NCT03190681CompletedEarly Phase 1
Etude Comparative Monocentrique, randomisée, en Cross-over, en Double Aveugle, Contre Placebo, de l'Action du méthylphénidate Sur Les paramètres Cognitifs de la Motivation
Institut National de la Santé Et de la Recherche Médicale, France2 sites in 1 country35 target enrollmentStarted: July 11, 2017Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Early Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 35
- Locations
- 2
- Primary Endpoint
- coefficient of sensitivity to reward
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
- •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
- •pheochromocytoma
- •gluten intolerance or hypersensitivity
- •galactosemia, glucose malabsorption syndrome, lactase deficit
- •countraindicated meds (IMAO, IMAO-A, orhtosympathomimetics, alcaloids, linezolin, enzymatic inducers, psycho-active drugs)
Arms & Interventions
placebo then Ritalin (methylphenidate)
Experimental
Intervention: Placebo Oral Tablet (Drug)
Ritalin (methylphenidate) then placebo
Experimental
Intervention: Ritalin (methylphenidate)10Mg Tablet (Drug)
Ritalin (methylphenidate) then placebo
Experimental
Intervention: Placebo Oral Tablet (Drug)
placebo then Ritalin (methylphenidate)
Experimental
Intervention: Ritalin (methylphenidate)10Mg Tablet (Drug)
Outcomes
Primary Outcomes
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).
Secondary Outcomes
- 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)
Investigators
Study Sites (2)
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