SchizophreniaNCT01686815
Cross-Sectional Iloperidone IVGTT
An observational study of Schizophrenia and Serious Mental Illness, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
This study aims to utilize state of the art procedures such as the frequently sampled intravenous glucose tolerance test (FSIVGTT), Bergman's Minimal Model Analysis, lipoprotein analysis, and DEXA scans to demonstrate that a newer agent, iloperidone, is devoid of the metabolic abnormalities associated with other… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia, Serious Mental Illness, Metabolic Syndrome
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to May 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Subjects will include 60 outpatients between the ages of 18-65 with schizophrenia, schizoaffective disorder, bipolar disorder, major depressive disorder, psychosis NOS, delusional disorder or paranoid disorder. 60 subjects will be screened and 45 will enter the cross-sectional study (15 olanzapine, 15 iloperidone, 15 risperidone-treated subjects matched for BMI).
Who may be able to join
- Male/Female ages 18-65 years
- Capacity to provide informed consent
- BMI between 20 and 30 kg/m²
- Diagnosis of a serious mental illness, including schizophrenia, any subtype; schizoaffective disorder, any subtype; major depressive disorder, bipolar disorder, psychosis NOS, delusional disorder and paranoid disorder
- Treatment with iloperidone, risperidone, or olanzapine for at least 6 months
- Stable dose of antipsychotic agent for at least one month
- Well established compliance with out-patient medications and clinically stable
- Female subjects will be eligible to participate in the study if they are of non-childbearing potential or of child-bearing potential and willing to practice appropriate birth control methods (complete abstinence from sexual intercourse, female sterilization, sterilization of male partner, implants of levonorgestrel, injectable progestogen, oral contraceptives, intrauterine devices, or double barrier methods of contraception using spermicide with either a condom or diaphragm) during the study.
Who cannot join
- Inability to provide informed consent
- Current substance abuse
- Psychiatrically unstable and/or hospitalized in the past month
- History of significant and untreated medical illness including severe cardiovascular, hepatic, renal, or untreated thyroid disease; hepatitis; or HIV
- Current insulin treatment for diabetes
- Currently taking the following medications: birth control pills containing norgestrol, steroids, thiazide diuretics, or treatment with agents that induce weight loss
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- Intentions of donating blood during or within 30 days of completion of the study.
- Use of valproate or carbamazepine within four weeks of the study
- History of immunosuppression
- Current or recent radiation or chemotherapy treatment for cancer
- Pregnancy or breastfeeding
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Cross-sectional Study to Compare Glucose and Lipid Metabolism in SMI Subjects Treated With Either Fanapt (Iloperidone), Zyprexa (Olanzapine), or Risperdal (Risperidone)
This study aims to utilize state of the art procedures such as the frequently sampled intravenous glucose tolerance test (FSIVGTT), Bergman's Minimal Model Analysis, lipoprotein analysis, and DEXA scans to demonstrate that a newer agent, iloperidone, is devoid of the metabolic abnormalities associated with other atypical antipsychotic treatments, namely olanzapine and risperidone, and offers an advantage over these other agents.
Read the detailed description
This one-month research study examines how Fanapt® (iloperidone), Zyprexa® (olanzapine), or Risperdal® (risperidone) affect glucose metabolism in patients with schizophrenia, schizoaffective disorder, bipolar disorder, major depressive disorder, psychosis NOS, delusional disorder or paranoid disorder. This study requires 3 research visits and includes a physical exam, medical history, vitals, an EKG, cognitive testing, psychological rating scales, a DEXA scan, a nutritional assessment, a 3-hour intravenous glucose tolerance test (IVGTT) and a fasting blood draw.
- Conditions
- Schizophrenia, Serious Mental Illness, Metabolic Syndrome, Insulin Resistance, Glucose Metabolism
- Keywords
- metabolic side effects, atypical antipsychotics, FSIVGTT
- Medical subject headings
- Schizophrenia, Metabolic Syndrome, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Olanzapine | Olanzapine-treated patients with serious mental illness, such as schizophrenia, schizoaffective disorder, bipolar disorder, major depressive disorder, psychosis NOS, delusional disorder or paranoid disorder. | |
| Risperidone | Risperidone-treated patients with serious mental illness, such as schizophrenia, schizoaffective disorder, bipolar disorder, major depressive disorder, psychosis NOS, delusional disorder or paranoid disorder. | |
| Iloperidone | Iloperidone-treated patients with serious mental illness, such as schizophrenia, schizoaffective disorder, bipolar disorder, major depressive disorder, psychosis NOS, delusional disorder or paranoid disorder. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between cohorts in glucose metabolism
Difference between olanzapine- or risperidone-treated subjects, and Iloperidone-treated subjects on glucose metabolism as measured by the FSIVGTT procedure at one time point (Baseline).
Measured: Baseline
Difference between cohorts in triglycerides
Difference between olanzapine- or risperidone-subjects and subjects treated with iloperidone in triglyceride levels measured at one time point (Baseline).
Measured: Baseline
Difference between cohorts on LDL cholesterol
Difference between olanzapine- or risperidone-subjects and subjects treated with iloperidone in LDL cholesterol levels measured at one time point (Baseline).
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2012 (estimated)
- Study startOct 2012
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Responsible party
- Principal investigator, Maurizio Fava, MD, Massachusetts General Hospital
- Investigators
- Maurizio Fava, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01686815
- Sponsor's protocol ID
- CILO522DUSXXT
- Status last verified
- Mar 2019
- First submitted
- 13 Sep 2012
- Last updated
- 12 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-sectional Study to Compare Glucose and Lipid Metabolism in SMI Subjects Treated With Either Fanapt (Iloperidone), Zyprexa (Olanzapine), or Risperdal (Risperidone)
- ClinicalTrials.gov ID
- NCT01686815
- Acronym / sponsor ID
- CILO522DUSXXT
- Conditions
- Schizophrenia, Serious Mental Illness, Metabolic Syndrome, Insulin Resistance, Glucose Metabolism
- Keywords
- metabolic side effects, atypical antipsychotics, FSIVGTT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Study start
- Oct 2012
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 18 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to utilize state of the art procedures such as the frequently sampled intravenous glucose tolerance test (FSIVGTT), Bergman's Minimal Model Analysis, lipoprotein analysis, and DEXA scans to demonstrate that a newer agent, iloperidone, is devoid of the metabolic abnormalities associated with other atypical antipsychotic treatments, namely olanzapine and risperidone, and offers an advantage over these other agents.
Detailed description
This one-month research study examines how Fanapt® (iloperidone), Zyprexa® (olanzapine), or Risperdal® (risperidone) affect glucose metabolism in patients with schizophrenia, schizoaffective disorder, bipolar disorder, major depressive disorder, psychosis NOS, delusional disorder or paranoid disorder. This study requires 3 research visits and includes a physical exam, medical history, vitals, an EKG, cognitive testing, psychological rating scales, a DEXA scan, a nutritional assessment, a 3-hour intravenous glucose tolerance test (IVGTT) and a fasting blood draw.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Olanzapine | – | –Olanzapine-treated patients with serious mental illness, such as schizophrenia, schizoaffective disorder, bipolar disorder, major depressive disorder, psychosis NOS, delusional disorder or paranoid disorder. |
| Risperidone | – | –Risperidone-treated patients with serious mental illness, such as schizophrenia, schizoaffective disorder, bipolar disorder, major depressive disorder, psychosis NOS, delusional disorder or paranoid disorder. |
| Iloperidone | – | –Iloperidone-treated patients with serious mental illness, such as schizophrenia, schizoaffective disorder, bipolar disorder, major depressive disorder, psychosis NOS, delusional disorder or paranoid disorder. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will include 60 outpatients between the ages of 18-65 with schizophrenia, schizoaffective disorder, bipolar disorder, major depressive disorder, psychosis NOS, delusional disorder or paranoid disorder. 60 subjects will be screened and 45 will enter the cross-sectional study (15 olanzapine, 15 iloperidone, 15 risperidone-treated subjects matched for BMI).
Key inclusion criteria (8 listed)
- Male/Female ages 18-65 years
- Capacity to provide informed consent
- BMI between 20 and 30 kg/m²
- Diagnosis of a serious mental illness, including schizophrenia, any subtype; schizoaffective disorder, any subtype; major depressive disorder, bipolar disorder, psychosis NOS, delusional disorder and paranoid disorder
- Treatment with iloperidone, risperidone, or olanzapine for at least 6 months
Key exclusion criteria (11 listed)
- Inability to provide informed consent
- Current substance abuse
- Psychiatrically unstable and/or hospitalized in the past month
- History of significant and untreated medical illness including severe cardiovascular, hepatic, renal, or untreated thyroid disease; hepatitis; or HIV
- Current insulin treatment for diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Difference between cohorts in glucose metabolism
Time frame: Baseline
Difference between olanzapine- or risperidone-treated subjects, and Iloperidone-treated subjects on glucose metabolism as measured by the FSIVGTT procedure at one time point (Baseline).
Difference between cohorts in triglycerides
Time frame: Baseline
Difference between olanzapine- or risperidone-subjects and subjects treated with iloperidone in triglyceride levels measured at one time point (Baseline).
Difference between cohorts on LDL cholesterol
Time frame: Baseline
Difference between olanzapine- or risperidone-subjects and subjects treated with iloperidone in LDL cholesterol levels measured at one time point (Baseline).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2019.
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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.
Maurizio Fava, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia and Serious Mental Illness, run by Massachusetts General Hospital 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 8 inclusion and 11 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 12 Mar 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Difference between cohorts in glucose metabolism (time frame: Baseline). The study lists 3 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 12 Mar 2019.