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Glucagon-like peptide-1 receptor agonist

Semaglutide for Cognitive Impairment in Depression

Phase 2
Recruiting
Led By Rodrigo B. Mansur, MD, PhD
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Overweight (i.e. BMI ≥ 25 kg/m2)
Individuals between the ages of 18 and 60 who meet Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria for MDD
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16 weeks
Awards & highlights

Study Summary

This trial will test whether semaglutide can improve cognitive function in people with MDD.

Who is the study for?
This trial is for adults aged 18-60 with major depressive disorder (MDD) who have cognitive issues and are overweight. Participants must perform below average on a specific cognitive test and not be severely depressed, drug-dependent, pregnant, or breastfeeding. They can't have certain mental health conditions or be taking diabetes medications.Check my eligibility
What is being tested?
The study tests if semaglutide improves brain function in people with MDD. It's a comparison between semaglutide and a placebo (a substance with no active drug). Participants will receive either the real medication or placebo without knowing which one they're getting.See study design
What are the potential side effects?
Semaglutide may cause digestive problems like nausea, vomiting, diarrhea; risk of low blood sugar; possible thyroid tumors; pancreatitis; allergic reactions; kidney problems; changes in vision due to diabetic retinopathy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My BMI is 25 or higher, indicating I am overweight.
Select...
I am between 18 and 60 years old and have been diagnosed with major depression.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 16 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Executive Function Composite Score
Secondary outcome measures
36-Item Short Form Health Survey (SF-36)
Diet History Questionnaire III (DHQ)
Digit Symbol Substitution Test (DSST)
+12 more

Side effects data

From 2020 Phase 4 trial • 104 Patients • NCT04189848
21%
Nausea
12%
Decreased Appetite
100%
80%
60%
40%
20%
0%
Study treatment Arm
Overall Study

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: SemaglutideExperimental Treatment1 Intervention
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).
Group II: PlaceboPlacebo Group1 Intervention
Participants receive matching semaglutide placebo capsules once daily (duration of 16 weeks).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Semaglutide
2019
Completed Phase 4
~5160

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor
1,464 Previous Clinical Trials
483,541 Total Patients Enrolled
51 Trials studying Depression
11,874 Patients Enrolled for Depression
Rodrigo B. Mansur, MD, PhDPrincipal InvestigatorUniversity Health Network, Toronto

Media Library

Semaglutide (Glucagon-like peptide-1 receptor agonist) Clinical Trial Eligibility Overview. Trial Name: NCT04466345 — Phase 2
Depression Research Study Groups: Semaglutide, Placebo
Depression Clinical Trial 2023: Semaglutide Highlights & Side Effects. Trial Name: NCT04466345 — Phase 2
Semaglutide (Glucagon-like peptide-1 receptor agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04466345 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants being onboarded for this research trial?

"The clinical trial is actively searching for participants, with the initial posting occurring on October 6th 2021 and a subsequent update made on February 11th 2022. This can be verified through data hosted on clinicaltrials.gov."

Answered by AI

Are there any additional research initiatives exploring the efficacy of Semaglutide?

"As of now, 58 trials for Semaglutide are live. A total of 27 clinical studies are in the final phase before approval. Though the majority of research is conducted in Loma Linda, California, a staggering 3907 sites globally have initiated testing on this medication."

Answered by AI

What safeguards are in place to ensure patient safety when taking Semaglutide?

"Due to the lack of clinical data that verifies semaglutide's efficacy, it was assigned a score of 2 in regards to safety."

Answered by AI

Is this medical experiment the inaugural trial of its type?

"As of present, Novo Nordisk A/S sponsors 58 active Semaglutide studies across 772 cities and 55 countries. To date, 18433 trials have been initiated since the initial 2018 trial involving 1387 participants that reached Phase 4 in its drug approval process."

Answered by AI

Is the age of 75+ a criterion for enrollment in this trial?

"According to the inclusion criteria, only individuals aged 18-60 can participate in this research. Patients under 18 and those over 65 have been enrolled into 223 and 1529 studies respectively."

Answered by AI

In what instances is Semaglutide typically prescribed?

"Semaglutide is regularly used to manage obesity and may be prescribed in conjunction with a reduced-calorie diet, physical activity, and at least one weight-related comorbidity."

Answered by AI

What are the eligibility criteria for participation in this clinical trial?

"This clinical trial is accepting applications from individuals aged 18-60 who are experiencing symptoms of melancholia. A total of 60 people will participate in the study."

Answered by AI

What is the cap on participant numbers for this clinical trial?

"Confirmed. The trial details available on clinicaltrials.gov reveal that this medical experiment, which was first published on October 6th 2021, is actively recruiting participants. Approximately 60 patients will be taken in by a single site and enrolled in the study."

Answered by AI
~10 spots leftby Oct 2024