RecruitingPhase 4NCT06675851

Reward-specific Changes of the Chemical Messenger Dopamine in the Brain of Healthy and Depressed People

Reward-specific Changes of Cerebral Dopamine Synthesis in Healthy Volunteers and Depressed Patients


Sponsor

Medical University of Vienna

Enrollment

120 participants

Start Date

Dec 1, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

Major depressive disorder was shown to be associated with pathological alterations within neurotransmitter systems of the brain. Based on earlier study results, it is assumed that the neurotransmitter dopamine is relevant for several symptoms of depression, e.g., loss of interest or pleasure and lack of motivation. Thus, it is assumed that the synthesis of dopamine in the brain of depressed individuals could be impaired. The specific effect of common antidepressants on the human reward system in depression has not yet been sufficiently investigated. In particular, it is unclear whether depressed patients exhibit reward-specific changes of dopamine synthesis, and whether or not these changes can be differentially affected by diverse types of antidepressants. Neurotransmitter systems can be visualized in the brain using positron emission tomography (PET). Additionally, brain structure and function can be studied using magnetic resonance imaging (MRI). For the visualization of dopamine synthesis in the brain, the radioligand \[18F\]FDOPA can be used in PET measurements. To assess task-relevant changes of diverse radioligands and thus specific metabolic processes in the brain during specific tasks, a recently developed PET-approach can be used which has already been successfully applied in a pilot study with healthy volunteers. In the present project, 60 depressed subjects and 30 healthy controls will undergo PET/MR-imaging twice. Depressed subjects will be assigned to 1 of 2 treatment groups. 30 depressive subjects will receive bupropion, the other 30 patients will be treated with escitalopram. After a treatment period of 6 weeks, the 2nd PET measurement will be performed in all participants, aiming to detect potential reward-specific changes of dopamine synthesis. The investigators hypothesize that reward-specific changes of dopamine synthesis will be lower in depressed subjects than in healthy controls, that reward-specific changes of dopamine synthesis will be significantly higher in the bupropion group than in the escitalopram group, and that the changes of dopamine synthesis will be associated with functional changes in the brain (measured by simultaneous functional MRI scans). This will be the first study comparing the effects of escitalopram and bupropion on task-specific dopamine synthesis and thus on the human reward system. The study is expected to yield new insights for individual treatment concepts in the therapy of depression.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is using a brain imaging technique called PET scanning to measure real-time changes in dopamine — the brain's reward chemical — in both healthy people and people with depression. The goal is to better understand how dopamine responds differently to rewards in depression, which may explain symptoms like loss of pleasure or motivation. **You may be eligible if...** - You are between 18 and 65 years old - You are either in good general health (healthy volunteer) OR you have a confirmed diagnosis of major depressive disorder (MDD) - Your weight is between 50–100 kg with a BMI of 19–26 - Your vital signs (blood pressure, heart rate, temperature) are within normal ranges - You have adequate vision and hearing for neuropsychological testing **You may NOT be eligible if...** - You are taking antidepressants, antipsychotics, or other psychiatric medications that would interfere with dopamine measurement - You have a history of substance abuse or addiction - You have a pacemaker or metal implant that prevents brain scanning - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGWELLBUTRIN SR (Bupropion HCI) Sustained-Release Tablets, 150 mg; GlaxoSmithKline

Bupropion 150 mg daily after baseline PET/MRI or MRI/MRS over 6-8 weeks

DRUGCipralex (escitalopram)

Escitalopram 10 mg daily after baseline PET/MRI or MRI/MRS over 6-8 weeks


Locations(1)

Medical University of Vienna

Vienna, Austria

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NCT06675851


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