Motivation and Methylphenidate

Motivation Clinical Trial

— MBB_MPH  

Official title:

Etude Comparative Monocentrique, randomisée, en Cross-over, en Double Aveugle, Contre Placebo, de l'Action du méthylphénidate Sur Les paramètres Cognitifs de la Motivation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03190681
• Other study ID #: C13-08
• Status: Not yet recruiting
• Phase: Early Phase 1
• First received: May 31, 2017
• Last updated: June 14, 2017
• Start date: July 1, 2017
• Est. completion date: September 30, 2018

Study information

• Verified date: June 2017
• Source: Institut National de la Santé Et de la Recherche Médicale, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 24
• Est. completion date: September 30, 2018
• Est. primary completion date: September 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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)

Related Conditions & MeSH terms

• Apathy
• Impulsive Behavior
• Motivation

Intervention

Drug:
• Ritalin 10Mg Tablet
ingestion of an oral single-dose

Locations

Country	Name	City	State
France	Centre d'investigation clinique, Institut du Cerveau et de la Moelle	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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).	two hours after administration
Secondary	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).	two hours after administration
Secondary	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).	two hours after administration