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
1 other identifier
interventional
35
1 country
1
Brief Summary
The purpose of this study is to evaluate the impact of methylphenidate, a mixed dopaminergic and noradrenergic agent, onto the different components of motivation: decision-making, effort allocation and instrumental learning.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for early_phase_1
Started Jul 2017
Shorter than P25 for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 31, 2017
CompletedFirst Posted
Study publicly available on registry
June 19, 2017
CompletedStudy Start
First participant enrolled
July 11, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 15, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
November 15, 2017
CompletedApril 24, 2026
February 1, 2025
4 months
May 31, 2017
April 21, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
coefficient of sensitivity to reward
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 Outcomes (3)
coefficient of sensitivity to effort
two hours after administration
coefficient of sensitivity to punishment
two hours after administration
coefficient of sensitivity to delay
two hours after administration
Study Arms (2)
Ritalin (methylphenidate) then placebo
EXPERIMENTALplacebo then Ritalin (methylphenidate)
EXPERIMENTALInterventions
oral ingestion of 3 tablets in a single-dose
oral ingestion of 3 tablets in a single-dose
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre d'investigation clinique, Institut du Cerveau et de la Moelle
Paris, 75013, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 31, 2017
First Posted
June 19, 2017
Study Start
July 11, 2017
Primary Completion
November 15, 2017
Study Completion
November 15, 2017
Last Updated
April 24, 2026
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will not share