RecruitingPhase 4NCT07136714

Does Semaglutide Improve Depressive Symptoms in Patients With Major Depressive Disorder and Overweight or Obesity

Is the GLP-1 Receptor Agonist Semaglutide Able to Alleviate Mood in Patients With Major Depressive Disorder and Overweight or Obesity


Sponsor

Nordsjaellands Hospital

Enrollment

116 participants

Start Date

Sep 11, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This 26-week long, double-blinded randomized clinical trial aims to investigate the effects of semaglutide once-weekly vs. placebo on depressive symptoms in 116 patients with Major Depressive Disorder (MDD) and co-existing overweight or obesity. The treatment will be an add-on treatment to the patient's usual medication. The investigators hypothesize that adjunctive treatment with semaglutide, will lead to a significant improvement in mood compared to placebo in patients with MDD and overweight or obesity. The primary endpoint is the change in depressive symptoms measured as difference in the 12-item self-report mood questionnaire Major Depression Inventory (MDI) from start to follow-up after 26 weeks. The MDI measures the extent to which symptoms of depression have been present in the past two weeks.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether semaglutide (a medication already used for weight loss and diabetes) can also help reduce symptoms of depression in people who are overweight or obese and have been diagnosed with major depression. **You may be eligible if...** - You are 18 to 65 years old - You have been diagnosed with major depressive disorder (clinical depression) - Your depression symptoms are moderate to severe (as measured by a standard questionnaire) - Your body mass index (BMI) is 27 or higher (overweight or obese) - You can speak and understand Danish **You may NOT be eligible if...** - You are pregnant, planning to become pregnant in the next 9 months, or breastfeeding - You have a known allergy to GLP-1 medications (like semaglutide, Ozempic, or Wegovy) - You have severe liver, kidney, or heart problems - You have type 1 or type 2 diabetes, or a high blood sugar level - You currently have an active alcohol or drug problem - You are already taking diabetes or weight-loss medication - You are assessed as being at risk for suicide Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSemaglutide Injectable Product

Semaglutide (Wegovy) once-weekly injection s.c

DRUGPlacebo

Placebo (BD Posiflush) once-weekly injection s.c


Locations(1)

Mental Health Centre North Zealand

Hillerød, Denmark, Denmark

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NCT07136714


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