SEMAGLUTIDE for Major depressive disorder | Obesity | Overweight

Inclusion criteria

• {"criterion_text":"- 1.\tInformed oral and written consent."}
• {"criterion_text":"- 2.\tDiagnosed 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"}
• {"criterion_text":"- 3.\tHamilton Depression Rating Scale, 17-items (HDRS-17)47 score ≥13,"}
• {"criterion_text":"- 4.\tAge 18 years to 70 years (both included)"}
• {"criterion_text":"- 5.\tBody mass index (BMI) ≥27 kg/m2"}

Exclusion criteria

• {"criterion_text":"- 1.\tAny significant medical disorder or conditions that contraindicate the investigational drug, e.g., pregnancy, presence of known allergy GLP-1 receptor agonists, severe neurological disorder, diabetes I, on-going drug, or alcohol abuse"}
• {"criterion_text":"- 2.\tCoercive measures"}
• {"criterion_text":"- 3.\tFemales of child-bearing potential who are pregnant, breastfeeding, or have the intention of becoming pregnant"}
• {"criterion_text":"- 4.\tWomen who are not willing to use an adequate contraceptive during the full length of the study"}
• {"criterion_text":"- 5.\tPatients treated with corticosteroids or other hormone therapy (except oestrogens)."}
• {"criterion_text":"- 6.\tAny active substance abuse or dependence (except for nicotine)"}
• {"criterion_text":"- 7.\tImpaired hepatic function (plasma liver transaminases >2 times upper normal limit)."}
• {"criterion_text":"- 8.\tImpaired renal function (serum creatinine >150 μmol/l)"}
• {"criterion_text":"- 9.\tImpaired pancreatic function (acute or chronic pancreatitis and/or plasma amylase >2 times upper normal limit)"}
• {"criterion_text":"- 10.\tCardiac problems defined as decompensated heart failure (NYHA class III/IV), unstable angina pectoris, and/or myocardial infarction within the last 12 months"}
• {"criterion_text":"- 11.\tHypertension with systolic blood pressure >180 mmHg or diastolic blood pressure >100 mmHg"}
• {"criterion_text":"- 12.\tImpaired 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"}
• {"criterion_text":"- 13.\tUse of diabetes medication or weight-lowering pharmacotherapy within the preceding 3 months"}
• {"criterion_text":"- 14.\tKnown type 1 and 2 diabetes or HbA1c>48mmol/mol"}
• {"criterion_text":"- 15.\tNo glucose-lowering medication is allowed for the trial"}
• {"criterion_text":"- 16.\tSuicidal behaviour as judged by the investigator and based on clinical evaluation. At all contact with patient attendance (except DXA scanning visits, please see Table 1) possible suicidality will be evaluated according 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"}
• {"criterion_text":"- 17.\tAny condition that the investigator feels would interfere with trial participation"}

Primary endpoints

• {"endpoint_text":"- The primary outcome will be change in Major Depression Inventory from baseline to end of study","definition_or_measurement_approach":"Change in depressive symptoms measured as the difference in the 12-item self-report Major Depression Inventory (MDI) from week 0 (baseline) to week 26 (end of study)."}

Secondary endpoints

• {"endpoint_text":"- Secondary outcomes include changes in body weight, hip and waist circumference, hemoglobin A1c lean and fat body mass and bone density, biomarkers related to inflammation, and oxidative stress and further overall functioning, quality of life, perceived stress, and cognitive scores","definition_or_measurement_approach":"Includes changes in body weight, hip and waist circumference, HbA1c, lean and fat body mass and bone density, biomarkers related to inflammation and oxidative stress, global functioning, cognition, and quality of life (as stated in secondary objectives and endpoints). Specific measurement instruments for each outcome are not detailed in the provided JSON."}

Methods

• ForskningNu (document present titled 'ForskningNu') - recruitment material/document likely targeted to Danish research portal/public (Denmark).
• Poster recruitment (document 'PosterRecruitmentClean') - poster materials for recruitment (Denmark).
• Patient information / participant leaflet (documents titled 'PatientfolderMarchCleanVersion', 'DeltagerinformationSemaMood_CleanVersion_FourRFI') - provided to potential participants (Denmark).
• Recruitment arrangements documents ('RecruitmentArrangements_CleanVersion_OneRFI' and track changes versions) - study-specific recruitment arrangements (Denmark).

Denmark

Earliest CTIS Part Ii Submission Date

14-04-2025

Latest Decision Or Authorization Date

07-05-2025

Processing Time Days

23

Number Of Sites

1

Number Of Participants

120

Primary sponsor

Full Name

Region Hovedstaden

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Denmark

Third parties

• {"country":"Denmark","full_name":"Frederiksberg Hospital","duties_or_roles":"sponsorDuties code 1","organisation_type":"Hospital/Clinic/Other health care facility"}