About Bolder Science

Our mission is to provide healthcare professionals with unbiased clinical research information, easily.

Currently, you can access the following clinical trials being conducted worldwide:

359,057 studies
in
219 countries
Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/21/2021.
This website is for US healthcare professionals

Log In to Bolder Science

or

Don't have an account? Sign Up

Please enter your email address.

You will receive a link to create a new password via email.

Log In

Create an Account

or
(optional) ?

Welcome, !

Please complete the following 4 questions to ensure you receive the information that best suits your needs.

Clinical Trials of Interest

When I’m looking for information on clinical trials, I usually am interested in...

finding clinical trials in which to enroll my patients

Rarely Often

finding newly launched clinical trials (for all phases)

Rarely Often

updates on status changes for clinical trials

Rarely Often

pipeline molecules

Rarely Often

Drug Interventions

Enter up to 3 drug interventions you are currently interested in:

Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/21/2021.

Effects of Intranasal Insulin on Neuroimaging Markers and Cognition in Patients With Psychotic Disorders

Clinicaltrials.gov identifier NCT03943537

Recruitment Status Recruiting

First Posted May 9, 2019

Last update posted December 19, 2019

Study Description

Brief summary:

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.

  • Condition or Disease:Psychosis
    Schizophrenia
    Schizo Affective Disorder
    Bipolar I Disorder
  • Intervention/Treatment: Drug: Intranasal Insulin
  • Phase: Phase 2
Detailed Description

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.

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 40 participants
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Basic Science
  • Official Title: Effects of Intranasal Insulin on Neuroimaging Markers and Cognition in Patients With Psychotic Disorders
  • Actual Study Start Date: October 2019
  • Estimated Primary Completion Date: December 2020
  • Estimated Study Completion Date: December 2020
Arms and interventions
Arm Intervention/treatment
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.
Outcome Measures
  • Primary Outcome Measures: 1. Changes in brain redox state [ Time Frame: 6 hours, pre- and post- 40 IU intranasal insulin ]
    Changes in brain NAD+/NADH ratio as measured by in vivo 31P magnetic resonance spectroscopy
  • 2. Changes in brain ATP [ Time Frame: 6 hours, pre- and post- 40 IU intranasal insulin ]
    Changes in ATP concentration as measured by in vivo 31P magnetic resonance spectroscopy
  • 3. Changes in brain PCr [ Time Frame: 6 hours, pre- and post- 40 IU intranasal insulin ]
    Changes in Phosphocreatine (PCr) concentration as measured by in vivo 31P magnetic resonance spectroscopy
  • 4. Changes in brain CK [ Time Frame: 6 hours, pre- and post- 40 IU intranasal insulin ]
    Changes in creatine kinase (CK) enzyme rate as measured by in vivo 31P magnetic resonance spectroscopy
  • 5. Changes in cognitive function [ Time Frame: 6 hours, pre- and post- 40 IU intranasal insulin ]
    Changes in STROOP assessment color-word condition interference score. This score is calculated as follows, with C being the number of items answered correctly in the color condition, W being the number answered correctly in the word condition, and CW being the number of items answered correctly in the color-word condition: CW - (C x W)/(C+W). Higher scores indicate better cognitive function.
  • 6. Changes in domain-specific cognitive function. [ Time Frame: 6 hours, pre- and post- 40 IU intranasal insulin ]
    Changes in BACS domain subscale scores (domain, range): working memory, 0-36; attention, 0-110; and verbal fluency, number of words generated over 60-sec trials. Higher scores indicate better cognitive function.
  • Secondary Outcome Measures: 1. Changes in brain pH. [ Time Frame: 6 hours, pre- and post- 40 IU intranasal insulin ]
    Changes in pH as measured by in vivo 31P magnetic resonance spectroscopy
  • 2. Changes in brain inorganic phosphate concentration. [ Time Frame: 6 hours, pre- and post- 40 IU intranasal insulin ]
    Changes in inorganic phosphate (Pi) concentration as measured by in vivo 31P magnetic resonance spectroscopy
  • 3. Change in fasting blood glucose levels. [ Time Frame: 6 hours, pre- and post- 40 IU intranasal insulin ]
    Safety outcome.
  • Other Outcome Measures: 1. Changes in brain Gln, Glu and GSH [ Time Frame: 6 hours, pre- and post- 40 IU intranasal insulin ]
    Changes in glutamine (Gln), glutamate (Glu), and glutathione (GSH) concentration as measured by in vivo 31P magnetic resonance spectroscopy
Eligibility Criteria
  • Ages Eligible for Study: 18 to 40 Years (Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: Yes
Criteria

Inclusion Criteria:

- 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
first-degree relatives)

Exclusion Criteria:

- 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
NRTI's.

- 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

Contacts and Locations
Contacts

Contact: Margaret Gardner 617-855-2489 mgardner@mclean.harvard.edu

Contact: Dost Ongur 617-855-3922 DONGUR@PARTNERS.ORG

Locations

United States, Massachusetts
McLean Hospital
Belmont

Sponsors and Collaborators

Mclean Hospital

More Information
  • Responsible Party: Mclean Hospital
  • ClinicalTrials.gov Identifier: NCT03943537 History of Changes
  • Other Study ID Numbers: 2019P000664
  • First Posted: May 9, 2019 Key Record Dates
  • Last Update Posted: December 19, 2019
  • Last Verified: December 2019
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Product Manufactured in and Exported from the U.S.: Yes
  • Keywords provided by Mclean Hospital: Psychosis
    Cognition
    Brain Metabolism
    Insulin
  • Additional relevant MeSH terms: Mental Disorders
    Mood Disorders
    Disease
    Schizophrenia
    Psychotic Disorders