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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorCharite University, Berlin, Germany

About this trial

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 criteria

Qualifiers

diagnosis of major depressive disorder according to DSM-5

free of antidepressant medication

C-reactive protein (CRP): ≤ 1 mg/l

free of antidepressant medication

Disqualifiers

diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, dementia, and current/past alcohol or drug dependence

central nervous system diseases

neurological diseases

suspicious undiagnosed skin lesions or a history of melanoma

Trial design

Treatments tested in this trial

  • L-dopa/Carbidopa
  • Placebo

Treatment groups

165 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Charite University, Berlin, Germany

Lead sponsor

Prof. Dr. Stefan M. Gold

Collaborator

Prof. Dr. Soyoung Q Park

Collaborator

Dr. Ulrike Grittner

Collaborator

Motognosis GmbH

Collaborator