Motivation and Methylphenidate

Early Phase 1

Completed

• Conditions: Motivation; Apathy; Impulsive Behavior
• Interventions: Drug: Ritalin 10Mg Tablet; Drug: Placebo Oral Tablet

• Registration Number: NCT03190681
• Lead Sponsor: Institut National de la Santé Et de la Recherche Médicale, France

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-05-31
• Study First Submitted QC: 2017-06-14
• Study First Posted: 2017-06-19
• Study Start: 2017-07-11
• Primary Completion: 2017-11-15
• Study Completion: 2017-11-15
• Status Verified: 2025-02
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
methylphenidate then placebo	Ritalin 10Mg Tablet	-
methylphenidate then placebo	Placebo Oral Tablet	-
placebo then methylphenidate	Ritalin 10Mg Tablet	-
placebo then methylphenidate	Placebo Oral Tablet	-

Primary Outcome Measures

Name	Time	Method
coefficient of sensitivity to reward	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 Outcome Measures

Name	Time	Method
coefficient of sensitivity to effort	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).
coefficient of sensitivity to punishment	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).
coefficient of sensitivity to delay	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).

Trial Locations

Locations (1)

Centre d'investigation clinique, Institut du Cerveau et de la Moelle; 🇫🇷 Paris, France