Semaglutide for Cognitive Impairment in Depression

Overseen by Rodrigo B. Mansur, MD, PhD

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: University Health Network, Toronto

Prior Safety Data

Approved in 6 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial will test if semaglutide can improve thinking skills in overweight people with depression. Semaglutide is a medication that helps control blood sugar and might also help the brain work better. It is used for weight loss and blood sugar control, and has shown potential benefits for brain function.

Research Team

Rodrigo B. Mansur, MD, PhD

Principal Investigator

University Health Network, Toronto

Eligibility Criteria

This trial is for adults aged 18-60 with major depressive disorder (MDD) who have cognitive issues and are overweight. Participants must perform below average on a specific cognitive test and not be severely depressed, drug-dependent, pregnant, or breastfeeding. They can't have certain mental health conditions or be taking diabetes medications.

Inclusion Criteria

My BMI is 25 or higher, indicating I am overweight.

I am between 18 and 60 years old and have been diagnosed with major depression.

Below-average (i.e. >1 SD below norm) performance in the Trail Making Test-B (TMTB)

Exclusion Criteria

I have used diabetes medication or insulin in the last 4 weeks.

I have a history of neurological disorders or illnesses that could affect my thinking.

I have been diagnosed with Alzheimer's, Mild Cognitive Impairment, or another form of dementia.

Treatment Details

Interventions

• Semaglutide (Glucagon-like peptide-1 receptor agonist)

Trial Overview The study tests if semaglutide improves brain function in people with MDD. It's a comparison between semaglutide and a placebo (a substance with no active drug). Participants will receive either the real medication or placebo without knowing which one they're getting.

Participant Groups

Group I: Semaglutide Experimental Treatment 1 Intervention

Participants receive semaglutide once daily orally, initiated at 3 mg/day for 4 weeks, increased to 7 mg/day for 4 more weeks and titrated to 14 mg/day for the subsequent 8 weeks (i.e., duration of 16 weeks in total).

Group II: Placebo Placebo Group 1 Intervention

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

Semaglutide is already approved in Canada, Japan for the following indications:

Approved in Canada as Ozempic for:

• Type 2 diabetes
• Cardiovascular disease
• Obesity

Approved in Japan as Ozempic for:

• Type 2 diabetes
• Cardiovascular disease
• Obesity

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Dr. Brad Wouters

University Health Network, Toronto

Chief Medical Officer since 2020

MD from University of Toronto

Dr. Kevin Smith

University Health Network, Toronto

Chief Executive Officer since 2018

Professor at McMaster University and University of Toronto