Actively Recruiting
EEG-MRI Imaging of Methylphenidate Effects in Adult ADHD and Attentional Symptoms in Mood Disorders
Led by University Hospital, Strasbourg, France · Updated on 2024-07-31
80
Participants Needed
1
Research Sites
165 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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: 1. To determine the effect of methylphenidate on baseline brain flow in the two clinical populations and in controls (healthy subjects). 2. To determine whether methylphenidate has a different impact on cognitive performance in the two clinical populations studied and in comparison to controls (healthy subjects). 3. To confirm the effect of methylphenidate on the maintenance of cortical arousal. 4. To distinguish the brain networks impacted by methylphenidate (maintenance of attention or inhibition) with MRI and EEG.
CONDITIONS
Official Title
EEG-MRI Imaging of Methylphenidate Effects in Adult ADHD and Attentional Symptoms in Mood Disorders
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 60 years
- Affiliated with a social protection health insurance scheme
- Able to understand the study and provide signed informed consent
- Informed of prior medical examination results
- For women of childbearing age: negative pregnancy test and effective contraception during the study
- For Group A: diagnosed ADHD with symptoms before age 12, with or without methylphenidate treatment
- For Group B: ADHD symptoms linked to mood disorders (recurrent depressive or bipolar disorder), clinically stable and euthymic for at least 6 weeks, meeting adult ADHD criteria, with or without mood disorder treatment and methylphenidate treatment
- For Group C: healthy subjects with no psychiatric or neurological history
You will not qualify if you...
- Allergy or contraindications to methylphenidate including hypersensitivity, glaucoma, pheochromocytoma, certain medications, hyperthyroidism, severe cardiovascular or cerebrovascular diseases, wheat allergy
- Severe depression, anorexia, suicidal tendencies, psychosis, severe mood disorders, mania, schizophrenia, psychopathic or borderline personality disorders
- Severe or uncontrolled bipolar disorder
- Contraindications to MRI such as implanted devices or metal
- History of brain injury or conditions affecting brain anatomy or function
- Recent general anesthesia or electroconvulsive therapy
- Substance use disorder (except tobacco)
- Pregnancy or breastfeeding without effective contraception
- Severe or unstable medical conditions
- Legal or protective custody status preventing consent
- Participation in another clinical trial exclusion period
- For Group A: current mood disorder, family history of bipolar disorder, unauthorized psychotropic drug use
- For Group B: acute mood disorder phase, unauthorized psychotropic drug use including certain antidepressants and unstable benzodiazepine doses
AI-Screening
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Trial Site Locations
Total: 1 location
1
Service de Psychiatrie 2, Hôpitaux Universitaires de Strasbourg
Strasbourg, France, 67091
Actively Recruiting
Research Team
S
Sébastien WEIBEL, MD
CONTACT
H
Hélène SOAVELO
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
BASIC_SCIENCE
Number of Arms
3
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