprasidone Treatment
Cholesterol176 ± 53176 ± 36
SecondaryCholesterol
Time frame:
4-5 months
Reported as:
Mean · mg/dL
Cholesterol
mg/dLStay on Current AntipsychoticZiprasidone Treatment
Cholesterol177 ± 34186 ± 44
SecondaryHDL Cholesterol
Time frame:
Baseline
Reported as:
Mean · mg/dL
HDL Cholesterol
mg/dLStay on Current AntipsychoticZiprasidone Treatment
HDL Cholesterol34 ± 835 ± 5
SecondaryHDL Cholesterol
Time frame:
4-5 months
Reported as:
Mean · mg/dL
HDL Cholesterol
mg/dLStay on Current AntipsychoticZiprasidone Treatment
HDL Cholesterol40 ± 938 ± 9
SecondaryLDL Cholesterol
Time frame:
Baseline
Reported as:
Mean · mg/dL
LDL Cholesterol
mg/dLStay on Current AntipsychoticZiprasidone Treatment
LDL Cholesterol108 ± 43106 ± 35
SecondaryLDL Cholesterol
Time frame:
4-5 months
Reported as:
Mean · mg/dL
LDL Cholesterol
mg/dLStay on Current AntipsychoticZiprasidone Treatment
LDL Cholesterol106 ± 29109 ± 35
PrimaryInsulin Sensitivity

Euglycemic clamp method

Time frame:
4-5 months
Reported as:
Mean · mg glucose/kg.min/μIU insulin
Insulin Sensitivity
mg glucose/kg.min/μIU insulinStay on Current AntipsychoticZiprasidone Treatment
Insulin Sensitivity6.01 ± 3.932.07 ± 1.15

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Stay on Current Antipsychotic—0/10 (0%)0/10 (0%)
Ziprasidone Treatment—0/14 (0%)0/14 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Stay on Current AntipsychoticZiprasidone TreatmentTotal
<=18 years000
Between 18 and 65 years101424
>=65 years000
Age Continuous
Age Continuous(years)Stay on Current AntipsychoticZiprasidone TreatmentTotal
Mean38.6 ± 9.0541.43 ± 8.4640.25 ± 8.63
Sex: Female, Male
Sex: Female, Male(Participants)Stay on Current AntipsychoticZiprasidone TreatmentTotal
Female6814
Male4610
Region of Enrollment
Region of Enrollment(participants)Stay on Current AntipsychoticZiprasidone TreatmentTotal
United States101424
08

Study locations

1 site
  • The University of Texas Health Science Center At San Antonio
    San Antonio, Texas 78229, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 29, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00538642
Lead sponsor
The University of Texas Health Science Center at San Antonio
Responsible party
Alexander L. Miller (Principal Investigator, The University of Texas Health Science Center at San Antonio) — Principal investigator
First posted
Oct 3, 2007
Start date
Aug 2007
Primary completion
Apr 2011
Completion
Nov 2011
Results posted
Nov 19, 2012
Last update
Nov 29, 2012

Study contacts

ALEXANDER L MILLER, MD
principal investigator · The University of Texas Health Science Center at San Antonio

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2012. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Schizophrenia→

Other studies from this sponsor

The University of Texas Health Science Center at San Antonio

Start the discussion