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Currently, you can access the following clinical trials being conducted worldwide:
Clinicaltrials.gov identifier NCT03943537
Recruitment Status Recruiting
First Posted May 9, 2019
Last update posted December 19, 2019
This clinical trial is a single center, single dose study of the acute effects of intranasal insulin on energy metabolism and cognitive function in patients with schizophrenia, schizoaffective and bipolar disorders, compared and healthy controls.
Psychotic disorders are common and severe psychiatric disorders. Despite advances in understanding the pathophysiology of these disorders, more effective and tolerable treatments are still needed. Evidence suggests that energy metabolism is altered in psychotic disorders. The investigators recently developed non-invasive MRI-based techniques to quantify redox balance and ATP generation in the brain. Targeting insulin pathways in the brain may allow for modulating abnormalities in energy metabolism. The investigators seek to examine whether intranasal insulin can modulate energy metabolism and improve cognition in patients with psychotic disorders. The study will use magnetic resonance spectroscopy (MRS) technology to measure in vivo energy metabolism processes in the brain, before and after the administration of intranasal insulin. Investigators will also measure changes in cognition with the administration of intranasal insulin.
|Experimental: Intranasal Insulin (40 IU)
40 IU Novolin-R insulin will be administered one time using the ViaNase intranasal delivery device.
Drug: Intranasal Insulin
40 units Novolin R administered intranasally using ViaNase device.
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, , Learn About Clinical Studies.-->
- Diagnostic and Statistical Manual of Mental Disorders (DSM) diagnoses of
schizophrenia, schizoaffective disorder or bipolar disorder with psychotic features OR
- Healthy Controls (no history of DSM psychiatric diagnoses, nor history of the same in
- Psychiatric hospitalization within the last 4 weeks
- Unstable/active disease or potential contraindications, such as liver disease, kidney
disease, uncontrolled hypertension, significant or unstable medical illness
- Currently prescribed: antidiabetic agents, including oral antidiabetic medications and
insulin, intranasal medication, steroids, weight loss agents, protease inhibitors, or
- Pregnant or breast-feeding, not using an effective form of contraception for at least
3 months, and/or not abstinent for 1 month prior to enrollment
- History of significant head injury
- Contraindication to MRI scans (claustrophobia, cardiac pacemakers, metal clips and
stents on blood vessels, artificial heart valves, artificial arms, hands, legs, etc.,
brain stimulator devices, implanted drug pumps, ear implants, eye implants or known
metal fragments in eyes, exposure to shrapnel or metal filings, other metallic
surgical hardware in vital areas, certain tattoos with metallic ink, certain
transdermal patches, metal-containing IUDs).
- Medical conditions preventing blood draws
- History of electroconvulsive therapy (ECT) within the last 6 months
- BMI > 35 or body weight > 350 lbs
- DSM diagnosis of substance use disorder in the past 6 months
- For Healthy Controls:
- Taking medication other than birth control
Contact: Margaret Gardner 617-855-2489 email@example.com
Contact: Dost Ongur 617-855-3922 DONGUR@PARTNERS.ORG
United States, Massachusetts