NCT04781972 Multimodal Brain Imaging of the Neural Effects of Methylphenidate in Patients With ADHD
| NCT ID | NCT04781972 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Johns Hopkins University |
| Condition | ADHD - Combined Type |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2021-07-27 |
| Primary Completion | 2028-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 30 participants in total. It began in 2021-07-27 with a primary completion date of 2028-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The investigators' goal is to develop neuroimaging biomarkers to predict response to treatment with methylphenidate, which then can be used in the development of novel pharmacological treatments for attention-deficit/hyperactivity disorder (ADHD). The overall objective of this study is to measure the changes in task-related neural activity related to symptoms of ADHD (measured by functional MRI) and brain glutamate levels (measured by magnetic resonance spectroscopy, MRS) after treatment with methylphenidate (MPH). This will be a double-blind crossover of methylphenidate and placebo in adults with ADHD. Participants will complete neuropsychological testing along with fMRI and MRS scans after a single dose of each treatment.
Eligibility Criteria
Inclusion Criteria: * right handed Exclusion Criteria: * pregnant or breast feeding * past or current neurological disorder * non-ADHD cause of cognitive impairment * uncontrolled medical disorder * head trauma with loss of consciousness in the last year or any evidence of functional impairment due to and persisting after head trauma * having an adverse reaction to methylphenidate, or other stimulant medication * having a contraindication to MRI * current smoking
Contact & Investigator
Kristin L Bigos, PhD
PRINCIPAL INVESTIGATOR
Johns Hopkins School of Medicine
Frequently Asked Questions
Who can join the NCT04781972 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, up to 40 Years, studying ADHD - Combined Type. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04781972 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT04781972 currently recruiting?
Yes, NCT04781972 is actively recruiting participants. Contact the research team at kbigos1@jhu.edu for enrollment information.
Where is the NCT04781972 trial being conducted?
This trial is being conducted at Baltimore, United States.
Who is sponsoring the NCT04781972 clinical trial?
NCT04781972 is sponsored by Johns Hopkins University. The principal investigator is Kristin L Bigos, PhD at Johns Hopkins School of Medicine. The trial plans to enroll 30 participants.