Brain Insulin Resistance in Mood Disorders

What Was Tested

In this phase 1, phase 2 trial, researchers set out to test Insulin (regular human) for insulin resistance, prediabetes & type 2 diabetes.

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)).

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.

It had two arms (groups): Insulin (experimental) and Sterile Diluent (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

Enrollment into the study is voluntary.

Eligible participants will provide written informed consent.

The MDPU case report form will gather information on the participant's course of illness variables.

The ongoing provision of care is not contingent on enrollment and/or completion of the study protocol.

Who Took Part

Enrollment: 150 planned participants were the target.

It was open to people of any sex aged from 18 years up to 60 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: DSM-5 defined MDD/BD and a total score ≥20 on the Montgomery-Åsberg Depression Rating Scale (MADRS) and no history of dementia or intellectual disability. A written, voluntary informed consent prior to study enrollment.

The full record lists 3 inclusion and 15 exclusion criteria; among the exclusions: use of insulin and/or oral hypoglycemiants, due to its confounding effects; diagnosis of possible or probable ad, mci, or any other dementia; history of neurological disorder, or evidence of neurologic or other physical illness that could produce cognitive deterioration.

How the Study Was Run

Design: randomized, crossover and quadruple-blind.

The insulin resistance, prediabetes & type 2 diabetes participants were allocated by chance, so the Insulin (regular human) group and the comparison group should start out alike.

Each person switched between Insulin (regular human) and the comparison at some point, usually with a gap in between.

Blinding on both sides kept the insulin resistance, prediabetes & type 2 diabetes participants and researchers unaware of who received Insulin (regular human).

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2021-10-06 with completion listed for 2024-10-05.

It ran at 1 site in Canada.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Effort-Expenditure for Rewards Task (EEfRT) (time frame: 2 weeks).

It also tracked 12 secondary outcomes, for example Young Mania Rating Scale (YMRS), Montgomery-Asberg Depression Scale (MADRS), Snaith-Hamilton Pleasure Scale (SHAPS), Perceived Deficits Questionnaire-Depression (PDQ-D), Sheehan Disability Scale (SDS) and The DeJong Gierveld Loneliness Scale.

What This Means in Plain Language

Put simply, this is a phase 1, phase 2, randomized trial of Insulin (regular human) in 150 people with insulin resistance, prediabetes & type 2 diabetes.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin (regular human) compound page, Insulin resistance, prediabetes & type 2 diabetes research.