Back to resultsSemaglutide for the Treatment of Cognitive Dysfunction in Major Depressive Disorder
Primary Purpose
Major Depressive Disorder
Status
Recruiting
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Semaglutide
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Major Depressive Disorder
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- Toronto Western HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Semaglutide
Placebo
Arm Description
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).
Participants receive matching semaglutide placebo capsules once daily (duration of 16 weeks).
Outcomes
Primary Outcome Measures
Executive Function Composite Score
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 Outcome Measures
Digit Symbol Substitution Test (DSST)
DSST is a neurocognitive test designed to assess motor speed and concentration.
Rey Auditory Verbal Learning Test (RAVLT)
RAVLT is a neurocognitive test designed to assess verbal learning and memory.
Stroop Test
The Stroop Test is a neurocognitive test designed to assess the ability to inhibit cognitive interference.
Trail Making Test A (TMTA)
TMTA is a neurocognitive test designed to assess visual scanning and attention.
Perceived Deficits Questionnaire (PDQ)
PDQ is used to assess subjective cognitive dysfunction.
36-Item Short Form Health Survey (SF-36)
SF-36 is used to assess quality of life.
Sheehan Disability Scale (SDS)
SDS is used to assess functional impairment in work/school, social life, and family life.
Endicott Workplace Productivity Scale (EWPS)
EWPS is used to assess workplace productivity.
Height
Unit: cm
Weight
Unit: kg
fasting glucose - Blood laboratorial marker
Diet History Questionnaire III (DHQ)
DHQ is a freely available questionnaire used to assess dietary intake (https://epi.grants.cancer.gov/dhq3/).
Physical Activity Questionnaire (IPAQ)
IPAQ is used to assess physical activity.
Pittsburgh Sleep Quality Index (PSQI)
PSQI is used to assess sleep quality.
Trail Making Test B (TMTB)
TMTB is a neurocognitive test designed to assess attention and concentration.
Full Information
NCT ID
NCT04466345
First Posted
June 8, 2020
Last Updated
September 19, 2023
Sponsor
University Health Network, Toronto
1. Study Identification
Unique Protocol Identification Number
NCT04466345
Brief Title
Semaglutide for the Treatment of Cognitive Dysfunction in Major Depressive Disorder
Official Title
Adjunctive Semaglutide for the Treatment of Cognitive Dysfunction in Major Depressive Disorder: a Randomized, Double-Blind, Placebo-Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 6, 2021 (Actual)
Primary Completion Date
October 5, 2024 (Anticipated)
Study Completion Date
October 5, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Semaglutide
Arm Type
Experimental
Arm Description
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).
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants receive matching semaglutide placebo capsules once daily (duration of 16 weeks).
Intervention Type
Biological
Intervention Name(s)
Semaglutide
Intervention Description
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
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Semaglutide placebo capsules
Primary Outcome Measure Information:
Title
Executive Function Composite Score
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).
Time Frame
16 Weeks
Secondary Outcome Measure Information:
Title
Digit Symbol Substitution Test (DSST)
Description
DSST is a neurocognitive test designed to assess motor speed and concentration.
Time Frame
16 Weeks
Title
Rey Auditory Verbal Learning Test (RAVLT)
Description
RAVLT is a neurocognitive test designed to assess verbal learning and memory.
Time Frame
16 Weeks
Title
Stroop Test
Description
The Stroop Test is a neurocognitive test designed to assess the ability to inhibit cognitive interference.
Time Frame
16 Weeks
Title
Trail Making Test A (TMTA)
Description
TMTA is a neurocognitive test designed to assess visual scanning and attention.
Time Frame
16 Weeks
Title
Perceived Deficits Questionnaire (PDQ)
Description
PDQ is used to assess subjective cognitive dysfunction.
Time Frame
16 Weeks
Title
36-Item Short Form Health Survey (SF-36)
Description
SF-36 is used to assess quality of life.
Time Frame
16 Weeks
Title
Sheehan Disability Scale (SDS)
Description
SDS is used to assess functional impairment in work/school, social life, and family life.
Time Frame
12 Weeks
Title
Endicott Workplace Productivity Scale (EWPS)
Description
EWPS is used to assess workplace productivity.
Time Frame
16 Weeks
Title
Height
Description
Unit: cm
Time Frame
16 Weeks
Title
Weight
Description
Unit: kg
Time Frame
16 Weeks
Title
fasting glucose - Blood laboratorial marker
Time Frame
16 Weeks
Title
Diet History Questionnaire III (DHQ)
Description
DHQ is a freely available questionnaire used to assess dietary intake (https://epi.grants.cancer.gov/dhq3/).
Time Frame
16 Weeks
Title
Physical Activity Questionnaire (IPAQ)
Description
IPAQ is used to assess physical activity.
Time Frame
16 Weeks
Title
Pittsburgh Sleep Quality Index (PSQI)
Description
PSQI is used to assess sleep quality.
Time Frame
16 Weeks
Title
Trail Making Test B (TMTB)
Description
TMTB is a neurocognitive test designed to assess attention and concentration.
Time Frame
16 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rodrigo B. Mansur, MD, PhD
Phone
416 603 5106
Email
rodrigo.mansur@uhn.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rodrigo B. Mansur, MD, PhD
Organizational Affiliation
University Health Network, Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Toronto Western Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joshua Di Vincenzo
Email
joshua.divincenzo@uhnresearch.ca
12. IPD Sharing Statement
Learn more about this trial
Semaglutide for the Treatment of Cognitive Dysfunction in Major Depressive Disorder
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