Cross-Sectional Iloperidone IVGTT

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Massachusetts General Hospital
Sponsor:
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: March 26, 2014
Last verified: March 2014
  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
Serious Mental Illness
Metabolic Syndrome
Insulin Resistance
Glucose Metabolism

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 SMI 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).


Biospecimen Retention:   Samples Without DNA

Samples will be retained to test IL-6 and other inflammatory markers.


Estimated Enrollment: 60
Study Start Date: October 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  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, 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; or 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 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: March 26, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
metabolic side effects
atypical antipsychotics
FSIVGTT

Additional relevant MeSH terms:
Schizophrenia
Metabolic Syndrome X
Insulin Resistance
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
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
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors

ClinicalTrials.gov processed this record on September 18, 2014