Can a single dose of ADHD medication reveal how it works in the brain?
NCT ID NCT05832489
First seen Aug 21, 2026 · Last updated Aug 21, 2026
Summary
This trial investigates whether methylphenidate, a common ADHD medication, affects brain circuits differently in adults with ADHD alone, those with ADHD plus mood disorders, and healthy individuals. Using EEG and MRI, researchers will compare brain activity after a single dose of methylphenidate versus placebo. The goal is to understand if the drug works through the same neural mechanisms in different patient groups, which could inform more personalized treatment approaches.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- methylphenidate (immediate release 25 mg)
- What this could lead to
- If successful, this could reveal whether methylphenidate works the same way in the brain for adults with ADHD alone and those with ADHD plus mood disorders, potentially guiding better treatment choices.
- What could go wrong
- This is a single-dose study with brain imaging, not a long-term treatment trial. Results may not predict real-world effectiveness, and the small sample size limits generalizability.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 80 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2024
- Expected to finish
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May 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 60 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion criteria common to all groups: * Subject (male or female) aged 18 to 60 years old * Subject affiliated to a social protection health insurance scheme * Subject capable of understanding the objectives and risks of the research and of providing dated and signed informed consent * Subject having been informed of the results of the prior medical examination * For a woman of childbearing age: negative blood pregnancy test and effective contraception throughout the study (intrauterine device, sterilization, estro-progestogen or progestogen per os, injectable or in the form of an implant or ring) and refusal to perform a pregnancy test before each MRI) Inclusion criteria for Group A: ADHD patients without associated mood disorder (ADHD-P) * Diagnosis of ADHD according to DSM-5 (in particular criterion B: presence of symptoms before the age of 12 years) NB: the diagnosis was not necessarily made at this age. * Subject with or without methylphenidate treatment Inclusion criteria for Group B: Patients with attention deficit disorder due to/accentuated by mood disorders (ADHD-MD) * Association of ADHD symptoms with attentional disorders according to the combination of the following criteria : * Diagnosis of Recurrent Depressive Disorder or Bipolar Disorder according to DSM-5 * Currently euthymic, i.e. a QIDS-16SC depression score \< 6 and a YRMS mania score \< 6, and clinically stabilized for at least 6 weeks prior to inclusion (stable and off-acute treatment). NB: for ISQ item 10 (concentration/decision making, score decision making only) * DSM-5 Adult ADHD Criteria A (at least 5 symptoms of inattention and/or hyperactivity/impulsivity) * Absence of Criterion D during childhood, adolescence and before mood disorders (i.e., no significant impact with reduced quality of social, academic or occupational functioning) * Presence of Criterion D at present (symptoms have a significant impact with a reduction in the quality of social, academic or professional functioning) * Subject with or without approved mood disorder treatment: Mood stabilizers (lithium, valproate, lamotrigine); antidepressants (SSRIs, IRSNa ≤60mg/j of venlafaxine and ≤60mg/j of duloxetine); benzodiazepines in stable doses for more than a month. * Subject with or without methylphenidate treatment Inclusion criteria for Group C: healthy subjects control \- Subject with no psychiatric or neurological history Exclusion criteria common to all groups * Subjects with contraindication to methylphenidate : * hypersensitivity to the active substance, * glaucoma, * pheochromocytoma, * treatment with other indirect sympathomimetics or alpha sympathomimetics (oral and/or nasal routes), irreversible MAOIs * Hyperthyroidism or thyrotoxicosis, * Pre-existing cardiovascular disorders including severe hypertension, heart failure, occlusive arterial disease, angina pectoris, congenital heart disease with hemodynamic impact, cardiomyopathy, myocardial infarction, arrhythmias and potentially life-threatening ductopathies (disorders caused by ion channel dysfunction), * Pre-existing cerebrovascular disorders, brain aneurysms, vascular abnormalities including vasculitis or stroke, * wheat allergy (other than celiac disease) * Diagnosis or history of severe depression, anorexia nervosa or anorexic disorder, suicidal tendencies, psychotic symptoms, severe mood disorders, mania, schizophrenia, psychopathic or borderline personality disorder. * Diagnosis or history of episodic and severe (type 1) (and poorly controlled) bipolar (affective) disorder. * Subjectis with contraindication to performing an MRI: presence of non-removable ferromagnetic body, prosthesis, pacemaker, medication delivered by an implanted pump, vascular clip or stent, heart valve or ventricular shunt * History that may affect brain anatomy or be related to an abnormality (neonatal suffering, neurosurgical operation, comitiality, stroke, head injury with unconsciousness of more than 15 minutes and mental retardation) * History that may affect brain function (general anaesthesia or ECT within 3 months prior to inclusion) * Substance Use Disorder as per DSM-5 criteria (except tobacco) * Pregnant women or, in women of childbearing age and ability (non-sterile), lack of effective contraception * Breastfeeding women * Severe or unstable somatic pathology. * Subject deprived of liberty, or in care under restraint * Subject under safeguard of justice * Incompetent subject (subject to a legal protection measure: curatorship, guardianship, future protection mandate, family habilitation) * Impossibility to give informed information about the subject (subject in an emergency situation, difficulties in understanding the subject, ...) * Subject in exclusion period defined by another protocol in progress Exclusion criteria for Group A: ADHD patients without associated mood disorder (ADHD-P) * Current Mood Disorder * History of bipolar disorder in a first-degree relative * Taking unauthorized psychotropic drugs: all antidepressants, antipsychotics, sedative antihistamines, regular hypnotics, benzodiazepines in unstable doses. Exclusion criteria for Group B: Patients with attention deficit disorder due to/accentuated by mood disorders (ADHD-MD) * Acute phase of mood disorder defined by scores a depression score in the QIDS-16SC ≥ 6 and a mania score in the YRMS ≥ 6. NB: for ISQ item 10 (concentration/decision making, score decision making only). * Use of unauthorized psychotropic drugs including antipsychotics, sedative antihistamines, high-dose IRSNa (\>150mg/d venlafaxine and \>60mg/d duloxetine), MAOIs, tricyclic antidepressants, benzodiazepines in unstable doses.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Service de Psychiatrie 2, Hôpitaux Universitaires de Strasbourg
RECRUITINGStrasbourg, 67091, France
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