Semaglutide for the Treatment of Cognitive Dysfunction in Major Depressive Disorder

What Was Tested

This registered phase 2 trial tested Semaglutide.

It had two arms (groups): Semaglutide (experimental) and Placebo (placebo comparator).

Participants receive matching semaglutide placebo capsules once daily (duration of 16 weeks).

The registry classes the interventions as biological.

More on the Plan

This is a 16-week, placebo-controlled, randomized, double-blind, clinical trial, involving 60 overweight individuals with MDD and pre-treatment cognitive dysfunction.

Participants will be assessed to examine the effect of semaglutide on their cognitive function.

Who Took Part

Enrollment: 72 actual participants took part.

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

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Informed consent before study-related activity. Individuals between the ages of 18 and 60 who meet Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria for MDD. Overweight (i.e. BMI ≥ 25 kg/m2). Below-average (i.e. \>1 SD below norm) performance in the Trail Making Test-B (TMTB).

The full record lists 4 inclusion and 12 exclusion criteria; among the exclusions: current, or in the past 4 weeks, treatment with other oral hypoglycemic agents and/or insulin; diagnosis of possible or probable alzheimer's disease, mild cognitive impairment, 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

It was run as a randomized, parallel-group and triple-blind study.

The participants were allocated by chance, so the Semaglutide group and the comparison group should start out alike.

The Semaglutide group and the comparison group ran side by side rather than switching.

Blinding on both sides kept the participants and researchers unaware of who received Semaglutide.

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

It started in 2021-10-06 with completion listed for 2024-12-27.

It ran at 1 site in Canada.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Executive Function Composite Score (time frame: 16 Weeks).

It also tracked 15 secondary outcomes, for example Digit Symbol Substitution Test (DSST), Rey Auditory Verbal Learning Test (RAVLT), Stroop Test, Trail Making Test A (TMTA), Perceived Deficits Questionnaire (PDQ) and Sheehan Disability Scale (SDS).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Semaglutide in 72 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Semaglutide compound page, all human trials.