Status:
COMPLETED
Semaglutide for the Treatment of Cognitive Dysfunction in Major Depressive Disorder
Lead Sponsor:
University Health Network, Toronto
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief 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 o...
Eligibility Criteria
Inclusion
- 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
- 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
- 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
- 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)
- History of diabetic retinopathy
- History of pancreatitis or pancreatic cancer
- Presence of clinically unstable general medical illness
- Pregnancy or breastfeeding women
Key Trial Info
Start Date :
October 6 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 27 2024
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT04466345
Start Date
October 6 2021
End Date
December 27 2024
Last Update
October 2 2025
Active Locations (1)
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1
Toronto Western Hospital
Toronto, Ontario, Canada, M5T 2S8