NCT05909267

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.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 165 (estimated)
• Sponsor: Charite University, Berlin, Germany · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Depressive Disorder, Major

Interventions

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

Timeline

• Start date: 2023-07-26
• Primary completion: 2026-07-01
• Completion: 2026-07-01
• First posted: 2023-06-18
• Last updated: 2026-03-18

Locations

1 site across 1 country: Germany