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New treatment option for Major Depressive Disorder
Official title Does Semaglutide Improve Depressive Symptoms in Patients With Major Depressive Disorder and Overweight or Obesity
ClinicalTrials.gov ID: NCT07136714
What this study is testing
What is Semaglutide Injectable Product?
Semaglutide Injectable Product is an investigational medicine, given as an once-weekly injectable medicine, being studied as a potential treatment for major depressive disorder.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Informed oral and written consent.
- Diagnosed with unipolar disorder according to the criteria of ICD10 (International Classification of Diseases, World Health Organization (WHO)) or...
- 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
You likely can't join if
- Any significant medical disorder or conditions that contraindicate the investigational drug, e.g., pregnancy, presence of known allergy GLP-1...
- Coercive measures
- Females of childbearing potential who are pregnant, breast-feeding or have the intention of becoming pregnant within the next 9 months (26 weeks plus...
- Patients treated with corticosteroids or other hormone therapy (except oestrogens).
- Any active substance abuse or dependence (except for nicotine)
- Impaired hepatic function (plasma liver transaminases \>2 times upper normal limit).
See the full eligibility criteria
- 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...
- 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
- 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...
- Coercive measures
- 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...
- Patients treated with corticosteroids or other hormone therapy (except oestrogens).
- Any active substance abuse or dependence (except for nicotine)
- Impaired hepatic function (plasma liver transaminases \>2 times upper normal limit).
- Impaired renal function (serum creatinine \>150 μmol/l)
- Cardiac problems defined as decompensated heart failure (NYHA class III/IV), unstable angina pectoris, and/or myocardial infarction within the last 12 months
- Hypertension with systolic blood pressure \>180 mmHg or diastolic blood pressure \>100 mmHg
- 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
- Use of diabetes medication or weight-lowering pharmacotherapy e.g. semagultid within the preceding 3 months
- Known type 1 and 2 diabetes or HbA1c\>48mmol/l
- 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...
- Any condition that the investigator feels would interfere with trial participation.
The study team makes the final eligibility decision.
Where it's taking place
- Hillerød, Denmark, Denmark
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hillerød, Denmark, Denmark. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.