Novartis Iloperidone IVGTT
This study is not yet open for participant recruitment.
Verified September 2012 by Massachusetts General Hospital
Sponsor:
David C. Henderson
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
David C. Henderson, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01686815
First received: September 13, 2012
Last updated: NA
Last verified: September 2012
History: No changes posted
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Purpose
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.
| Condition |
|---|
|
Schizophrenia Schizoaffective Disorder |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Cross-Sectional |
| Official Title: | Cross-sectional Study to Compare Glucose and Lipid Metabolism in Schizophrenia Subjects Treated With Either Fanapt (Iloperidone), Zyprexa (Olanzapine), or Risperdal (Risperidone) |
Resource links provided by NLM:
Further study details as provided by Massachusetts General Hospital:
Primary Outcome Measures:
- Difference between cohorts in glucose metabolism [ Time Frame: Baseline ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]Difference between olanzapine- or risperidone-subjects and subjects treated with iloperidone in LDL cholesterol levels measured at one time point (Baseline).
| Estimated Enrollment: | 60 |
| Study Start Date: | October 2012 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Olanzapine
Olanzapine-treated patients with schizophrenia or schizoaffective disorder.
|
|
Risperidone
Risperidone-treated patients with schizophrenia or schizoaffective disorder.
|
|
Iloperidone
Iloperidone-treated patients with schizophrenia or schizoaffective disorder.
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Subjects will include 60 outpatients between the ages of 18-65 with schizophrenia or schizoaffective 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).
Criteria
Inclusion Criteria:
- Male/Female ages 18-65 years
- Capacity to provide informed consent
- BMI between 20 and 30 kg/m²
- Diagnosis of schizophrenia, any subtype or schizoaffective disorder, any subtype
- 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
Exclusion Criteria:
- 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; diabetes mellitus; hepatitis; or HIV
- Current insulin treatment for diabetes
- Currently taking the following medications: birth control pills containing norgestral, steroids, propanolol, and thiazide diuretics Treatment with agents that induce weight loss
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01686815
Contacts
| Contact: Liana J Petruzzi | 617-912-7882 | lpetruzzi@partners.org |
| Contact: Leah N Briggs, BS | 617-912-7848 | lbriggs@partners.org |
Locations
| United States, Massachusetts | |
| Freedom Trail Clinic | Not yet recruiting |
| Boston, Massachusetts, United States, 02114 | |
| Contact: Liana J Petruzzi, BA 617-912-7882 lpetruzzi@partners.org | |
| Contact: Leah N Briggs, BS 617-912-7848 lbriggs@partners.org | |
| Principal Investigator: David C Henderson, MD | |
Sponsors and Collaborators
David C. Henderson
Novartis Pharmaceuticals
Investigators
| Principal Investigator: | David C Henderson, MD | Massachusetts General Hospital |
More Information
No publications provided
| Responsible Party: | David C. Henderson, Associate Professor of Psychiatry, Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT01686815 History of Changes |
| Other Study ID Numbers: | CILO522DUSXXT |
| Study First Received: | September 13, 2012 |
| Last Updated: | September 13, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Massachusetts General Hospital:
|
metabolic side effects atypical antipsychotics FSIVGTT |
Additional relevant MeSH terms:
|
Psychotic Disorders Schizophrenia Schizophrenia and Disorders with Psychotic Features Mental Disorders Risperidone Olanzapine Serotonin Antagonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Antipsychotic Agents |
Tranquilizing Agents Central Nervous System Depressants Central Nervous System Agents Therapeutic Uses Psychotropic Drugs Dopamine Antagonists Dopamine Agents Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Antiemetics Autonomic Agents Peripheral Nervous System Agents Gastrointestinal Agents |
ClinicalTrials.gov processed this record on May 16, 2013