CompletedPhase 2

Semaglutide for the Treatment of Cognitive Dysfunction in Major Depressive Disorder

Canada72 participantsStarted 2021-10-06

Plain-language summary

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

Age range18 Years – 60 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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)

✕. 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)

Executive Function Composite Score

Timeframe: 16 Weeks

NCT IDNCT04466345

SponsorUniversity Health Network, Toronto

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-27

Who can participate

Age range18 Years – 60 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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)

✕. 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)