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Motivation and Methylphenidate (MBB_MPH)

Primary Purpose

Motivation, Apathy, Impulsive Behavior

Status
Unknown status
Phase
Early Phase 1
Locations
France
Study Type
Interventional
Intervention
Ritalin 10Mg Tablet
Sponsored by
Institut National de la Santé Et de la Recherche Médicale, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Motivation

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Centre d'investigation clinique, Institut du Cerveau et de la Moelle

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

methylphenidate

inactive pill

Arm Description

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).
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).
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).

Full Information

First Posted
May 31, 2017
Last Updated
June 14, 2017
Sponsor
Institut National de la Santé Et de la Recherche Médicale, France
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1. Study Identification

Unique Protocol Identification Number
NCT03190681
Brief Title
Motivation and Methylphenidate
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2017 (Anticipated)
Primary Completion Date
September 30, 2017 (Anticipated)
Study Completion Date
September 30, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Institut National de la Santé Et de la Recherche Médicale, France

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Motivation, Apathy, Impulsive Behavior

7. Study Design

Primary Purpose
Basic Science
Study Phase
Early Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
methylphenidate
Arm Type
Experimental
Arm Title
inactive pill
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Ritalin 10Mg Tablet
Intervention Description
ingestion of an oral single-dose
Primary Outcome Measure Information:
Title
coefficient of sensitivity to reward
Description
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 Outcome Measure Information:
Title
coefficient of sensitivity to effort
Description
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
Title
coefficient of sensitivity to punishment
Description
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
Title
coefficient of sensitivity to delay
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Facility Information:
Facility Name
Centre d'investigation clinique, Institut du Cerveau et de la Moelle
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Christophe CORVOL, MD
Phone
+33142165773
Email
jean-christophe.corvol@aphp.fr

12. IPD Sharing Statement

Plan to Share IPD
No

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Motivation and Methylphenidate

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