NCT05909267Recruiting
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.
Source: ClinicalTrials.gov · Last updated 18 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 165 (estimated)
- First submitted
- 31 May 2023
- Start date
- 26 Jul 2023
- Primary completion date
- Jul 2026
- Lead sponsor
- Charite University, Berlin, Germany
- Diseases
- Depression
- NCT number
- NCT05909267
What you commit to
- Study type: Interventional
- Planned participants: 165
- From 26 Jul 2023 to the primary completion date, Jul 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of medication containing reserpine (certain antihypertensive agents), tricyclic antidepressants, bon-selective monoamine oxidase (MAO) inhibitors, antiparkinsonian drugs, sympathomimetic drugs, tetrabenazine.
Other illness
- 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
- 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)
Other
- narrow-angle or wide-angle glaucoma
- bronchial asthma
- pregnancy / breast-feeding
- class 3 obesity (body mass index of 40 or higher)
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Klinik für Psychiatrie und Psychotherapie Coordinator of this site? Confirm its status | Steglitz | Germany | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.