L-dopa/Carbidopa: Patients and healthy controls will receive one time administration of L-dopa/Carbidopa (100/25 mg).
Placebo: Patients and healthy controls will receive one time administration of Placebo.
Study 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
Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
Accepted
Inclusion Criteria:
For patients with major depressive disorder:
* diagnosis of major depressive disorder according to DSM-5
* free of antidepressant medication
For healthy participants:
* C-reactive protein (CRP): ≤ 1 mg/l
* free of antidepressant medication
* free of any current psychiatric disorder
Exclusion Criteria:
* 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
* narrow-angle or wide-angle glaucoma
* bronchial asthma
* history of peptic ulcer disease
* history of seizures
* any severe somatic disease
* current infections or chronic inflammatory diseases (e.g., rheumatic diseases, inflammatory bowel disease)
* pregnancy / breast-feeding
* class 3 obesity (body mass index of 40 or higher)
* Use of medication containing reserpine (certain antihypertensive agents), tricyclic antidepressants, bon-selective monoamine oxidase (MAO) inhibitors, antiparkinsonian drugs, sympathomimetic drugs, tetrabenazine.
Primary outcome measure(s)
The change in response bias (logb) after L-dopa/Carbidopa compared to placebo in the Probabilistic Reward Task (PRT). — All participants will be tested on two separate experimental sessions separated by an interval of 48 hours, after L-dopa/Carbidopa or placebo. The PRT, which uses a signal detection paradigm, will be used to measure response bias, the propensity to select the more rewarded response ("rich").
The change in mean gait speed [m/s] after L-dopa/Carbidopa compared to placebo in the dual task. — All participants will be tested on two separate experimental sessions separated by an interval of 48 hours, after L-dopa/Carbidopa or placebo. The dual task mean gait speed will be measured with six wearable inertial measurement units. In this dual task, participants walk at their usual speed while naming as many animals as possible.
Trial sites (1)
Facility
City
Region
Status
Klinik für Psychiatrie und Psychotherapie
Steglitz
Germany
Recruiting
More Charite University, Berlin, Germany trials in Germany
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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