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Does Semaglutide Improve Depressive Symptoms in Patients With Major Depressive Disorder and Overweight or Obesity (SEMAMOOD) Phase 4 116 Randomized Double-Blind

Recruiting
Clinical Trial NCT07136714 (SEMAMOOD) is designed to study Treatment for Major Depressive Disorder. It is a Phase 4 interventional study that is recruiting, having started on September 11, 2025, with plans to enroll 116 participants. Led by Nordsjaellands Hospital, it is expected to complete by September 1, 2027. The latest data from ClinicalTrials.gov was last updated on February 6, 2026.
Brief 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 signific...Show More
Detailed Description
This 26 week, randomized, double-blinded, placebo-controlled clinical trial investigate effects of semaglutide once-weekly vs. placebo on depressive symptoms in patients with unipolar disorder and comorbid obesity or overweight aged 18 years to 65 years. 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 ...Show More
Official Title

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

Conditions
Major Depressive Disorder
Other Study IDs
  • SEMAMOOD
  • 2024-511734-13-04
  • 2024-511734-13-04 (EU Study (CTIS) Number)
NCT ID Number
NCT07136714
Start Date (Actual)
2025-09-11
Last Update Posted
2026-02-06
Completion Date (Estimated)
2027-09
Enrollment (Estimated)
116
Study Type
Interventional
PHASE
Phase 4
Status
Recruiting
Keywords
GLP-1
Glucagon-like peptide 1
Semaglutide
Depression
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Quadruple
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalSemaglutide
Wegovy once--weekly s.c titrated to max dose of 2.4 mg
Semaglutide Injectable Product
Semaglutide (Wegovy) once-weekly injection s.c
Placebo ComparatorPlacebo
Saline s.c. once-weekly
Placebo
Placebo (BD Posiflush) once-weekly injection s.c
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Change in depressive symptoms
Change in depressive symptoms measured by the Major Depression Inventory (MDI; 12-item self-report mood questionnaire). The scale ranges from 0 to 50, with higher scores indicating worse outcome.
From baseline to 26 weeks of treatment
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Glycaemic control parameters (blood sampling)
Changes in HbA1c levels
From baseline to 26 weeks of treatment
Body weight
Change in body weight in kilograms (kg).
From baseline to 26 weeks
Waist circumference
Change in waist circumference in centimeters (cm).
From baseline to 26 weeks of treatment
Hamilton Depression Rating Scale, 17-items (HDRS-17) score
Change in depressive symptoms measured by the Hamilton Depression Rating Scale, 17-items (HDRS-17) score. The scale ranges from 0 to 52, with higher scores indicating worse outcome.
From baseline to 26 weeks of treatment
Functioning assessment short test (FAST) score
Changes in Functioning assessment short test (FAST) score. Total score in the range 0-72, where higher scores reflect more serious functional impairment
From baseline to 26 weeks of treatment
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  1. Informed oral and written consent.
  2. 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
  3. Hamilton Depression Rating Scale, 17-items (HDRS-17)47 score ≥14,
  4. Age 18 years to 65 years (both included)
  5. Body mass index (BMI) ≥27 kg/m2
  6. Able to speak and understand Danish

  1. Any significant medical disorder or conditions that contraindicate the investigational drug, e.g., pregnancy, presence of known allergy GLP-1 receptor agonists, severe neurological disorder, on-going drug, or alcohol abuse
  2. Coercive measures
  3. Females of childbearing potential who are pregnant, breast-feeding or have the intention of becoming pregnant within the next 9 months (26 weeks plus two months after discontinuation of semaglutide), or are not using contraceptives (during the whole study period) considered as highly effective (combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable) intrauterine device - IUD, IUS, bilateral tubal occlusion, vasectomised partner, sexual abstinence)
  4. Patients treated with corticosteroids or other hormone therapy (except oestrogens).
  5. Any active substance abuse or dependence (except for nicotine)
  6. Impaired hepatic function (plasma liver transaminases >2 times upper normal limit).
  7. Impaired renal function (serum creatinine >150 μmol/l)
  8. Cardiac problems defined as decompensated heart failure (NYHA class III/IV), unstable angina pectoris, and/or myocardial infarction within the last 12 months
  9. Hypertension with systolic blood pressure >180 mmHg or diastolic blood pressure >100 mmHg
  10. Impaired pancreatic function (acute or chronic pancreatitis and/or plasma amylase >2 times upper normal limit). Receiving any experimental or pre-marketing drug within the last 3 months
  11. Use of diabetes medication or weight-lowering pharmacotherapy e.g. semagultid within the preceding 3 months
  12. Known type 1 and 2 diabetes or HbA1c>48mmol/l
  13. Suicidal behaviour as judged by the investigator and based on clinical evaluation. At all contact with patient attendance (please see Table 1) possible suicidality will be evaluatedaccording to the guidelines. If the patient is evaluated as suicidal, the person will be excluded from the study and evaluated by a senior consultant in psychiatry, who will take further action.
  14. Any condition that the investigator feels would interfere with trial participation.
Nordsjaellands Hospital logoNordsjaellands Hospital
Study Responsible Party
Maj Vinberg, Principal Investigator, MD, DMSc, Professor, Nordsjaellands Hospital
Study Central Contact
Contact: Maj Vinberg, MD, DMSc, + 45 38 64 32 27, [email protected]
Contact: Christoffer Stanislaus, MD, ph.d.-student, [email protected]
1 Study Locations in 1 Countries

Denmark

Mental Health Centre North Zealand, Hillerød, Denmark, 3400, Denmark
Maj Vinberg, MD, DMSc, Professor, Contact, +45 38643227, [email protected]
Christoffer Stanislaus, MD, ph.d.-student, Contact
Recruiting