RecruitingNot ApplicableNCT05909267

Dopamine Modulation of Motivation and Motor Function in Major Depression & Inflammation

Effects of Pharmacological Dopamine Modulation on Motivation and Motor Function in Major Depression Characterized by Low-grade Inflammation.


Sponsor

Charite University, Berlin, Germany

Enrollment

165 participants

Start Date

Jul 26, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

A large body of evidence on depression heterogeneity point to an "immunometabolic" subtype characterized by the clustering of immunometabolic dysregulations with atypical behavioral symptoms related to energy homeostasis. Motivational and motor impairments reflected by symptoms of anhedonia and psychomotor retardation in major depression are closely related to alterations in energy homeostasis, are associated with increased inflammation, and may be a direct consequence of the impact of inflammatory cytokines on the dopamine system in the brain. In the proposed project, the investigators will examine the effect of dopamine stimulation on motivation and motor function in patients with major depression and healthy controls and the role of inflammation using a double-blind, randomized, placebo-controlled, cross-over design. If successful, this study would provide crucial evidence that pharmacologic strategies that increase dopamine may effectively treat inflammation-related symptoms of anhedonia and psychomotor retardation in major depression.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating how dopamine — a brain chemical involved in motivation, movement, and mood — is affected in people with major depression who also have signs of inflammation in their body. Researchers want to understand why some people with depression feel unmotivated and move more slowly, and whether inflammation plays a role. **You may be eligible if (patients with depression)...** - You have been diagnosed with major depressive disorder - You are not currently taking antidepressant medication **You may be eligible if (healthy volunteers)...** - You have no current psychiatric diagnosis - You are not on antidepressants - Your inflammation marker (CRP) is very low **You may NOT be eligible if...** - You have schizophrenia, bipolar disorder, or active alcohol/drug dependence - You have neurological disease, epilepsy, glaucoma, or asthma - You have a history of peptic ulcer or melanoma - You have active infections or chronic inflammatory conditions (like rheumatoid arthritis) - You are pregnant or breastfeeding - You are severely obese (BMI 40 or higher) 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

DRUGL-dopa/Carbidopa

Patients and healthy controls will receive one time administration of L-dopa/Carbidopa (100/25 mg).

DRUGPlacebo

Patients and healthy controls will receive one time administration of Placebo.


Locations(1)

Klinik für Psychiatrie und Psychotherapie

Steglitz, Germany

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NCT05909267


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