SchizophreniaPhase 4NCT00338949
Ziprasidone for Improving Insulin Sensitivity in People With Schizophrenia Who Are at Risk for Diabetes
A Phase 4 study testing Switch in people with Schizophrenia and Metabolic Syndrome X, run by Veterans Medical Research Foundation at 1 site in United States.
Trial summary
This study will evaluate the effectiveness of ziprasidone treatment versus treatment with a standard atypical antipsychotic drug in improving insulin sensitivity and reducing excess abdominal fat storage in people with schizophrenia who are at risk for diabetes. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia, Metabolic Syndrome X, Insulin Resistance
- What is being tested?
- Switch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2006to Dec 2009
- Phase
- Phase 4
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of schizophrenia or schizoaffective disorder
- Currently receiving antipsychotic therapy with risperidone or olanzapine
- Overweight
Who cannot join
- Diagnosis of diabetes
- Hospitalization for schizophrenia or schizoaffective disorder within 90 days prior to study entry
- Refractory schizophrenia or schizoaffective disorder
- Currently receiving therapy with clozapine
- No stable residence and phone number for 90 days prior to study entry
- Prior unsuccessful treatment with ziprasidone
- Intolerance to ziprasidone
Trial locations and contacts
1 site in 1 country.
United States1 site
VA San Diego Healthcare System
San Diego, California, 92161
About this study
Official title: The Metabolic Syndrome in Patients With Schizophrenia
This study will evaluate the effectiveness of ziprasidone treatment versus treatment with a standard atypical antipsychotic drug in improving insulin sensitivity and reducing excess abdominal fat storage in people with schizophrenia who are at risk for diabetes.
Read the detailed description
People with schizophrenia often lead more sedentary lifestyles than people without the disease, and they are frequently treated with antipsychotic medications that cause weight gain. Combined, these factors produce an increased risk for metabolic syndrome, which can lead to heart disease and type 2 diabetes. Characteristics of metabolic syndrome include carrying excess weight around the abdominal region; high blood pressure; high blood sugar levels; high levels of fat in the blood; and low levels of HDL cholesterol. Recent studies have shown that certain atypical antipsychotic drugs are relatively weight-neutral. Switching from a drug that promotes weight gain to a weight-neutral medication, such as ziprasidone, may result in significant weight loss. There is insufficient evidence, however, demonstrating the extent of improvement in insulin sensitivity after switching medications. This study will evaluate the effectiveness of ziprasidone treatment versus treatment with a standard atypical antipsychotic drug in improving insulin sensitivity and reducing excess abdominal fat storage in people with schizophrenia who are at risk for diabetes.
Participants in this open label study will currently be undergoing treatment with risperidone or olanzapine at the time of study entry. Upon study entry, they will be randomly assigned to either switch to ziprasidone treatment or remain on their current medications. Both groups will be treated for 26 weeks. Participants will report to the study site for evaluations biweekly until week 10 and then monthly for the duration of the study. The primary outcomes at Week 26 will be: change from baseline in insulin sensitivity, using an intravenous glucose tolerance test; change from baseline in ivisceral fat mass, using a CT scan.
- Conditions
- Schizophrenia, Metabolic Syndrome X, Insulin Resistance
- Being tested
- Switch, Control
- Keywords
- Ziprasidone, Olanzapine, Risperidone, Schizoaffective Disorder, Insulin Sensitivity, Visceral Adiposity, Metabolic Syndrome
- Medical subject headings
- Schizophrenia, Metabolic Syndrome, Insulin Resistance, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SwitchDrug
Also called ziprasidone
Participants who are switched to ziprasidone will take a max daily dose of 200 mg, flexibly dosed based on symptoms and adverse effects.
ControlDrug
Also called risperidone, olanzapine
Participants will remain taking the same medications of risperidone or olanzapine as they were before study entry.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Participants on risperidone or olanzapine who will remain on risperidone or olanzapine and do not switch to ziprasidone Receives: Drug: Control |
| Switch | Experimental | Participants who enter on risperidone or olanzapine and switch to ziprasidone Receives: Drug: Switch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Insulin Sensitivity Index From Baseline to Week 26 ((1/mU/L) x 1/Min)
As measured by frequently sampled intravenous glucose tolerance testing (units: 1/mU/L) x 1/Min)
Measured: Measured at Baseline and Week 26
Change in Visceral Fat Mass From Baseline to Week 26
CT measured change in visceral fat mass from baseline to week 26 (mm^3)
Measured: Baseline and Week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2006 (estimated)
- Study startJun 2006
- Primary completionDec 2009
- Study completionDec 2009
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Veterans Medical Research Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Pfizer
- Responsible party
- Principal investigator, Jonathan M. Meyer, MD, Veterans Medical Research Foundation
- Investigators
- Jonathan M. Meyer, MD, Principal investigator, University of California, San Diego & VA San Diego Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00338949
- Sponsor's protocol ID
- K23MH074540
- Other IDs
- K23MH074540, GA128029
- Status last verified
- Oct 2020
- First submitted
- 16 Jun 2006
- Last updated
- 30 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes
Publications
McEvoy JP, Meyer JM, Goff DC, Nasrallah HA, Davis SM, Sullivan L, Meltzer HY, Hsiao J, Scott Stroup T, Lieberman JA. Prevalence of the metabolic syndrome in patients with schizophrenia: baseline results from the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) schizophrenia trial and comparison with national estimates from NHANES III. Schizophr Res. 2005 Dec 1;80(1):19-32. doi: 10.1016/j.schres.2005.07.014. Epub 2005 Aug 30.
PubMed 16137860
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Metabolic Syndrome in Patients With Schizophrenia
- ClinicalTrials.gov ID
- NCT00338949
- Acronym / sponsor ID
- K23MH074540
- Conditions
- Schizophrenia, Metabolic Syndrome X, Insulin Resistance
- Keywords
- Ziprasidone, Olanzapine, Risperidone, Schizoaffective Disorder, Insulin Sensitivity, Visceral Adiposity, Metabolic Syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Veterans Medical Research FoundationUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Pfizer
- Study start
- Jun 2006
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 20 Jun 2006 (estimated)
- Results
- Posted 21 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the effectiveness of ziprasidone treatment versus treatment with a standard atypical antipsychotic drug in improving insulin sensitivity and reducing excess abdominal fat storage in people with schizophrenia who are at risk for diabetes.
Detailed description
People with schizophrenia often lead more sedentary lifestyles than people without the disease, and they are frequently treated with antipsychotic medications that cause weight gain. Combined, these factors produce an increased risk for metabolic syndrome, which can lead to heart disease and type 2 diabetes. Characteristics of metabolic syndrome include carrying excess weight around the abdominal region; high blood pressure; high blood sugar levels; high levels of fat in the blood; and low levels of HDL cholesterol. Recent studies have shown that certain atypical antipsychotic drugs are relatively weight-neutral. Switching from a drug that promotes weight gain to a weight-neutral medication, such as ziprasidone, may result in significant weight loss. There is insufficient evidence, however, demonstrating the extent of improvement in insulin sensitivity after switching medications. This study will evaluate the effectiveness of ziprasidone treatment versus treatment with a standard atypical antipsychotic drug in improving insulin sensitivity and reducing excess abdominal fat storage in people with schizophrenia who are at risk for diabetes.
Participants in this open label study will currently be undergoing treatment with risperidone or olanzapine at the time of study entry. Upon study entry, they will be randomly assigned to either switch to ziprasidone treatment or remain on their current medications. Both groups will be treated for 26 weeks. Participants will report to the study site for evaluations biweekly until week 10 and then monthly for the duration of the study. The primary outcomes at Week 26 will be: change from baseline in insulin sensitivity, using an intravenous glucose tolerance test; change from baseline in ivisceral fat mass, using a CT scan.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Drug: ControlParticipants on risperidone or olanzapine who will remain on risperidone or olanzapine and do not switch to ziprasidone |
| Switch | Experimental | Drug: SwitchParticipants who enter on risperidone or olanzapine and switch to ziprasidone |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of schizophrenia or schizoaffective disorder
- Currently receiving antipsychotic therapy with risperidone or olanzapine
- Overweight
Key exclusion criteria (7 listed)
- Diagnosis of diabetes
- Hospitalization for schizophrenia or schizoaffective disorder within 90 days prior to study entry
- Refractory schizophrenia or schizoaffective disorder
- Currently receiving therapy with clozapine
- No stable residence and phone number for 90 days prior to study entry
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 |
|---|---|---|
| SwitchAlso: ziprasidoneParticipants who are switched to ziprasidone will take a max daily dose of 200 mg, flexibly dosed based on symptoms and adverse effects. | Drug | Switch |
| ControlAlso: risperidone, olanzapineParticipants will remain taking the same medications of risperidone or olanzapine as they were before study entry. | Drug | Control |
Primary outcome
Change in Insulin Sensitivity Index From Baseline to Week 26 ((1/mU/L) x 1/Min)
Time frame: Measured at Baseline and Week 26
As measured by frequently sampled intravenous glucose tolerance testing (units: 1/mU/L) x 1/Min)
Change in Visceral Fat Mass From Baseline to Week 26
Time frame: Baseline and Week 26
CT measured change in visceral fat mass from baseline to week 26 (mm^3)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 16137860McEvoy JP, Meyer JM, Goff DC, Nasrallah HA, Davis SM, Sullivan L, Meltzer HY, Hsiao J, Scott Stroup T, Lieberman JA. Prevalence of the metabolic syndrome in patients with schizophrenia: baseline results from the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) schizophrenia trial and comparison with national estimates from NHANES III. Schizophr Res. 2005 Dec 1;80(1):19-32. doi: 10.1016/j.schres.2005.07.014. Epub 2005 Aug 30.
- Individual participant dataSharing planned: Yes
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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.
Jonathan M. Meyer, MD principal investigator
University of California, San Diego & VA San Diego Healthcare System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Switch in people with Schizophrenia and Metabolic Syndrome X, run by Veterans Medical Research Foundation 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 3 inclusion and 7 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 30 Oct 2020. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Aug 2020). 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?
Change in Insulin Sensitivity Index From Baseline to Week 26 ((1/mU/L) x 1/Min) (time frame: Measured at Baseline and Week 26). 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?
On the ClinicalTrials.gov record for NCT00338949, which also lists 1 linked publication.
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 30 Oct 2020.