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Trial · Interventional

CompletedPhase 2Registry data

Semaglutide for the Treatment of Cognitive Dysfunction in Major Depressive Disorder

Overview

Status
Completed
Phase
Phase 2
Enrollment
72 participants (actual)
Sponsor
University Health Network, Toronto · Other
Design
Randomized · Triple masking
Countries
1 country

Canada

Start
6 Oct 2021
Primary completion
27 Dec 2024
Completion
27 Dec 2024
First posted
10 Jul 2020
Last update posted
2 Oct 2025
Conditions
Major Depressive Disorder

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20212022202320242025
  1. Ph 2

    Semaglutide for the Treatment of Cognitive Dysfunction in Major Depressive Disorder

    NCT04466345

    6 Oct 2021 to 27 Dec 2024

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

  • SemaglutideBiological
  • PlaceboBiological

Arms2

  • 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 outcomes1

Outcomes the sponsor listed as primary.

  1. Executive Function Composite Score

    Time frame · 16 Weeks

    Registry description

    The primary outcome will be an executive function composite score. This score will be comprised of the Digit Symbol Substitution Test (DSST - number of symbols), the Stroop test (time to completion in the congruent and incongruent conditions), and the Spatial n-back (reaction times and accuracy in four conditions,1-back, 2-back, 3-back, and 4-back).

Secondary outcomes(15)
  1. Digit Symbol Substitution Test (DSST)

    Time frame · 16 Weeks

    Registry description

    DSST is a neurocognitive test designed to assess motor speed and concentration.

  2. Rey Auditory Verbal Learning Test (RAVLT)

    Time frame · 16 Weeks

    Registry description

    RAVLT is a neurocognitive test designed to assess verbal learning and memory.

  3. Stroop Test

    Time frame · 16 Weeks

    Registry description

    The Stroop Test is a neurocognitive test designed to assess the ability to inhibit cognitive interference.

  4. Trail Making Test A (TMTA)

    Time frame · 16 Weeks

    Registry description

    TMTA is a neurocognitive test designed to assess visual scanning and attention.

  5. Perceived Deficits Questionnaire (PDQ)

    Time frame · 16 Weeks

    Registry description

    PDQ is used to assess subjective cognitive dysfunction.

  6. 36-Item Short Form Health Survey (SF-36)

    Time frame · 16 Weeks

    Registry description

    SF-36 is used to assess quality of life.

  7. Sheehan Disability Scale (SDS)

    Time frame · 12 Weeks

    Registry description

    SDS is used to assess functional impairment in work/school, social life, and family life.

  8. Endicott Workplace Productivity Scale (EWPS)

    Time frame · 16 Weeks

    Registry description

    EWPS is used to assess workplace productivity.

  9. Height

    Time frame · 16 Weeks

    Registry description

    Unit: cm

  10. Weight

    Time frame · 16 Weeks

    Registry description

    Unit: kg

  11. fasting glucose - Blood laboratorial marker

    Time frame · 16 Weeks

  12. Diet History Questionnaire III (DHQ)

    Time frame · 16 Weeks

    Registry description

    DHQ is a freely available questionnaire used to assess dietary intake (https://epi.grants.cancer.gov/dhq3/).

  13. Physical Activity Questionnaire (IPAQ)

    Time frame · 16 Weeks

    Registry description

    IPAQ is used to assess physical activity.

  14. Pittsburgh Sleep Quality Index (PSQI)

    Time frame · 16 Weeks

    Registry description

    PSQI is used to assess sleep quality.

  15. Trail Making Test B (TMTB)

    Time frame · 16 Weeks

    Registry description

    TMTB is a neurocognitive test designed to assess attention and concentration.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

Studies with results

2 studies on this page

Indexing hint: Randomized controlled trial · 2026

7 results

Semaglutide for the treatment of cognitive dysfunction in major depressive disorder: A randomized clinical trial.

Badulescu et al. 2026Med (New York, N.Y.)cited by 7

PMID 41218611DOI 10.1016/j.medj.2025.100916PUB-41218611

Full text at the publisher7 results

Indexing hint: Randomized controlled trial · 2026

4 results

Semaglutide and Effort-Based Decision-Making in Major Depressive Disorder: A Randomized Clinical Trial.

Gill et al. 2026JAMA psychiatry

PMID 42054055DOI 10.1001/jamapsychiatry.2026.0594PUB-42054055

Full text at the publisher4 results

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 60 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: 1. Informed consent before study-related activity 2. Individuals between the ages of 18 and 60 who meet Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria for MDD 3. Overweight (i.e. BMI ≥ 25 kg/m2) 4. Below-average (i.e. \>1 SD below norm) performance in the Trail Making Test-B (TMTB) Exclusion Criteria: 1. Current, or in the past 4 weeks, treatment with other oral hypoglycemic agents and/or insulin 2. Diagnosis of possible or probable Alzheimer's Disease, Mild Cognitive Impairment, or any other dementia 3. History of neurological disorder, or evidence of neurologic or other physical illness that could produce cognitive deterioration 4. Severe mood episode, defined as a Hamilton Depression Rating Scale (HAMD-17) score of \>23 5. 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). 6. Substance use disorder within 3 months before screening or a positive baseline toxicology screen 7. DSM-5 diagnosis of obsessive compulsive disorder, posttraumatic stress disorder (current or within the last year), or borderline personality disorder as assessed by a study investigator 8. Presence of absolute or relative contraindication to semaglutide (e.g. hypersensitivity to semaglutide, hepatic impairment, renal impairment with chronic kidney disease stage 3 and above, personal or familial history of medullary thyroid cancer or Multiple Endocrine Neoplasia syndrome type 2) 9. History of diabetic retinopathy 10. History of pancreatitis or pancreatic cancer 11. Presence of clinically unstable general medical illness 12. Pregnancy or breastfeeding women

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