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

NCT07136714 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 116

Last updated 2026-02-06

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Semaglutide Injectable Product

Semaglutide (Wegovy) once-weekly injection s.c

DRUG

Placebo

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

Sponsors & Collaborators

  • Nordsjaellands Hospital

    lead OTHER

Principal Investigators

  • Maj Vinberg, MD, PhD, DMSc · Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-11
Primary Completion
2027-09-30
Completion
2027-09-30

Countries

  • Denmark

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07136714 on ClinicalTrials.gov