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)
NCT number | NCT01686815 |
Other study ID # | CILO522DUSXXT |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | October 2012 |
Est. completion date | May 2016 |
Verified date | March 2019 |
Source | Massachusetts General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Massachusetts General Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Massachusetts General Hospital | Novartis Pharmaceuticals |
United States,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05039489 -
A Study on the Brain Mechanism of cTBS in Improving Medication-resistant Auditory Hallucinations in Schizophrenia
|
N/A | |
Completed |
NCT05321602 -
Study to Evaluate the PK Profiles of LY03010 in Patients With Schizophrenia or Schizoaffective Disorder
|
Phase 1 | |
Completed |
NCT05111548 -
Brain Stimulation and Cognitive Training - Efficacy
|
N/A | |
Completed |
NCT04503954 -
Efficacy of Chronic Disease Self-management Program in People With Schizophrenia
|
N/A | |
Completed |
NCT02831231 -
Pilot Study Comparing Effects of Xanomeline Alone to Xanomeline Plus Trospium
|
Phase 1 | |
Completed |
NCT05517460 -
The Efficacy of Auricular Acupressure on Improving Constipation Among Residents in Community Rehabilitation Center
|
N/A | |
Completed |
NCT03652974 -
Disturbance of Plasma Cytokine Parameters in Clozapine-Resistant Treatment-Refractory Schizophrenia (CTRS) and Their Association With Combination Therapy
|
Phase 4 | |
Recruiting |
NCT04012684 -
rTMS on Mismatch Negativity of Schizophrenia
|
N/A | |
Recruiting |
NCT04481217 -
Cognitive Factors Mediating the Relationship Between Childhood Trauma and Auditory Hallucinations in Schizophrenia
|
N/A | |
Completed |
NCT00212784 -
Efficacy and Safety of Asenapine Using an Active Control in Subjects With Schizophrenia or Schizoaffective Disorder (25517)(P05935)
|
Phase 3 | |
Completed |
NCT04092686 -
A Clinical Trial That Will Study the Efficacy and Safety of an Investigational Drug in Acutely Psychotic People With Schizophrenia
|
Phase 3 | |
Completed |
NCT01914393 -
Pediatric Open-Label Extension Study
|
Phase 3 | |
Recruiting |
NCT03790345 -
Vitamin B6 and B12 in the Treatment of Movement Disorders Induced by Antipsychotics
|
Phase 2/Phase 3 | |
Recruiting |
NCT05956327 -
Insight Into Hippocampal Neuroplasticity in Schizophrenia by Investigating Molecular Pathways During Physical Training
|
N/A | |
Terminated |
NCT03261817 -
A Controlled Study With Remote Web-based Adapted Physical Activity (e-APA) in Psychotic Disorders
|
N/A | |
Terminated |
NCT03209778 -
Involuntary Memories Investigation in Schizophrenia
|
N/A | |
Completed |
NCT02905604 -
Magnetic Stimulation of the Brain in Schizophrenia or Depression
|
N/A | |
Recruiting |
NCT05542212 -
Intra-cortical Inhibition and Cognitive Deficits in Schizophrenia
|
N/A | |
Completed |
NCT04411979 -
Effects of 12 Weeks Walking on Cognitive Function in Schizophrenia
|
N/A | |
Terminated |
NCT03220438 -
TMS Enhancement of Visual Plasticity in Schizophrenia
|
N/A |