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New treatment option for Depressive Disorder, Major
Official title Dopamine Modulation of Motivation and Motor Function in Major Depression & Inflammation
ClinicalTrials.gov ID: NCT05909267
What this study is testing
What is L-dopa/Carbidopa?
L-dopa/Carbidopa is an investigational medicine, being studied as a potential treatment for depressive disorder, major.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65. Healthy volunteers may be eligible.
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Steglitz, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Steglitz, Germany. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.