Motivation and Methylphenidate (MBB_MPH)
Etude Comparative Monocentrique, randomisée, en Cross-over, en Double Aveugle, Contre Placebo, de l'Action du méthylphénidate Sur Les paramètres Cognitifs de la Motivation
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Early Phase 1
Contacts and Locations
Study Locations
-
-
-
Paris, France, 75013
- Centre d'investigation clinique, Institut du Cerveau et de la Moelle
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- weight>= 50kg and <=90kg
- free and informed consent
- social security affiliation
- no chronic illness
- no previous participation to a protocol wth similar tasks
- no special legal status (guardianship,trusteeship)
- no personnal or familial neurologic or psychiatric background
- no contraceptive device for a reproductive woman
Exclusion Criteria:
- inability to squeeze a handgrip
- smoking
- psychoactive substance consumption less than 3 weeks ago
- pregnant or breastfeeding woman
- hypersensitivity to methylphenidate
- hyperthyroidism
- cardiovascular or cerebrovascular disease
- respiratory, hepatic or renal failure
- glaucoma
- pheochromocytoma
- gluten intolerance or hypersensitivity
- galactosemia, glucose malabsorption syndrome, lactase deficit
- countraindicated meds (IMAO, IMAO-A, orhtosympathomimetics, alcaloids, linezolin, enzymatic inducers, psycho-active drugs)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Ritalin (methylphenidate) then placebo
|
oral ingestion of 3 tablets in a single-dose
oral ingestion of 3 tablets in a single-dose
|
|
Experimental: placebo then Ritalin (methylphenidate)
|
oral ingestion of 3 tablets in a single-dose
oral ingestion of 3 tablets in a single-dose
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
coefficient of sensitivity to reward
Time Frame: two hours after administration
|
Parameter characterizing the influence of reward expectation/experience onto behavior for each individual. This parameter is estimated through the fit of computational models to behaviors recorded in a battery of motivational tasks (choice task, effort task, Learning task). |
two hours after administration
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
coefficient of sensitivity to effort
Time Frame: two hours after administration
|
Parameter characterizing the influence of effort expectation/experience onto behavior for each individual. This parameter is estimated through the fit of computational models to behaviors recorded in a battery of motivational tasks (choice task, effort task, Learning task). |
two hours after administration
|
|
coefficient of sensitivity to punishment
Time Frame: two hours after administration
|
Parameter characterizing the influence of punishment expectation/experience onto behavior for each individual. This parameter is estimated through the fit of computational models to behaviors recorded in a battery of motivational tasks (choice task, effort task, Learning task). |
two hours after administration
|
|
coefficient of sensitivity to delay
Time Frame: two hours after administration
|
Parameter characterizing the influence of delay expectation onto behavior for each individual. This parameter is estimated through the fit of computational models to behaviors recorded in a battery of motivational tasks (choice task, effort task, Learning task). |
two hours after administration
|
Collaborators and Investigators
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Nervous System Diseases
- Neurobehavioral Manifestations
- Pathological Conditions, Signs and Symptoms
- Behavior
- Signs and Symptoms
- Impulsive Behavior
- Lethargy
- Organic Chemicals
- Heterocyclic Compounds, 1-Ring
- Heterocyclic Compounds
- Carboxylic Acids
- Piperidines
- Acids, Carbocyclic
- Phenylacetates
- Methylphenidate
Other Study ID Numbers
Other Study ID Numbers
- C13-08
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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