Depressive Disorder, MajorMOTIVADENCT05909267
Dopamine Modulation of Motivation and Motor Function in Major Depression & Inflammation
A study testing L-dopa/Carbidopa in people with Depressive Disorder, Major, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Depressive Disorder, Major
- What is being tested?
- L-dopa/Carbidopa
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 165 participants
- Where
- 1 siteGermany
- Study dates
- 26 Jul 2023to Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Klinik für Psychiatrie und Psychotherapie
Steglitz, 12203
Woo Ri Chae, MD MSc, 030 450 517625, motivade-studie@charite.de
About this study
Official title: Effects of Pharmacological Dopamine Modulation on Motivation and Motor Function in Major Depression Characterized by Low-grade 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.
- Conditions
- Depressive Disorder, Major
- Being tested
- L-dopa/Carbidopa, Placebo
- Keywords
- depression, inflammation, anhedonia, psychomotor retardation
- Medical subject headings
- Depressive Disorder, Major, Depression, Inflammation, Anhedonia, Psychomotor Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-dopa/CarbidopaDrug
Patients and healthy controls will receive one time administration of L-dopa/Carbidopa (100/25 mg).
PlaceboDrug
Patients and healthy controls will receive one time administration of Placebo.
| Study group | Role | What they receive |
|---|---|---|
| L-dopa/Carbidopa followed by placebo | Experimental | Participants will receive first L-dopa/Carbidopa (100/25 mg), and then placebo. Receives: Drug: L-dopa/Carbidopa; Drug: Placebo |
| Placebo followed by L-dopa/Carbidopa | Experimental | Participants will receive first placebo, and then L-dopa/Carbidopa (100/25 mg). Receives: Drug: L-dopa/Carbidopa; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in response bias (logb) after L-dopa/Carbidopa compared to placebo in the Probabilistic Reward Task (PRT).
The PRT, which uses a signal detection paradigm, will be used to measure response bias, the propensity to select the more rewarded response ("rich").
Measured: 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.
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.
Measured: All participants will be tested on two separate experimental sessions separated by an interval of 48 hours, after L-dopa/Carbidopa or placebo.
Secondary outcomes (7)
The change in choice of the hard task after L-dopa/Carbidopa compared to placebo in the Effort Expenditure for Rewards Task (EEfRT).
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.
Measured: 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).
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.
Measured: 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.
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.
Measured: 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
Measured: After administration of placebo on Day 2 or Day 3.
Mean gait speed [m/s] in the dual task
Measured: After administration of placebo on Day 2 or Day 3.
Choice of the hard task in the EEfRT
Measured: After administration of placebo on Day 2 or Day 3.
Movement time [ms] in the RTI
Measured: After administration of placebo on Day 2 or Day 3.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start26 Jul 2023
- Primary completionJul 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive Disorder, MajorStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 165 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Prof. Dr. Stefan M. Gold, Prof. Dr. Soyoung Q Park, Dr. Ulrike Grittner, Motognosis GmbH
- Responsible party
- Principal investigator, Woo Ri Chae, MD, Charite University, Berlin, Germany
- Investigators
- Woo Ri Chae, MD MSc, Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05909267
- Sponsor's protocol ID
- MOTIVADE
- Acronym
- MOTIVADE
- Status last verified
- Mar 2026
- First submitted
- 31 May 2023
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Pharmacological Dopamine Modulation on Motivation and Motor Function in Major Depression Characterized by Low-grade Inflammation.
- ClinicalTrials.gov ID
- NCT05909267
- Acronym / sponsor ID
- MOTIVADE / MOTIVADE
- Conditions
- Depressive Disorder, Major
- Keywords
- depression, inflammation, anhedonia, psychomotor retardation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 165 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Prof. Dr. Stefan M. Gold, Prof. Dr. Soyoung Q Park, Dr. Ulrike Grittner, Motognosis GmbH
- Study start
- 26 Jul 2023 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 18 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| L-dopa/Carbidopa followed by placebo | Experimental | Drug: L-dopa/Carbidopa, Drug: PlaceboParticipants will receive first L-dopa/Carbidopa (100/25 mg), and then placebo. |
| Placebo followed by L-dopa/Carbidopa | Experimental | Drug: L-dopa/Carbidopa, Drug: PlaceboParticipants will receive first placebo, and then L-dopa/Carbidopa (100/25 mg). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- diagnosis of major depressive disorder according to DSM-5
- free of antidepressant medication
- C-reactive protein (CRP): ≤ 1 mg/l
- free of antidepressant medication
- free of any current psychiatric disorder
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| L-dopa/CarbidopaPatients and healthy controls will receive one time administration of L-dopa/Carbidopa (100/25 mg). | Drug | L-dopa/Carbidopa followed by placebo, Placebo followed by L-dopa/Carbidopa |
| PlaceboPatients and healthy controls will receive one time administration of Placebo. | Drug | L-dopa/Carbidopa followed by placebo, Placebo followed by L-dopa/Carbidopa |
Primary outcome
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").
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.
7 secondary outcomes
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 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 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.
Response bias (logb) in the PRT
Time frame: After administration of placebo on Day 2 or Day 3.
Mean gait speed [m/s] in the dual task
Time frame: After administration of placebo on Day 2 or Day 3.
Choice of the hard task in the EEfRT
Time frame: After administration of placebo on Day 2 or Day 3.
Movement time [ms] in the RTI
Time frame: After administration of placebo on Day 2 or Day 3.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Woo Ri Chae, MD MSc principal investigator
Charite University, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing L-dopa/Carbidopa in people with Depressive Disorder, Major, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Woo Ri Chae, MD MSc (+49 30 450 517625, woo-ri.chae@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.