NCT04466345

Semaglutide for the Treatment of Cognitive Dysfunction in Major Depressive Disorder

Adjunctive Semaglutide for the Treatment of Cognitive Dysfunction in Major Depressive Disorder: a Randomized, Double-Blind, Placebo-Controlled Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: University Health Network, Toronto · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

This is a 16-week, placebo-controlled, randomized, double-blind, clinical trial, involving 60 overweight individuals with MDD and pre-treatment cognitive dysfunction. Study participants will receive one of the following study interventions in addition to 'standard of care' treatment: once-daily semaglutide, 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; or matching placebo. Participants will be assessed to examine the effect of semaglutide on their cognitive function.

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
BIOLOGICAL	Semaglutide	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
BIOLOGICAL	Placebo	Semaglutide placebo capsules

Timeline

• Start date: 2021-10-06
• Primary completion: 2024-12-27
• Completion: 2024-12-27
• First posted: 2020-07-10
• Last updated: 2025-10-02

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated drug study