Cross-Sectional Iloperidone IVGTT

Schizophrenia Clinical Trial

Official title:

Cross-sectional Study to Compare Glucose and Lipid Metabolism in SMI Subjects Treated With Either Fanapt (Iloperidone), Zyprexa (Olanzapine), or Risperdal (Risperidone)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01686815
• Other study ID #: CILO522DUSXXT
• Status: Completed
• Start date: October 2012
• Est. completion date: May 2016

Study information

• Verified date: March 2019
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Glucose Metabolism
• Insulin Resistance
• Mental Disorders
• Metabolic Syndrome
• Schizophrenia
• Serious Mental Illness

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Baseline
Primary	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).	Baseline
Primary	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).	Baseline