MotivationEarly Phase 1MBB_MPHNCT03190681
Motivation and Methylphenidate
A Early Phase 1 study testing Ritalin (methylphenidate)10Mg Tablet in people with Motivation and Apathy, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Motivation, Apathy, Impulsive Behavior
- What is being tested?
- Ritalin (methylphenidate)10Mg Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteFrance
- Study dates
- 11 Jul 2017to 15 Nov 2017
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- inability to squeeze a handgrip
- smoking
- psychoactive substance consumption less than 3 weeks ago
- pregnant or breastfeeding woman
- hypersensitivity to methylphenidate
- hyperthyroidism
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- 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 locations and contacts
1 site in 1 country.
France1 site
Centre d'investigation clinique, Institut du Cerveau et de la Moelle
Paris, 75013
About this study
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
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.
- Conditions
- Motivation, Apathy, Impulsive Behavior
- Being tested
- Ritalin (methylphenidate)10Mg Tablet, Placebo Oral Tablet
- Medical subject headings
- Lethargy, Impulsive Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ritalin (methylphenidate)10Mg TabletDrug
oral ingestion of 3 tablets in a single-dose
Placebo Oral TabletDrug
oral ingestion of 3 tablets in a single-dose
| Study group | Role | What they receive |
|---|---|---|
| Ritalin (methylphenidate) then placebo | Experimental | Not described Receives: Drug: Ritalin (methylphenidate)10Mg Tablet; Drug: Placebo Oral Tablet |
| placebo then Ritalin (methylphenidate) | Experimental | Not described Receives: Drug: Ritalin (methylphenidate)10Mg Tablet; Drug: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: two hours after administration
Secondary outcomes (3)
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).
Measured: 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).
Measured: 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).
Measured: two hours after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2017
- Study start11 Jul 2017
- Primary completion15 Nov 2017
- Study completion15 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MotivationStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03190681
- Sponsor's protocol ID
- C13-08
- Acronym
- MBB_MPH
- Status last verified
- Feb 2025
- First submitted
- 31 May 2017
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03190681
- Acronym / sponsor ID
- MBB_MPH / C13-08
- Conditions
- Motivation, Apathy, Impulsive Behavior
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Study start
- 11 Jul 2017 (actual)
- Primary completion
- 15 Nov 2017 (actual)
- Study completion
- 15 Nov 2017 (actual)
- First posted
- 19 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ritalin (methylphenidate) then placebo | Experimental | Drug: Ritalin (methylphenidate)10Mg Tablet, Drug: Placebo Oral Tablet |
| placebo then Ritalin (methylphenidate) | Experimental | Drug: Ritalin (methylphenidate)10Mg Tablet, Drug: Placebo Oral Tablet |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- weight>= 50kg and <=90kg
- free and informed consent
- social security affiliation
- no chronic illness
- no previous participation to a protocol wth similar tasks
Key exclusion criteria (13 listed)
- inability to squeeze a handgrip
- smoking
- psychoactive substance consumption less than 3 weeks ago
- pregnant or breastfeeding woman
- hypersensitivity to methylphenidate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ritalin (methylphenidate)10Mg Tabletoral ingestion of 3 tablets in a single-dose | Drug | Ritalin (methylphenidate) then placebo, placebo then Ritalin (methylphenidate) |
| Placebo Oral Tabletoral ingestion of 3 tablets in a single-dose | Drug | Ritalin (methylphenidate) then placebo, placebo then Ritalin (methylphenidate) |
Primary outcome
coefficient of sensitivity to reward
Time frame: two hours after administration
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).
3 secondary outcomes
coefficient of sensitivity to effort
Time frame: two hours after administration
coefficient of sensitivity to punishment
Time frame: two hours after administration
coefficient of sensitivity to delay
Time frame: two hours after administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Ritalin (methylphenidate)10Mg Tablet in people with Motivation and Apathy, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
coefficient of sensitivity to reward (time frame: two hours after administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.