Cross-Sectional Iloperidone IVGTT

Sponsor

Massachusetts General Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01686815

Collaborator

Novartis Pharmaceuticals (Industry)

Enrollment

Location

Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
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.

Study Design

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 :

Oct 1, 2012

Actual Primary Completion Date :

May 1, 2016

Actual Study Completion Date :

May 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

Difference between cohorts in glucose metabolism [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 [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 [Baseline]
Difference between olanzapine- or risperidone-subjects and subjects treated with iloperidone in LDL cholesterol levels measured at one time point (Baseline).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

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; 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
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