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Methylphenidate immediate release

Phase 3

Adult ADHD | Small molecule | Psychiatry |Pulmonx Corporation|Last Updated: Aug 21, 2026

Target and mechanism

Molecular targetSLC6A3, SLC6A2
Target classInhibitor
ModalitySmall molecule
ChEMBLCHEMBL796

Also known as Methylphenidate immediate release 25mg

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLEDBiomarker
Total Trials1
Total Enrollment80

FDA Designations

No designations recorded

Clinical trial landscape

Methylphenidate immediate release · 1 trial · 2 indications

Phase 3 1
NCT05832489EEG-MRI Imaging of Methylphenidate Effects in Adult ADHD and Attentional Symptoms in Mood DisordersAdult ADHD
RECRUITING80 Analytics
PHASE3RECRUITING
EEG-MRI Imaging of Methylphenidate Effects in Adult ADHD and Attentional Symptoms in Mood Disorders
Adult ADHDUnlock trial analytics

Study Endpoints

Primary Endpoints

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.
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.

Secondary Endpoints

Decrease in rCBF (regional Cerebral Blood Flow) in the methylphenidate vs. placebo condition, in the different groups (group x treatment interaction).
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.
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
3 hours after intake of methylphenidate or placebo
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Group AEXPERIMENTALAdult patients with ADHD (ADHD-P) receive a placebo or 25 mg of methylphenidate 45min before the first and second imaging sessions (MRI+EEG)
Group BEXPERIMENTALAdult 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 CEXPERIMENTALAdult Healthy controls receive a placebo or 25 mg of methylphenidate 45min before the first and second imaging sessions (MRI+EEG)

Interventions

NameTypeDescription
PlaceboDRUGPatients 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 25mgDRUGPatients 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.
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Eligibility Criteria

Age Range18 Years to 60 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion criteria 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 ha...

Countries:France
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