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NCT Number: NCT05909267

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

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.

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Key information

Conditions

Depressive Disorder, Major Anhedonia Behavior Behavioral Symptoms Depression Depressive Disorder Inflammation Mental Disorders Mood Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Psychomotor Disorders Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Klinik für Psychiatrie und Psychotherapie

Steglitz, 12203, Germany

Location status: Recruiting

Location contact

Woo Ri Chae, MD MSc

CONTACT

[email protected]

030 450 517625

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

L-dopa/Carbidopa

Drug

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

Placebo

Drug

Patients and healthy controls will receive one time administration of Placebo.

Primary outcomes

  1. The change in response bias (logb) after L-dopa/Carbidopa compared to placebo in the Probabilistic Reward Task (PRT).

    Time frame: 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").

  2. The change in mean gait speed [m/s] after L-dopa/Carbidopa compared to placebo in the dual task.

    Time frame: 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.

Secondary outcomes

  1. The change in choice of the hard task after L-dopa/Carbidopa compared to placebo in the Effort Expenditure for Rewards Task (EEfRT).

    Time frame: All participants will be tested on two separate experimental sessions separated by an interval of 48 hours, after L-dopa/Carbidopa or placebo.

    The EEfRT, a widely used, multi-trial task in which participants are given an opportunity on each trial to choose between two different task difficulty levels in order to obtain monetary rewards, will be used as an objective measure of reward motivation. The EEfRT is reported as the percent of high effort (hard) trials selected. A higher percentage reflects higher motivation for effort expenditure.

  2. The change in movement time [ms] after L-dopa/Carbidopa compared to placebo in the Reaction Time Task (RTI).

    Time frame: All participants will be tested on two separate experimental sessions separated by an interval of 48 hours, after L-dopa/Carbidopa or placebo.

    The RTI from the Cambridge Neuropsychological Test Automated Battery (CANTAB) will be used to assess movement time, which is the time taken to touch the stimulus on the computer screen after the press pad had been released.

  3. The change in risk propensity after L-dopa/Carbidopa compared to placebo in the Risky Decision-Making Task.

    Time frame: All participants will be tested on two separate experimental sessions separated by an interval of 48 hours, after L-dopa/Carbidopa or placebo.

    In the Risky Decision-Making Task, participants have to make choices between a risky option and a safe alternative. Risk Propensity, the proportion of risk-taking trials, will be a secondary outcome.

  4. Response bias (logb) in the PRT

    Time frame: After administration of placebo on Day 2 or Day 3.

  5. Mean gait speed [m/s] in the dual task

    Time frame: After administration of placebo on Day 2 or Day 3.

  6. Choice of the hard task in the EEfRT

    Time frame: After administration of placebo on Day 2 or Day 3.

  7. Movement time [ms] in the RTI

    Time frame: After administration of placebo on Day 2 or Day 3.

Other outcomes

  1. The change in speed and accuracy after L-dopa/Carbidopa compared to placebo in the Rapid Visual Information Processing Task (RVP).

    Time frame: All participants will be tested on two separate experimental sessions separated by an interval of 48 hours, after L-dopa/Carbidopa or placebo.

    The RVP from the Cambridge Neuropsychological Test Automated Battery (CANTAB) will be used to assess performance speed (mean latency for correct responses) and accuracy (target sensitivity score).

  2. Risk propensity in the Risky Decision-Making Task

    Time frame: At baseline on Day 1.

Study contacts

Contact information is provided by the study sponsor or research team.

Woo Ri Chae, MD MSc

CONTACT

[email protected]

+49 30 450 517625

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Collaborators

  • Dr. Ulrike Grittner
  • Motognosis GmbH
  • Prof. Dr. Soyoung Q Park
  • Prof. Dr. Stefan M. Gold

Registry information

Official study title

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

Acronym: MOTIVADE

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jun 18, 2023
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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