BridgeMD
New treatment option for Adult ADHD
Official title EEG-MRI Imaging of Methylphenidate Effects in Adult ADHD and Attentional Symptoms in Mood Disorders
ClinicalTrials.gov ID: NCT05832489
What this study is testing
What is Methylphenidate immediate release 25mg?
Methylphenidate immediate release 25mg is an investigational medicine, being studied as a potential treatment for adult adhd.
Also referred to as MRI, EEG.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Attention Deficit Hyperactivity Disorder (ADHD) in adults is a common psychiatric disorder, with important consequences in terms of quality of life, mental health (associated disorders and poorer response to treatment), family life, risk of accidents; with a consequent cost for society. Adult ADHD is frequently associated with psychiatric co-morbidities, and notably associated with mood disorders (major depressive disorder or bipolar disorder) in about 50% of cases.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60. Healthy volunteers may be eligible.
You may be able to join if
- 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
You likely can't join if
- common to all groups
- people 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
See the full eligibility criteria
Who can join
- 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...
- 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 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...
- 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...
- Subject with or without methylphenidate treatment for Group C: healthy people control \- Subject with no psychiatric or neurological history
What rules you out
- common to all groups
- people 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...
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Strasbourg, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 60 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Strasbourg, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.