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CompletedNCT03190681MBB_MPHUpdated Apr 24, 2026

Motivation and Methylphenidate

An Early Phase 1 interventional study of Ritalin (methylphenidate)10Mg Tablet and Placebo Oral Tablet in Motivation, Apathy and Impulsive Behavior, sponsored by Institut National de la Santé Et de la Recherche Médicale, France. Completed at 1 site in France. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-24.

Sponsored by Institut National de la Santé Et de la Recherche Médicale, France · Early Phase 1, Interventional, and Basic science

Phase
Early Phase 1
Study type
Interventional
Enrollment
35
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Motivation
  • Apathy
  • Impulsive Behavior
03

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
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

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)
04

Study design

Phase
Early Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
35 participants (actual)

Study arms

  • Experimental
    Ritalin (methylphenidate) then placebo

    Drug: Ritalin (methylphenidate)10Mg Tablet · Drug: Placebo Oral Tablet

  • Experimental
    placebo then Ritalin (methylphenidate)

    Drug: Ritalin (methylphenidate)10Mg Tablet · Drug: Placebo Oral Tablet

Interventions

  • DrugRitalin (methylphenidate)10Mg Tablet

    oral ingestion of 3 tablets in a single-dose

  • DrugPlacebo Oral Tablet

    oral ingestion of 3 tablets in a single-dose

05

What researchers measure

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).

    Time frame: two hours after administration

Secondary outcomes

  1. coefficient of sensitivity to effort

    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).

    Time frame: two hours after administration

  2. coefficient of sensitivity to punishment

    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).

    Time frame: two hours after administration

  3. coefficient of sensitivity to delay

    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).

    Time frame: two hours after administration

06

Study locations

1 site
  • Centre d'investigation clinique, Institut du Cerveau et de la Moelle
    Paris, 75013, France
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03190681
Lead sponsor
Institut National de la Santé Et de la Recherche Médicale, France
Responsible party
Sponsor
First posted
Jun 19, 2017
Start date
Jul 11, 2017
Primary completion
Nov 15, 2017
Completion
Nov 15, 2017
Last update
Apr 24, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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