Motivation and Methylphenidate (MBB_MPH)

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

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 Overview

• Status: Unknown
• Conditions: Impulsive Behavior; Motivation; Apathy
• Intervention / Treatment: Drug: Ritalin 10Mg Tablet

• Study Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• France
  • Paris, France, 75013
    • Centre d'investigation clinique, Institut du Cerveau et de la Moelle
    • Contact: Jean-Christophe CORVOL, MD; Phone Number: +33142165773; Email: jean-christophe.corvol@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: methylphenidate	Drug: Ritalin 10Mg Tablet; ingestion of an oral single-dose
Placebo Comparator: inactive pill	Drug: Ritalin 10Mg Tablet; ingestion of an oral single-dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Institut National de la Santé Et de la Recherche Médicale, France

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2017
• Primary Completion (Anticipated): September 30, 2017
• Study Completion (Anticipated): September 30, 2018

Study Registration Dates

• First Submitted: May 31, 2017
• First Submitted That Met QC Criteria: June 14, 2017
• First Posted (Actual): June 19, 2017

Study Record Updates

• Last Update Posted (Actual): June 19, 2017
• Last Update Submitted That Met QC Criteria: June 14, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Impulsive Behavior; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Dopamine Agents; Dopamine Uptake Inhibitors; Central Nervous System Stimulants; Methylphenidate
• Other Study ID Numbers: C13-08

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No