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

Study acronym: SEMAMOOD
StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Lead sponsor: Maj Vinberg to Nordsjaellands Hospitalv3
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Sep 1, 2025 to Sep 11, 2025
    • Site details revised
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07136714
Lead Sponsor Nordsjaellands Hospital
Conditions
(from sponsor)		 Major Depressive Disorder
Related terms Depression, Major Depressive Disorder
Enrollment 116 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov