Last updated: March 13, 2024
Sponsor: Johns Hopkins University
Overall Status: Trial Not Available
Phase
4
Condition
Attention Deficit/hyperactivity Disorder (Adhd - Adults)
Treatment
Placebo
Methylphenidate
Clinical Study ID
NCT06077669
IRB00408678
Ages 6-18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Age 6 to 18 years
- Diagnosis of ADHD
- A score of at least 3 (mildly ill) on the clinician administered Clinical GlobalImpressions-Severity (CGI-S)
Exclusion
Exclusion Criteria:
- Currently taking stimulant medications (within one week of first study visit).Patients will not be asked to discontinue any treatments for the purpose of thisresearch study. Subjects will include treatment naïve patients and patients who werepreviously treated with stimulant medications, but are not currently treated, and meetstudy criteria.
- Having an adverse reaction to methylphenidate, or other stimulant medication
- Current psychiatric disorder, including bipolar I or II disorder, major depressive,disorder, obsessive-compulsive disorder, autism spectrum disorder, Tourette syndrome,or history of psychosis
- Patient is at risk for clinically significant deterioration due to study protocol, asassessed by primary medical investigator (Dr. Grant)
- Confirmed genetic disorder with cognitive and/or behavioral disturbances
- Active, unstable medical illness that may interfere with cognition or compromisessafety of the patient
- History of head trauma with loss of consciousness or any evidence of functionalimpairment due to, and persisting after, head trauma
- Neurological disorder, mental retardation, intellectual or disability, or othernon-ADHD cause of cognitive impairment
- Pregnant or breast-feeding women
- Having a contraindication to MRI, including a pacemaker, defibrillator or othermedical implant, other metal objects, or claustrophobia, or for having braces or othermetal in the head region (likely to create an artifact on the MRI scans).
- Currently smoking or using controlled or illicit substances, including alcohol.
Study Design
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 4
Study Start date:
April 16, 2024
Estimated Completion Date:
January 31, 2029
Connect with a study center
Johns Hopkins School of Medicine
Baltimore, Maryland 21287
United StatesSite Not Available
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