Semaglutide for the Treatment of Cognitive Dysfunction in Major Depressive Disorder

Sponsor
University Health Network, Toronto
Study ID
NCT04466345
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • Semaglutide — BIOLOGICAL
    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
  • Placebo — BIOLOGICAL
    Semaglutide placebo capsules

Study Details

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

Key Dates

Start date
Oct 6, 2021
Status verified
Aug 2024
Primary completion
Dec 27, 2024
Completion
Dec 27, 2024

Study Design

Enrollment
72 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Semaglutide
    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).
  • Placebo Comparator: Placebo
    Participants receive matching semaglutide placebo capsules once daily (duration of 16 weeks).

Primary Outcome Measure

Executive Function Composite Score [ Time Frame: 16 Weeks ]

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