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Cross-Sectional Iloperidone IVGTT

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ClinicalTrials.gov Identifier: NCT01686815
Recruitment Status : Completed
First Posted : September 18, 2012
Last Update Posted : March 12, 2019
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Maurizio Fava, MD, Massachusetts General Hospital

Brief 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 atypical antipsychotic treatments, namely olanzapine and risperidone, and offers an advantage over these other agents.

Condition or disease
Schizophrenia Serious Mental Illness Metabolic Syndrome Insulin Resistance Glucose Metabolism

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.

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Study Type : Observational
Actual Enrollment : 37 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Cross-sectional Study to Compare Glucose and Lipid Metabolism in SMI Subjects Treated With Either Fanapt (Iloperidone), Zyprexa (Olanzapine), or Risperdal (Risperidone)
Study Start Date : October 2012
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine


Group/Cohort
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.



Primary Outcome Measures :
  1. 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).

  2. 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).

  3. 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).


Biospecimen Retention:   Samples Without DNA
Samples will be retained to test IL-6 and other inflammatory markers.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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).
Criteria

Inclusion Criteria:

  1. Male/Female ages 18-65 years
  2. Capacity to provide informed consent
  3. BMI between 20 and 30 kg/m²
  4. 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
  5. Treatment with iloperidone, risperidone, or olanzapine for at least 6 months
  6. Stable dose of antipsychotic agent for at least one month
  7. Well established compliance with out-patient medications and clinically stable
  8. 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:

  1. Inability to provide informed consent
  2. Current substance abuse
  3. Psychiatrically unstable and/or hospitalized in the past month
  4. History of significant and untreated medical illness including severe cardiovascular, hepatic, renal, or untreated thyroid disease; hepatitis; or HIV
  5. Current insulin treatment for diabetes
  6. Currently taking the following medications: birth control pills containing norgestrol, steroids, thiazide diuretics, or treatment with agents that induce weight loss
  7. Intentions of donating blood during or within 30 days of completion of the study.
  8. Use of valproate or carbamazepine within four weeks of the study
  9. History of immunosuppression
  10. Current or recent radiation or chemotherapy treatment for cancer
  11. Pregnancy or breastfeeding

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01686815


Locations
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Novartis Pharmaceuticals
Investigators
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Principal Investigator: Maurizio Fava, MD Massachusetts General Hospital

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Responsible Party: Maurizio Fava, MD, Vice Chair, Psychiatry, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01686815     History of Changes
Other Study ID Numbers: CILO522DUSXXT
First Posted: September 18, 2012    Key Record Dates
Last Update Posted: March 12, 2019
Last Verified: March 2019

Keywords provided by Maurizio Fava, MD, Massachusetts General Hospital:
metabolic side effects
atypical antipsychotics
FSIVGTT

Additional relevant MeSH terms:
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Metabolic Syndrome
Insulin Resistance
Schizophrenia
Mental Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Olanzapine
Risperidone
Iloperidone
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators