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

Study acronym: MOTIVADE
StatusRecruiting
PhaseNot applicable
Started2023-07-26
View on ClinicalTrials.gov ↗
Record status
This record was last updated March 18, 2026 (before its estimated July 2026 completion). Its status may not reflect the trial's current state.

Amendment history

2026-03-16
minor
Study Status v3
Primary completion date2025-10→2026-07
Completion date2025-10→2026-07
2024-07-01
minor
Study Status, Sponsor/Collaborators, Eligibility v2
Eligibility criteria-47 characters
[...] : diagnosis of major depressive disorder according to DSM-5 C-reactive protein (CRP): > 3 mg/l or ≤ 1 mg/l free of antidepressant medication For healthy participants: [...]
2023-08-07
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2023-06→confirmed 2023-07-26
Study sites0→1
2023-06-11
minor
Original filing
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.
Trial Details
NCT Number NCT05909267
Lead Sponsor Charite University, Berlin, Germany
Collaborators: Prof. Dr. Stefan M. Gold, Prof. Dr. Soyoung Q Park, Dr. Ulrike Grittner, Motognosis GmbH
Conditions Depressive Disorder, Major
Enrollment 165 participants
Start Date 2023-07-26
Primary Completion 2026-07 (estimated)
Study Completion 2026-07 (estimated)
Updated on ClinicalTrials.gov 2026-03-18