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Study on the Effects of Escitalopram and Bupropion on Dopamine Levels in Patients with Major Depression

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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 changes in brain chemistry related to rewards in individuals with Major Depression and healthy volunteers. The study will explore how two different medications, escitalopram and bupropion, affect the brain's reward system in people with depression. Escitalopram is commonly known as Cipralex®, and bupropion is known as Wellbutrin XR®. Both medications are used to treat depression, but they work in different ways.

The purpose of the study is to understand how these medications influence the production of a brain chemical called dopamine, which is important for feeling pleasure and motivation. Participants will be given either escitalopram, bupropion, or a placebo, and their brain activity will be monitored over time. The study will use a special brain scan to measure changes in dopamine levels in a part of the brain called the nucleus accumbens, which is involved in the reward system.

Participants will be involved in the study for a period of time, during which they will take the medication and undergo regular assessments to track changes in their symptoms and brain activity. The study aims to provide insights into how these medications can help improve symptoms of depression by affecting the brain's reward system. This research could lead to better understanding and treatment options for people with Major Depression.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment will be conducted to confirm eligibility. This includes a review of medical history, a physical examination, and measurement of vital signs such as body temperature, blood pressure, and pulse rate.
Participants must meet specific health criteria, including age, weight, and body mass index (BMI) requirements. Visual and auditory capabilities will also be assessed to ensure suitability for neuropsychological testing.
Step 2
Informed consent
Participants will be required to provide written informed consent before any study procedures begin. This involves understanding the study's purpose, procedures, and potential risks and benefits.
Participants must demonstrate the ability to communicate effectively with the study team and comply with study requirements.
Step 3
Medication administration
Participants diagnosed with major depression will receive one of two medications: escitalopram oxalate or bupropion hydrochloride. These medications are administered orally in tablet form.
Escitalopram is provided as a 10 mg film-coated tablet, while bupropion is provided as a 150 mg modified-release tablet. The specific dosage and frequency will be determined by the study protocol and the participant's response to treatment.
Step 4
Monitoring and assessments
Throughout the study, participants will undergo regular monitoring to assess the effects of the medication. This includes evaluating changes in dopamine synthesis in the brain using imaging techniques.
Participants will also complete tasks designed to measure reward processing and response to treatment. These assessments help determine the relationship between dopamine synthesis and treatment outcomes.
Step 5
Follow-up and conclusion
At the end of the study period, participants will have a final assessment to evaluate overall health and any changes in symptoms of depression.
The study aims to identify changes in dopamine synthesis related to reward processing and assess the effectiveness of the medications in treating major depression.

Who can join the trial?

10 criteria

Participants must be male or female and between 18-65 years old.
For healthy participants: Scores on specific depression rating scales must be low (HDRS29 ≤ 8, MADRS ≤ 6, and BDI-II < 13).
For participants with depression: Must have a diagnosis of Major Depressive Disorder (MDD) according to a structured interview (SCID I) and specific depression rating scales.
Participants must be in good general health based on medical history, physical examination, and vital signs.
Vital signs, measured after resting, must be within these ranges: oral body temperature between 35.0-37.5 °C, systolic blood pressure 90-140 mmHg, diastolic blood pressure 50-90 mmHg, and pulse rate 40-100 beats per minute.
Participants must weigh between 50-100 kg and have a Body Mass Index (BMI) between 19-26.
Participants must have adequate vision and hearing for testing.
Participants must be willing and able to sign a consent form before starting the study.
Participants must be able to communicate well with the study team and follow the study requirements.
Only participants who are legally allowed to give consent will be included.

Who cannot join the trial?

10 criteria

Patients who are not diagnosed with Major Depression cannot participate.
Patients who are not within the age range of 18 to 65 years old cannot participate.
Patients who are not willing to take part in the study procedures cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients with a history of severe allergic reactions to the study medications cannot participate.
Patients who are currently participating in another clinical trial cannot participate.
Patients with certain medical conditions that might interfere with the study cannot participate.
Patients who have a history of substance abuse or dependence within the past year cannot participate.
Patients who have a significant risk of suicide cannot participate.
Patients who are unable to provide informed consent cannot participate.

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Medical University Of Vienna
Vienna, Austria

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Investigated drugs

Escitalopram
is a medication commonly used to treat depression and anxiety. It works by increasing the levels of a natural substance in the brain called serotonin, which helps improve mood and reduce feelings of anxiety. In this clinical trial, escitalopram is being used to see how it affects the brain's reward system and dopamine production in people with depression.
Bupropion
is another medication used to treat depression. It works differently from escitalopram by affecting the levels of certain chemicals in the brain, such as dopamine and norepinephrine, which can help improve mood and energy levels. In this study, bupropion is being tested to understand its impact on the brain's reward system and dopamine production in individuals with depression.

What is already known about the treatment

Escitalopram
Escitalopram is taken orally, usually in the form of a tablet or liquid, and is used to treat major depression. It is currently well-established in medical practice and literature as an effective antidepressant. The main therapeutic use of escitalopram is to alleviate symptoms of depression by increasing the levels of serotonin, a chemical in the brain that helps maintain mental balance. It belongs to a class of drugs known as selective serotonin reuptake inhibitors (SSRIs), which work by preventing the reabsorption of serotonin in the brain, thereby enhancing mood.
Bupropion
Bupropion is administered orally, typically as a tablet, and is used to treat major depression. It is recognized in medical literature as a useful antidepressant. The primary therapeutic indication for bupropion is to improve mood and feelings of well-being by affecting the balance of certain natural chemicals in the brain. It works by inhibiting the reuptake of dopamine and norepinephrine, which are neurotransmitters that play a role in mood regulation. Bupropion is classified as a norepinephrine-dopamine reuptake inhibitor (NDRI).

Investigated diseases

Major Depressive Disorder – Major Depressive Disorder is a mental health condition characterized by persistent feelings of sadness, hopelessness, and a lack of interest or pleasure in activities. It affects how a person feels, thinks, and handles daily activities. The disorder can lead to emotional and physical problems, impacting a person's ability to function at work and home. Symptoms may include changes in appetite, sleep disturbances, fatigue, and difficulty concentrating. The progression of the disorder can vary, with some individuals experiencing recurrent episodes. It is important to note that the severity and duration of symptoms can differ from person to person.