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

Официальное название

Effects of Pharmacological Dopamine Modulation on Motivation and Motor Function in Major Depression Characterized by Low-grade Inflammation.

Обзор

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.

Вмешательства

• Препарат L-dopa/Carbidopa
  Patients and healthy controls will receive one time administration of L-dopa/Carbidopa (100/25 mg).
• Препарат Placebo
  Patients and healthy controls will receive one time administration of Placebo.

Первичные конечные точки

• The change in response bias (logb) after L-dopa/Carbidopa compared to placebo in the Probabilistic Reward Task (PRT). [Срок оценки: All participants will be tested on two separate experimental sessions separated by an interval of 48 hours, after L-dopa/Carbidopa or placebo.]
• The change in mean gait speed [m/s] after L-dopa/Carbidopa compared to placebo in the dual task. [Срок оценки: All participants will be tested on two separate experimental sessions separated by an interval of 48 hours, after L-dopa/Carbidopa or placebo.]

Вторичные конечные точки (7)

• The change in choice of the hard task after L-dopa/Carbidopa compared to placebo in the Effort Expenditure for Rewards Task (EEfRT). [Срок оценки: All participants will be tested on two separate experimental sessions separated by an interval of 48 hours, after L-dopa/Carbidopa or placebo.]
• The change in movement time [ms] after L-dopa/Carbidopa compared to placebo in the Reaction Time Task (RTI). [Срок оценки: All participants will be tested on two separate experimental sessions separated by an interval of 48 hours, after L-dopa/Carbidopa or placebo.]
• The change in risk propensity after L-dopa/Carbidopa compared to placebo in the Risky Decision-Making Task. [Срок оценки: All participants will be tested on two separate experimental sessions separated by an interval of 48 hours, after L-dopa/Carbidopa or placebo.]
• Response bias (logb) in the PRT [Срок оценки: After administration of placebo on Day 2 or Day 3.]
• Mean gait speed [m/s] in the dual task [Срок оценки: After administration of placebo on Day 2 or Day 3.]
• Choice of the hard task in the EEfRT [Срок оценки: After administration of placebo on Day 2 or Day 3.]
• Movement time [ms] in the RTI [Срок оценки: After administration of placebo on Day 2 or Day 3.]

Критерии участия

Критерии включения

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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Тройное слепое

Основная цель

Фундаментальное исследование

Центры проведения

Германия · 1 центр

• Klinik für Psychiatrie und Psychotherapie — Steglitz

Идентификаторы

NCT: NCT05909267 · MOTIVADE

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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