Actively Recruiting

Phase 4
Age: 18Years - 65Years
All Genders
NCT07136714

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

Led by Nordsjaellands Hospital · Updated on 2026-02-06

116

Participants Needed

1

Research Sites

102 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Provided informed oral and written consent
  • Diagnosed with unipolar disorder based on ICD-10 or DSM-V criteria
  • Hamilton Depression Rating Scale (17-items) score of 14 or higher
  • Aged between 18 and 65 years (inclusive)
  • Body mass index (BMI) of 27 kg/m2 or higher
  • Able to speak and understand Danish
Not Eligible

You will not qualify if you...

  • Any significant medical condition that contraindicates semaglutide, including pregnancy or known allergy to GLP-1 receptor agonists
  • Severe neurological disorders or ongoing drug or alcohol abuse
  • Under coercive measures
  • Females of childbearing potential who are pregnant, breastfeeding, planning pregnancy within 9 months, or not using effective contraception
  • Current treatment with corticosteroids or other hormone therapies except estrogens
  • Active substance abuse or dependence (except nicotine)
  • Impaired liver function (liver enzymes more than twice the upper normal limit)
  • Impaired kidney function (serum creatinine above 150 bcmol/l)
  • Recent serious heart problems such as unstable angina or heart attack within the last 12 months
  • High blood pressure above 180/100 mmHg
  • Impaired pancreatic function or pancreatitis
  • Use of experimental drugs within the past 3 months
  • Use of diabetes or weight-lowering medication including semaglutide in the last 3 months
  • Known type 1 or 2 diabetes or HbA1c above 48 mmol/l
  • Suicidal behavior as assessed by the investigator
  • Any condition that may interfere with trial participation

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Mental Health Centre North Zealand

Hillerød, Denmark, Denmark, 3400

Actively Recruiting

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Research Team

M

Maj Vinberg, MD, DMSc

CONTACT

C

Christoffer Stanislaus, MD, ph.d.-student

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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