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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

Status
Not yet recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-516902-46-00
Acronym
7347
Enrollment
80
Registered
2024-09-19
Start date
Unknown
Completion date
Unknown
Last updated
2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Attention Deficit Hyperactivity Disorder (ADHD)

Brief summary

Effect of methylphenidate on the task vs. rest in a region defined by its involvement in the cognitive task and its reactivity to methylphenidate. ROI (Region of Interest) analysis to maximize power.

Detailed description

Decrease in rCBF (regional Cerebral Blood Flow) in the methylphenidate condition vs. placebo, in the different groups., Improved cognitive performance on tests of sustained attention, working memory and flexibility following the administration of methylphenidate, in the different groups., Stabilization of the power of the EEG spectrum in the low frequencies (delta (1-4Hz) and theta (4-8Hz)) in the methylphenidate condition vs. placebo., MRI: Interaction group x treatment x task on cerebral activation linked to sustained attention and linked to the inhibition corresponding to each of these tasks., EEG: Group x treatment x task interaction on the amplitude of the XML File Identifier: 0Vmd7NrSRK8JeP+9ISLPaO9Oq+U= Page 14/26 P300 wave linked to sustained attention (P300b) and linked to inhibition (P300a) corresponding to each of these tasks.

Interventions

DRUGRITALINE 10 mg
DRUGcomprimé sécable
DRUGFORMULE 515 AP-HP (placebo)- préparation hospitalière

Sponsors

Les Hopitaux Universitaires De Strasbourg
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
Effect of methylphenidate on the task vs. rest in a region defined by its involvement in the cognitive task and its reactivity to methylphenidate. ROI (Region of Interest) analysis to maximize power.

Secondary

MeasureTime frame
Decrease in rCBF (regional Cerebral Blood Flow) in the methylphenidate condition vs. placebo, in the different groups., Improved cognitive performance on tests of sustained attention, working memory and flexibility following the administration of methylphenidate, in the different groups., Stabilization of the power of the EEG spectrum in the low frequencies (delta (1-4Hz) and theta (4-8Hz)) in the methylphenidate condition vs. placebo., MRI: Interaction group x treatment x task on cerebral activation linked to sustained attention and linked to the inhibition corresponding to each of these tasks., EEG: Group x treatment x task interaction on the amplitude of the XML File Identifier: 0Vmd7NrSRK8JeP+9ISLPaO9Oq+U= Page 14/26 P300 wave linked to sustained attention (P300b) and linked to inhibition (P300a) corresponding to each of these tasks.

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026