Is the GLP-1 Receptor Agonist Semaglutide Able to Alleviate Mood in Patients With Major Depressive Disorder and Overweight or Obesity
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.
• Informed oral and written consent.
• Diagnosed with unipolar disorder according to the criteria of ICD10 (International Classification of Diseases, World Health Organization (WHO)) or the DSM-V (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, the American Psychiatric Association
• Hamilton Depression Rating Scale, 17-items (HDRS-17)47 score ≥14,
• Age 18 years to 65 years (both included)
• Body mass index (BMI) ≥27 kg/m2
• Able to speak and understand Danish