Adult ADHDPhase 3ImAteM-TDANCT05832489
EEG-MRI Imaging of Methylphenidate Effects in Adult ADHD and Attentional Symptoms in Mood Disorders
A Phase 3 study testing Methylphenidate immediate release 25mg in people with Adult ADHD and Adult-onset ADHD With Mood Disorder, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Adult ADHD, Adult-onset ADHD With Mood Disorder
- What is being tested?
- Methylphenidate immediate release 25mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 26 Feb 2024to May 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Show all 18Show fewer
- 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
- Subject with no psychiatric or neurological history
Who cannot join
- 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,
Show all 30Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Service de Psychiatrie 2, Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091
Sébastien WEIBEL, MD, 33388115157, sebastien.weibel@chru-strasbourg.fr
Sébastien WEIBEL, MD
About this study
Official title: 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
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.
Read more
The diagnosis of ADHD in adults is made in patients with an attentional complaint (pure ADHD or ADHD-P), but also very often in the management of a comorbid mood disorder (ADHD associated with mood disorder, or ADHD-MD). In this case, the ADHD had no impact during childhood and adolescence.
Medication management is well established for ADHD-P, and medication is based on methylphenidate, which has a rapid and significant effect on attentional symptoms and impulsivity. However, in the case of ADHD-HD, there is little evidence of treatment efficacy and the mechanisms of action of methylphenidate at the brain level are poorly understood.
The aim of the study is to determine the neural mechanisms of the effect of methylphenidate, using functional MRI and EEG, in ADHD-P and ADHD-HD patients, and to compare them to healthy subjects. A single dose allows us to observe effects that are then persistent with repeated doses. The aim is to determine, by means of a biomarker, whether methylphenidate treatment responds to the same mechanisms in the different groups and would be relevant in ADHD-P as in ADHD-HD.
Main objective:
To determine whether methylphenidate impacts differently on brain circuits associated with cognitive functions in the two clinical populations studied (adult ADHD patients and patients with post mood disorder attentional deficit) and in comparison to controls.
Secondary objectives:
- To determine the effect of methylphenidate on baseline brain flow in the two clinical populations and in controls (healthy subjects).
- To determine whether methylphenidate has a different impact on cognitive performance in the two clinical populations studied and in comparison to controls (healthy subjects).
- To confirm the effect of methylphenidate on the maintenance of cortical arousal.
- To distinguish the brain networks impacted by methylphenidate (maintenance of attention or inhibition) with MRI and EEG.
Read the detailed description
It is a cross-over, randomized, controlled, double-blind, study. 3 groups of 20 subjects are constituted: A: adult patients with ADHD (ADHD-P) B: patients with attention deficit due to/emphasized by mood disorders (ADHD-HD) C: healthy control population
During the inclusion visit the subjects fill in self-questionnaires (ASRS, WURS, WRAADDS, WFIRFS, TEMPS-A, BDI, BAI, RCTQ, mind-wandering). A 45-minute neuropsychological assessment will be carried out by a neuropsychologist, followed by training in the cognitive tasks used during the experimental sessions.
During imaging session 1 (3 to 60 days from inclusion):
Patients usually taking methylphenidate will discontinue methylphenidate treatment two days the imaging session.
Subject takes treatment (or placebo) 30-60 minutes before MRI. The MRI is performed at rest and associated with cognitive tasks (SART) (65 minutes duration). EEG is performed after in combination with a cognitive task (SART) (duration 40 minutes). Finally subjects complete self-questionnaires.
During imaging session 2 (14 to 90 days from inclusion): the same procedure is done again.
Patients usually taking methylphenidate will discontinue methylphenidate treatment two days before the session.
Subject takes placebo (if treatment during imaging session 1) or treatment (if placebo during imaging session 1) 30-60 minutes before MRI. MRI and EEG procedure are the same.
fMRI imaging includes rest and imaging during SART task (Go-NoGo), using BOLD and ASL sequences. EEG is performed during SART task.
- Conditions
- Adult ADHD, Adult-onset ADHD With Mood Disorder
- Being tested
- Placebo, Methylphenidate immediate release 25mg
- Keywords
- Adult ADHD, Sustained attention, fMRI, EEG, Pharmacoimaging, Methylphenidate
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Also called MRI, EEG
Patients will have 2 imaging sessions (MRI and EEG) after either:
- methylphenidate immediate release 25 mg
- placebo in a cross-over design. The two imaging sessions will be separated by 11 to 87 days.
Methylphenidate immediate release 25mgDrug
Also called MRI, EEG
Patients will have 2 imaging sessions (MRI and EEG) after either:
- methylphenidate immediate release 25 mg
- placebo in a cross-over design. The two imaging sessions will be separated by 11 to 87 days.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Adult patients with ADHD (ADHD-P) receive a placebo or 25 mg of methylphenidate 45min before the first and second imaging sessions (MRI+EEG) Receives: Drug: Placebo; Drug: Methylphenidate immediate release 25mg |
| Group B | Experimental | Adult patients with attention deficit due to/emphasized by mood disorders (ADHD-HD) receive a placebo or 25 mg of methylphenidate 45min before the first and second imaging sessions (MRI+EEG) Receives: Drug: Placebo; Drug: Methylphenidate immediate release 25mg |
| Group C | Experimental | Adult Healthy controls receive a placebo or 25 mg of methylphenidate 45min before the first and second imaging sessions (MRI+EEG) Receives: Drug: Placebo; Drug: Methylphenidate immediate release 25mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of methylphenidate on the task vs. rest activation differential (treatment x group interaction) in a region defined by its involvement in the cognitive task and its responsiveness to methylphenidate.
Changes in brain activations from J3-J600 to J14-J90 (MRI) in ADHD patients (ADHD-P and ADHD-HD), compared to healthy subjects(ADHD-P and ADHD-HD), compared to healthy subjects] ROI (Region of Interest) analysis to maximize power.
Measured: 2 hours after intake of methylphenidate or placebo
Secondary outcomes (5)
Decrease in rCBF (regional Cerebral Blood Flow) in the methylphenidate vs. placebo condition, in the different groups (group x treatment interaction).
Measured: 2 hours after intake of methylphenidate or placebo
Improved cognitive performance in sustained attention and inhibition tasks (SART : number of errors) following methylphenidate administration, in the different groups.
Measured: 2 hours after intake of methylphenidate or placebo
EEG spectrum power in the low frequencies (proportion of delta power (1-4Hz) and theta power EEG bands (4-8Hz)) in the methylphenidate vs. placebo condition
Measured: 3 hours after intake of methylphenidate or placebo
MRI: Interaction group x treatment x task on brain activation related to sustained attention and inhibition corresponding to each of these tasks.
Measured: 2 hours after intake of methylphenidate or placebo
EEG evoked potentials: Interaction group x treatment x task on the amplitude of the P300 wave related to sustained attention (P300b) and related to inhibition (P300a) corresponding to each of these tasks.
Measured: 3 hours after intake of methylphenidate or placebo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2023
- Study start26 Feb 2024
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult ADHDStudies of the same condition, open and under way.
- 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
- Phase 3
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sébastien WEIBEL, MD, Principal investigator, Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05832489
- Sponsor's protocol ID
- 7347
- Acronym
- ImAteM-TDA
- Status last verified
- Aug 2026
- First submitted
- 7 Jul 2022
- Last updated
- 21 Aug 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 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05832489
- Acronym / sponsor ID
- ImAteM-TDA / 7347
- Conditions
- Adult ADHD, Adult-onset ADHD With Mood Disorder
- Keywords
- Adult ADHD, Sustained attention, fMRI, EEG, Pharmacoimaging, Methylphenidate
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 26 Feb 2024 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 27 Apr 2023 (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.
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.
The diagnosis of ADHD in adults is made in patients with an attentional complaint (pure ADHD or ADHD-P), but also very often in the management of a comorbid mood disorder (ADHD associated with mood disorder, or ADHD-MD). In this case, the ADHD had no impact during childhood and adolescence.
Medication management is well established for ADHD-P, and medication is based on methylphenidate, which has a rapid and significant effect on attentional symptoms and impulsivity. However, in the case of ADHD-HD, there is little evidence of treatment efficacy and the mechanisms of action of methylphenidate at the brain level are poorly understood.
The aim of the study is to determine the neural mechanisms of the effect of methylphenidate, using functional MRI and EEG, in ADHD-P and ADHD-HD patients, and to compare them to healthy subjects. A single dose allows us to observe effects that are then persistent with repeated doses. The aim is to determine, by means of a biomarker, whether methylphenidate treatment responds to the same mechanisms in the different groups and would be relevant in ADHD-P as in ADHD-HD.
Main objective:
To determine whether methylphenidate impacts differently on brain circuits associated with cognitive functions in the two clinical populations studied (adult ADHD patients and patients with post mood disorder attentional deficit) and in comparison to controls.
Secondary objectives:
- To determine the effect of methylphenidate on baseline brain flow in the two clinical populations and in controls (healthy subjects).
- To determine whether methylphenidate has a different impact on cognitive performance in the two clinical populations studied and in comparison to controls (healthy subjects).
- To confirm the effect of methylphenidate on the maintenance of cortical arousal.
- To distinguish the brain networks impacted by methylphenidate (maintenance of attention or inhibition) with MRI and EEG.
Detailed description
It is a cross-over, randomized, controlled, double-blind, study. 3 groups of 20 subjects are constituted: A: adult patients with ADHD (ADHD-P) B: patients with attention deficit due to/emphasized by mood disorders (ADHD-HD) C: healthy control population
During the inclusion visit the subjects fill in self-questionnaires (ASRS, WURS, WRAADDS, WFIRFS, TEMPS-A, BDI, BAI, RCTQ, mind-wandering). A 45-minute neuropsychological assessment will be carried out by a neuropsychologist, followed by training in the cognitive tasks used during the experimental sessions.
During imaging session 1 (3 to 60 days from inclusion):
Patients usually taking methylphenidate will discontinue methylphenidate treatment two days the imaging session.
Subject takes treatment (or placebo) 30-60 minutes before MRI. The MRI is performed at rest and associated with cognitive tasks (SART) (65 minutes duration). EEG is performed after in combination with a cognitive task (SART) (duration 40 minutes). Finally subjects complete self-questionnaires.
During imaging session 2 (14 to 90 days from inclusion): the same procedure is done again.
Patients usually taking methylphenidate will discontinue methylphenidate treatment two days before the session.
Subject takes placebo (if treatment during imaging session 1) or treatment (if placebo during imaging session 1) 30-60 minutes before MRI. MRI and EEG procedure are the same.
fMRI imaging includes rest and imaging during SART task (Go-NoGo), using BOLD and ASL sequences. EEG is performed during SART task.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: Placebo, Drug: Methylphenidate immediate release 25mgAdult patients with ADHD (ADHD-P) receive a placebo or 25 mg of methylphenidate 45min before the first and second imaging sessions (MRI+EEG) |
| Group B | Experimental | Drug: Placebo, Drug: Methylphenidate immediate release 25mgAdult patients with attention deficit due to/emphasized by mood disorders (ADHD-HD) receive a placebo or 25 mg of methylphenidate 45min before the first and second imaging sessions (MRI+EEG) |
| Group C | Experimental | Drug: Placebo, Drug: Methylphenidate immediate release 25mgAdult Healthy controls receive a placebo or 25 mg of methylphenidate 45min before the first and second imaging sessions (MRI+EEG) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (18 listed)
- 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)
Key exclusion criteria (30 listed)
- Subjects with contraindication to methylphenidate :
- 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)
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 |
|---|---|---|
| PlaceboAlso: MRI, EEGPatients will have 2 imaging sessions (MRI and EEG) after either: * methylphenidate immediate release 25 mg * placebo in a cross-over design. The two imaging sessions will be separated by 11 to 87 days. | Drug | Group A, Group B, Group C |
| Methylphenidate immediate release 25mgAlso: MRI, EEGPatients will have 2 imaging sessions (MRI and EEG) after either: * methylphenidate immediate release 25 mg * placebo in a cross-over design. The two imaging sessions will be separated by 11 to 87 days. | Drug | Group A, Group B, Group C |
Primary outcome
Effect of methylphenidate on the task vs. rest activation differential (treatment x group interaction) in a region defined by its involvement in the cognitive task and its responsiveness to methylphenidate.
Time frame: 2 hours after intake of methylphenidate or placebo
Changes in brain activations from J3-J600 to J14-J90 (MRI) in ADHD patients (ADHD-P and ADHD-HD), compared to healthy subjects(ADHD-P and ADHD-HD), compared to healthy subjects] ROI (Region of Interest) analysis to maximize power.
5 secondary outcomes
Decrease in rCBF (regional Cerebral Blood Flow) in the methylphenidate vs. placebo condition, in the different groups (group x treatment interaction).
Time frame: 2 hours after intake of methylphenidate or placebo
Improved cognitive performance in sustained attention and inhibition tasks (SART : number of errors) following methylphenidate administration, in the different groups.
Time frame: 2 hours after intake of methylphenidate or placebo
EEG spectrum power in the low frequencies (proportion of delta power (1-4Hz) and theta power EEG bands (4-8Hz)) in the methylphenidate vs. placebo condition
Time frame: 3 hours after intake of methylphenidate or placebo
MRI: Interaction group x treatment x task on brain activation related to sustained attention and inhibition corresponding to each of these tasks.
Time frame: 2 hours after intake of methylphenidate or placebo
EEG evoked potentials: Interaction group x treatment x task on the amplitude of the P300 wave related to sustained attention (P300b) and related to inhibition (P300a) corresponding to each of these tasks.
Time frame: 3 hours after intake of methylphenidate or placebo
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 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.
Sébastien WEIBEL, MD principal investigator
Hôpitaux Universitaires de Strasbourg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Methylphenidate immediate release 25mg in people with Adult ADHD and Adult-onset ADHD With Mood Disorder, run by University Hospital, Strasbourg, 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 18 inclusion and 30 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: looking for participants now, as of the sponsor's last update on 21 Aug 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?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sébastien WEIBEL, MD (33388115157, sebastien.weibel@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of methylphenidate on the task vs. rest activation differential (treatment x group interaction) in a region defined by its involvement in the cognitive task and its responsiveness to methylphenidate. (time frame: 2 hours after intake of methylphenidate or placebo). 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 21 Aug 2026.