BridgeMD
Sema.Mood
EU CTIS ID: 2024-511734-13-04
What this study is testing
Primary outcome. The primary endpoint is the change in depressive symptoms measured as the difference in the 12-item self-report mood questionnaire Major Depression Inventory (MDI)48 from week 0 to week 26. MDI estimates depression symptom severity and the patients will rate how much time in the past two weeks each of the symptoms of the depressive syndrome is present
- Phase III and phase IV (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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 ≥13, 4. Age 18 years to 70 years (both included) 5. Body mass index (BMI) ≥27 kg/m2
You likely can't join if
- 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, diabetes I, on-going drug, or alcohol abuse 2. Coercive measures 3. Females of child-bearing potential who are pregnant, breastfeeding, or have the intention of becoming pregnant 4. Women who are not willing to use an adequate contraceptive during the full length of the study 5. Patients treated with corticosteroids or other hormone therapy (except oestrogens). 6. Any active substance abuse or dependence (except for nicotine) 7. Impaired hepatic function (plasma liver transaminases >2 times upper normal limit). 8. Impaired renal function (serum creatinine >150 μmol/l) 9. Impaired pancreatic function (acute or chronic pancreatitis and/or plasma amylase >2 times upper normal limit) 10. Cardiac problems defined as decompensated heart failure (NYHA class III/IV), unstable angina pectoris, and/or myocardial infarction within the last 12 months 11. Hypertension with systolic blood pressure >180 mmHg or diastolic blood pressure >100 mmHg 12. 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 13. Use of diabetes medication or weight-lowering pharmacotherapy within the preceding 3 months 14. Known type 1 and 2 diabetes or HbA1c>48mmol/mol 15. No glucose-lowering medication is allowed for the trial 16. Suicidal 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 17. Any condition that the investigator feels would interfere with trial participation
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.