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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03190681
Other study ID # C13-08
Secondary ID
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
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