Effects of Pharmacological Dopamine Modulation on Motivation and Motor Function in Major Depression Characterized by Low-grade Inflammation.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 165
- 试验地点
- 1
- 主要终点
- The change in response bias (logb) after L-dopa/Carbidopa compared to placebo in the Probabilistic Reward Task (PRT).
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
L-dopa/Carbidopa followed by placebo
Participants will receive first L-dopa/Carbidopa (100/25 mg), and then placebo.
干预措施: L-dopa/Carbidopa (Drug)
L-dopa/Carbidopa followed by placebo
Participants will receive first L-dopa/Carbidopa (100/25 mg), and then placebo.
干预措施: Placebo (Drug)
Placebo followed by L-dopa/Carbidopa
Participants will receive first placebo, and then L-dopa/Carbidopa (100/25 mg).
干预措施: L-dopa/Carbidopa (Drug)
Placebo followed by L-dopa/Carbidopa
Participants will receive first placebo, and then L-dopa/Carbidopa (100/25 mg).
干预措施: Placebo (Drug)
结局指标
主要结局
The change in response bias (logb) after L-dopa/Carbidopa compared to placebo in the Probabilistic Reward Task (PRT).
时间窗: 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.
时间窗: 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.
次要结局
- The change in movement time [ms] after L-dopa/Carbidopa compared to placebo in the Reaction Time Task (RTI).(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(After administration of placebo on Day 2 or Day 3.)
- The change in choice of the hard task after L-dopa/Carbidopa compared to placebo in the Effort Expenditure for Rewards Task (EEfRT).(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.(All participants will be tested on two separate experimental sessions separated by an interval of 48 hours, after L-dopa/Carbidopa or placebo.)
- Movement time [ms] in the RTI(After administration of placebo on Day 2 or Day 3.)
- Mean gait speed [m/s] in the dual task(After administration of placebo on Day 2 or Day 3.)
- Choice of the hard task in the EEfRT(After administration of placebo on Day 2 or Day 3.)
研究者
Woo Ri Chae, MD
Principal Investigator
Charite University, Berlin, Germany