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RECRUITING
NCT07136714
PHASE4

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

Sponsor: Nordsjaellands Hospital

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

116

Start Date

2025-09-11

Completion Date

2027-09

Last Updated

2026-02-06

Healthy Volunteers

No

Interventions

DRUG

Semaglutide Injectable Product

Semaglutide (Wegovy) once-weekly injection s.c

DRUG

Placebo

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

Locations (1)

Mental Health Centre North Zealand

Hillerød, Denmark, Denmark