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Brain Insulin Resistance in Mood Disorders

NCT03915613 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2023-12-15

No results posted yet for this study

Summary

The overarching aim of the study is to determine the role of insulin signaling on the neurobiological substrates subserving anhedonia within individuals with mood disorders (i.e., Bipolar Disorder (BD) and Major Depressive Disorder (MDD)).

Specific aims include:

1. Molecular: Assessment of components of the insulin cascade, as well as of anhedonia and reward-related processes, using a proteomics and gene expression approach;
2. Physiology: Measurement of peripheral sensitivity to insulin and metabolic correlates, including body mass index and dyslipidemia;
3. Neural Circuits: Evaluation of the insulin sensitivity of prefrontal (e.g. prefrontal cortex) and striatal (e.g. nucleus accumbens, ventral tegmental area) networks in the resting-state and during an effort-based decision making test, using acutely administered intranasal insulin and functional magnetic resonance imaging (fMRI);
4. Behavioral: Measurement of willingness to make effort for rewards, as well as of other components of reward response and anhedonia, using validated behavioral tasks and clinical scales (e.g. Snaith-Hamilton Pleasure Scale - SHPS).

This initiative represents a proof-of-concept study that insulin is important to anhedonia, neurocognitive functioning, and behavioural deficits in MDD, representing a novel and safe therapeutic avenue.

Conditions

Interventions

DRUG

Humulin R

The investigator and/or designee will instruct the study participant on how the intranasal insulin spray should be administered. Each study participant is to receive a single dose of Humulin R 160 U. The nasal spray bottles provide a deliverable volume of 0.1 mL/spray. Humulin R insulin will be sourced as 100 units/mL in a vials of 10 mL from Eli Lilly. 16 sprays in alternating nostrils (8 per nostril) will be administered per dose.

DRUG

Diluent

The investigator and/or designee will instruct the study participant on how the intranasal placebo spray should be administered. Each study participant is to receive a single dose of placebo. The nasal spray bottles provide a deliverable volume of 0.1 mL/spray. Diluent will be sourced as 10 mL/vial from Eli Lilly. 16 sprays in alternating nostrils (8 per nostril) will be administered per dose.

Sponsors & Collaborators

  • University Health Network, Toronto

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-10-06
Primary Completion
2024-10-05
Completion
2024-10-05

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03915613 on ClinicalTrials.gov