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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

165 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-26

Study Completion Date

2025-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Dopamine Neurotransmission in Major Depression

NCT01659814

Major Depressive Disorder Anhedonia

COMPLETED

Cerebral Neuroinflammation During Major Depressive Episode

NCT03314155

Depressive Disorder

UNKNOWN NA

Cerebral and Anti-inflammatory Response Through Exercise - Mechanisms In Depressive Disorders

NCT06450704

Major Depressive Disorder Inflammatory Response

RECRUITING NA

Using Neuroimaging to Investigate Major Depressive Disorder

NCT00781677

Major Depressive Disorder Depression Anxiety

COMPLETED

Imaging Dopamine Release in Depression

NCT02033369

Major Depressive Disorder

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Depressive Disorder, Major

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

L-dopa/Carbidopa followed by placebo

Participants will receive first L-dopa/Carbidopa (100/25 mg), and then placebo.

Group Type EXPERIMENTAL

L-dopa/Carbidopa

Intervention Type DRUG

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

Placebo

Intervention Type DRUG

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

Placebo followed by L-dopa/Carbidopa

Participants will receive first placebo, and then L-dopa/Carbidopa (100/25 mg).

Group Type EXPERIMENTAL

L-dopa/Carbidopa

Intervention Type DRUG

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

Placebo

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

L-dopa/Carbidopa

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes