CompletedPhase 2

Semaglutide for the Treatment of Cognitive Dysfunction in Major Depressive Disorder

Canada72 participantsStarted 2021-10-06

Plain-language summary

This study will examine whether semaglutide may improve cognitive function in individuals with major depressive disorder (MDD).

Who can participate

Age range

18 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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)

Exclusion criteria

. 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
. Severe mood episode, defined as a Hamilton Depression Rating Scale (HAMD-17) score of \>23
. Actively suicidal or evaluated as being a suicide risk (operationalized as a score of ≥3 on HAMD-17 suicide item and/or by clinical assessment).
. Substance use disorder within 3 months before screening or a positive baseline toxicology screen

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Executive Function Composite Score

Timeframe: 16 Weeks

Trial details

NCT IDNCT04466345

SponsorUniversity Health Network, Toronto

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-27

View on ClinicalTrials.gov More Major Depressive Disorder trials