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Study on the Effects of Semaglutide on Mood in Patients with Major Depressive Disorder and Overweight or Obesity

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a medication called semaglutide on individuals with major depressive disorder who are also experiencing overweight or obesity. The medication, known by the brand name Wegovy, is administered as a solution for injection using a pre-filled pen. The study aims to explore whether semaglutide can help improve mood in patients with depression.

Participants in the study will receive different doses of Wegovy, ranging from 0.25 mg to 2.4 mg, over a period of several weeks. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects. The study will monitor changes in depressive symptoms using a questionnaire called the Major Depression Inventory, which helps assess the severity of depression symptoms over time.

In addition to evaluating mood changes, the study will also look at other health factors such as body weight, waist and hip measurements, blood sugar levels, and overall quality of life. The goal is to understand how semaglutide affects both mental and physical health in individuals with depression and weight concerns. The study is expected to continue until 2027, providing valuable insights into the potential benefits of semaglutide for this group of patients.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, you will receive a detailed explanation of the trial process. You will be asked to provide informed oral and written consent, confirming your understanding and willingness to participate.
Step 2
Initial assessment
An initial assessment will be conducted to confirm your eligibility. This includes verifying your diagnosis of unipolar depression and checking your body mass index (BMI) to ensure it is 27 kg/m² or higher.
Step 3
Baseline measurements
Baseline measurements will be taken, including your weight, hip and waist circumference, and other health indicators. You will also complete a 12-item self-report mood questionnaire called the Major Depression Inventory (MDI) to assess your current depressive symptoms.
Step 4
Medication administration
You will begin receiving the medication semaglutide through a subcutaneous injection (an injection under the skin). The dosage will start at 0.25 mg and will gradually increase over time to a maximum of 2.4 mg as per the study protocol. The injections will be administered once a week.
Step 5
Ongoing assessments
Throughout the study, you will have regular assessments to monitor your progress. These will include repeating the MDI questionnaire to track changes in your depressive symptoms, as well as measuring your weight and other health indicators.
Step 6
Completion of the study
The study will last for a total of 26 weeks. At the end of the study, final assessments will be conducted to evaluate the overall impact of the treatment on your depressive symptoms and other health measures.

Who can join the trial?

5 criteria

Provide informed consent, which means you agree to participate after understanding the study details.
Have a diagnosis of unipolar disorder according to the criteria of ICD10 or DSM-V. These are systems used by doctors to classify mental health conditions.
Have a score of 13 or higher on the Hamilton Depression Rating Scale (HDRS-17), a questionnaire used to measure the severity of depression.
Be between the ages of 18 and 70, including both ages.
Have a Body Mass Index (BMI) of 27 kg/m² or higher. BMI is a number calculated from your weight and height to determine if you are overweight.

Who cannot join the trial?

10 criteria

Patients with a history of **bipolar disorder** (a mental health condition causing extreme mood swings) cannot participate.
Patients with **schizophrenia** (a mental disorder affecting how a person thinks, feels, and behaves) are excluded.
Individuals with **substance abuse** issues (problems with drugs or alcohol) are not eligible.
Patients who have had a **major depressive episode** within the last month are not allowed to join.
People with **uncontrolled medical conditions** (health issues that are not being managed well) cannot take part.
Pregnant or breastfeeding women are not eligible for the study.
Individuals currently participating in another clinical trial are excluded.
Patients who have had **electroconvulsive therapy** (a treatment for severe depression involving electrical stimulation of the brain) in the past three months cannot participate.
People with **severe cognitive impairment** (serious problems with memory or thinking) are not eligible.
Individuals with **suicidal thoughts** or behaviors are excluded from the study.

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Verified sites

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Hillerod Hospital
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Hillerød, Denmark

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Investigated drugs

Semaglutide is a medication that is being studied to see if it can help improve mood in people who have major depressive disorder and are also overweight or obese. It works by mimicking a hormone in the body that helps control blood sugar levels and appetite. Researchers are interested in finding out if this medication can also have a positive effect on mood and reduce symptoms of depression.

What is already known about the treatment

Semaglutide – Semaglutide is administered as an injection under the skin, typically once a week. It is currently being studied for its potential to improve mood in people with major depressive disorder who are also overweight or obese. The main therapeutic use of semaglutide is to help with weight management and control blood sugar levels in people with type 2 diabetes. At the molecular level, semaglutide works by mimicking a hormone called GLP-1, which helps regulate appetite and insulin production. It belongs to a class of drugs known as GLP-1 receptor agonists.

Investigated diseases

Major Depressive Disorder
Major Depressive Disorder is a mental health condition characterized by persistent feelings of sadness and a lack of interest in activities. It affects how a person feels, thinks, and handles daily activities. Symptoms may include changes in appetite, sleep disturbances, fatigue, and difficulty concentrating. The disorder can lead to emotional and physical problems, impacting a person's ability to function at work or home. It often involves episodes that can last for weeks or longer. The severity and duration of these episodes can vary among individuals.
Obesity
Obesity is a condition where excess body fat accumulates to the extent that it may have a negative effect on health. It is typically measured using the Body Mass Index (BMI), with a BMI of 30 or higher indicating obesity. The condition develops gradually over time, often due to a combination of excessive calorie intake, lack of physical activity, and genetic factors. Obesity can lead to various health issues, including cardiovascular diseases, type 2 diabetes, and certain types of cancer. It can also affect mobility and lead to joint problems. The progression of obesity can be influenced by lifestyle, environment, and metabolic factors.