EEG-MRI Study of the Effect of Methylphenidate on Neural Mechanisms in Adult Patients With ADHD With or Without Mood Disorders: a Randomized Controlled Trial Versus Placebo

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• Common criteria for all groups - Subject with a contraindication to methylphenidate: * hypersensitivity to the active substance, * glaucoma * pheochromocytoma, * treatment with other indirect sympathomimetics or alpha sympathomimetics (oral and/or nasal), irreversible MAOIs * Hyperthyroidism or thyrotoxicosis, * Pre-existing cardiovascular disorders including severe hypertension, XML File Identifier: 0Vmd7NrSRK8JeP+9ISLPaO9Oq+U= Page 12/26 heart failure, arterial occlusive disease, angina pectoris, congenital heart disease with hemodynamic impact, cardiomyopathy, myocardial infarction, arrhythmias and potentially life-threatening channelopathies (disorders caused by ion channel dysfunction), * Pre-existing cerebrovascular disorders, cerebral aneurysms, vascular abnormalities including vasculitis or stroke, * wheat allergy (other than celiac disease) - Unstabilized psychiatric disorders: severe depression, anorexia nervosa or anorexic disorder, suicidal tendencies, psychotic symptoms, severe mood disorders, mania, schizophrenia, psychopathic or borderline personality disorder - Family history of ventricular arrhythmia, sudden death, particularly of cardiac origin, or unexplained death - Subjects with a contraindication to MRI: presence of a non-removable ferromagnetic body, prosthesis, pacemaker, medication delivered by an implanted pump, vascular clip or stent, heart valve or ventricular bypass - History that may affect brain anatomy or be related to an abnormality (neonatal distress, neurosurgical operation, comitiveness, stroke, head injury with loss of consciousness of more than 15 minutes and mental retardation) - History that may affect brain function (general anesthesia or electroconvulsive therapy within 3 months prior to inclusion) - Substance use disorder, according to DSM-5 criteria (excluding tobacco) - Pregnant women or, in women of childbearing age and capacity (not infertile), lack of effective contraception - Subjects participating in other research involving an investigational product - Nursing women - Serious or unstabilized somatic pathology. - Subject deprived of liberty, or under forced care - Incapacitated subject (subject to a legal protection measure: curatorship, guardianship, future protection mandate, family habilitation) - Impossibility to give the subject informed information (subject in an emergency situation, difficulties in understanding the subject, ...) - Subject in a period of exclusion defined by another protocol in progress
• 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.
• 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.
• Group C: healthy subjects control - Taking any psychotropic medication (seasonal allergy treatments permitted)