Motivation and Methylphenidate (MBB_MPH)

Institut National de la Santé Et de la Recherche Médicale, France

Status and phase: Completed; Early Phase 1

Conditions: Motivation; Apathy; Impulsive Behavior

Treatments: Drug: Ritalin 10Mg Tablet; Drug: Placebo Oral Tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT03190681

C13-08

Details and patient eligibility

About

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.

Enrollment: 35 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts 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)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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35 participants in 2 patient groups

methylphenidate then placebo

Experimental group

Treatment:

Drug: Placebo Oral Tablet

Drug: Ritalin 10Mg Tablet

placebo then methylphenidate

Experimental group

Treatment:

Drug: Placebo Oral Tablet

Drug: Ritalin 10Mg Tablet