Back to resultsDopamine Modulation of Motivation and Motor Function in Major Depression & Inflammation (MOTIVADE)
Primary Purpose
Depressive Disorder, Major
Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
L-dopa/Carbidopa
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Depressive Disorder, Major focused on measuring depression, inflammation, anhedonia, psychomotor retardation
Eligibility Criteria
Inclusion Criteria: For patients with major depressive disorder: diagnosis of major depressive disorder according to DSM-5 C-reactive protein (CRP): > 3 mg/l or ≤ 1 mg/l 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.
Sites / Locations
- Klinik für Psychiatrie und PsychotherapieRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
L-dopa/Carbidopa followed by placebo
Placebo followed by L-dopa/Carbidopa
Arm Description
Participants will receive first L-dopa/Carbidopa (100/25 mg), and then placebo.
Participants will receive first placebo, and then L-dopa/Carbidopa (100/25 mg).
Outcomes
Primary Outcome Measures
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").
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.
Secondary Outcome Measures
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.
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.
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.
Response bias (logb) in the PRT
Mean gait speed [m/s] in the dual task
Choice of the hard task in the EEfRT
Movement time [ms] in the RTI
Full Information
NCT ID
NCT05909267
First Posted
May 31, 2023
Last Updated
August 7, 2023
Sponsor
Charite University, Berlin, Germany
Collaborators
Prof. Dr. Stefan M. Gold, Prof. Dr. Soyoung Q Park, Dr. Ulrike Grittner, Motognosis GmbH
1. Study Identification
Unique Protocol Identification Number
NCT05909267
Brief Title
Dopamine Modulation of Motivation and Motor Function in Major Depression & Inflammation
Acronym
MOTIVADE
Official Title
Effects of Pharmacological Dopamine Modulation on Motivation and Motor Function in Major Depression Characterized by Low-grade Inflammation.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 26, 2023 (Actual)
Primary Completion Date
October 2025 (Anticipated)
Study Completion Date
October 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany
Collaborators
Prof. Dr. Stefan M. Gold, Prof. Dr. Soyoung Q Park, Dr. Ulrike Grittner, Motognosis GmbH
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder, Major
Keywords
depression, inflammation, anhedonia, psychomotor retardation
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
165 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
L-dopa/Carbidopa followed by placebo
Arm Type
Experimental
Arm Description
Participants will receive first L-dopa/Carbidopa (100/25 mg), and then placebo.
Arm Title
Placebo followed by L-dopa/Carbidopa
Arm Type
Experimental
Arm Description
Participants will receive first placebo, and then L-dopa/Carbidopa (100/25 mg).
Intervention Type
Drug
Intervention Name(s)
L-dopa/Carbidopa
Intervention Description
Patients and healthy controls will receive one time administration of L-dopa/Carbidopa (100/25 mg).
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Patients and healthy controls will receive one time administration of Placebo.
Primary Outcome Measure Information:
Title
The change in response bias (logb) after L-dopa/Carbidopa compared to placebo in the Probabilistic Reward Task (PRT).
Description
The PRT, which uses a signal detection paradigm, will be used to measure response bias, the propensity to select the more rewarded response ("rich").
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.
Title
The change in mean gait speed [m/s] after L-dopa/Carbidopa compared to placebo in the dual task.
Description
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.
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.
Secondary Outcome Measure Information:
Title
The change in choice of the hard task after L-dopa/Carbidopa compared to placebo in the Effort Expenditure for Rewards Task (EEfRT).
Description
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.
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.
Title
The change in movement time [ms] after L-dopa/Carbidopa compared to placebo in the Reaction Time Task (RTI).
Description
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.
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.
Title
The change in risk propensity after L-dopa/Carbidopa compared to placebo in the Risky Decision-Making Task.
Description
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.
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.
Title
Response bias (logb) in the PRT
Time Frame
After administration of placebo on Day 2 or Day 3.
Title
Mean gait speed [m/s] in the dual task
Time Frame
After administration of placebo on Day 2 or Day 3.
Title
Choice of the hard task in the EEfRT
Time Frame
After administration of placebo on Day 2 or Day 3.
Title
Movement time [ms] in the RTI
Time Frame
After administration of placebo on Day 2 or Day 3.
Other Pre-specified Outcome Measures:
Title
The change in speed and accuracy after L-dopa/Carbidopa compared to placebo in the Rapid Visual Information Processing Task (RVP).
Description
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).
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.
Title
Risk propensity in the Risky Decision-Making Task
Time Frame
At baseline on Day 1.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
For patients with major depressive disorder:
diagnosis of major depressive disorder according to DSM-5
C-reactive protein (CRP): > 3 mg/l or ≤ 1 mg/l
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Woo Ri Chae, MD MSc
Phone
+49 30 450 517625
Email
woo-ri.chae@charite.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Woo Ri Chae, MD MSc
Organizational Affiliation
Charite University, Berlin, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Klinik für Psychiatrie und Psychotherapie
City
Berlin-Steglitz
ZIP/Postal Code
12203
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Woo Ri Chae, MD MSc
Phone
030 450 517625
Email
motivade-studie@charite.de
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Dopamine Modulation of Motivation and Motor Function in Major Depression & Inflammation
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