SchizophreniaNCT00538642
Improving Diabetes Risk Factors in Persons With Schizophrenia or Bipolar Disorder by Switching to Ziprasidone
A study testing ziprasidone in people with Schizophrenia and Schizoaffective Disorder, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder, Bipolar Disorder
- What is being tested?
- ziprasidone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to Nov 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center At San Antonio
San Antonio, Texas, 78229
About this study
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
- Being tested
- ziprasidone
- Keywords
- schizophrenia, antipsychotics, diabetes, bipolar disorder
- Medical subject headings
- Schizophrenia, Psychotic Disorders, Bipolar Disorder, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ziprasidoneDrug
Also called Geodon
Patients assigned to ziprasidone arm are cross-titrated from current antipsychotic
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: ziprasidone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin Sensitivity
Euglycemic clamp method
Measured: Baseline
Insulin Sensitivity
Euglycemic clamp method
Measured: 4-5 months
Secondary outcomes (16)
Body Mass Index
Measured: Baseline
Body Mass Index
Measured: 4-5 months
Abdominal Circumference
Measured: Baseline
Abdominal Circumference
Measured: 4-5 months
Systolic Blood Pressure
Measured: Baseline
Systolic Blood Pressure
Measured: 4-5 months
Diastolic Blood Pressure
Measured: Baseline
Diastolic Blood Pressure
Measured: 4-5 months
Triglycerides
Measured: Baseline
Triglycerides
Measured: 4-5 months
Cholesterol
Measured: Baseline
Cholesterol
Measured: 4-5 months
HDL Cholesterol
Measured: Baseline
HDL Cholesterol
Measured: 4-5 months
LDL Cholesterol
Measured: Baseline
LDL Cholesterol
Measured: 4-5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2007 (estimated)
- Study startAug 2007
- Primary completionApr 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexander L. Miller, The University of Texas Health Science Center at San Antonio
- Investigators
- ALEXANDER L MILLER, MD, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00538642
- Sponsor's protocol ID
- 000000010002968
- Other IDs
- 124932
- Status last verified
- Nov 2012
- First submitted
- 2 Oct 2007
- Last updated
- 29 Nov 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Diabetes Risk Factors in Persons With Schizophrenia or Bipolar Disorder by Switching to Ziprasidone
- ClinicalTrials.gov ID
- NCT00538642
- Acronym / sponsor ID
- 000000010002968
- Conditions
- Schizophrenia, Schizoaffective Disorder, Bipolar Disorder
- Keywords
- schizophrenia, antipsychotics, diabetes, bipolar disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Study start
- Aug 2007
- Primary completion
- Apr 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 3 Oct 2007 (estimated)
- Results
- Posted 19 Nov 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Drug: ziprasidoneSubjects switch to daily oral ziprasidone from current antipsychotic(s). Dose titrated to clinically effective level. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ziprasidoneAlso: GeodonPatients assigned to ziprasidone arm are cross-titrated from current antipsychotic | Drug | ziprasidone treatment |
Primary outcome
Insulin Sensitivity
Time frame: Baseline
Euglycemic clamp method
Insulin Sensitivity
Time frame: 4-5 months
Euglycemic clamp method
16 secondary outcomes
Body Mass Index
Time frame: Baseline
Body Mass Index
Time frame: 4-5 months
Abdominal Circumference
Time frame: Baseline
Abdominal Circumference
Time frame: 4-5 months
Systolic Blood Pressure
Time frame: Baseline
Systolic Blood Pressure
Time frame: 4-5 months
Diastolic Blood Pressure
Time frame: Baseline
Diastolic Blood Pressure
Time frame: 4-5 months
Triglycerides
Time frame: Baseline
Triglycerides
Time frame: 4-5 months
Cholesterol
Time frame: Baseline
Cholesterol
Time frame: 4-5 months
HDL Cholesterol
Time frame: Baseline
HDL Cholesterol
Time frame: 4-5 months
LDL Cholesterol
Time frame: Baseline
LDL Cholesterol
Time frame: 4-5 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ALEXANDER L MILLER, MD principal investigator
The University of Texas Health Science Center at San Antonio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ziprasidone in people with Schizophrenia and Schizoaffective Disorder, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Nov 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insulin Sensitivity (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2012; AzTrials last refreshed its copy on 6 Nov 2026.