NIPH Clinical Trials Search

Elucidation of the mechanism of action of guanfacine in the brains of children with ADHD.

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	attention-deficit/hyperactivity disorder
Date of first enrollment	30/01/2026
Target sample size	184
Countries of recruitment
Study type	Interventional
Intervention(s)	Group A: At the first visit, subjects will take 1 mg of Intuniv. At the second visit, subjects will take a placebo and undergo tests (MRI, CANTAB cognitive function assessment, Gazefinder eye tracking, Conners3, etc.) five hours later. Group B: Subjects will take a placebo at the first visit and 1 mg of Intuniv at the second visit. Tests (MRI, CANTAB cognitive function assessment, Gazefinder eye tracking, Conners 3, etc.) will be performed five hours later.

Outcome(s)

Primary Outcome

Evaluating changes in resting-state functional connectivity (rsFC) between the guanfacine treatment group and the placebo group.

Secondary Outcome

1. Cognitive Function (CANTAB): Stop Signal Task (SST) and Spatial Working Memory (SWM) 2. Gaze Measurement (Gazefinder): Visual attention and gaze patterns are measured using Gazefinder. 3. Behavioral Assessment (Conners-3): To obtain parents' observations about the behaviors of participants. 4. Global Impressions (CGI, CGS & PG-I, PGI-S): To assess a patient's overall condition and changes in condition.

Key inclusion & exclusion criteria

Age minimum	>= 6age old
Age maximum	< 18age old
Gender	Both
Include criteria	[Children with ADHD] 1) Meet the diagnostic criteria for ADHD as defined in the 5th edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5), published by the American Psychiatric Association. 2) Written consent must be obtained through the free will of both the legal representative and the patient themselves, if aged 16 years or older. For individuals under 16 years of age, written consent must be obtained through the free will of the legal representative, and informed consent must be obtained from the patient themselves after receiving sufficient explanation and achieving a full understanding. 3) The age at which consent is given must be between 6 and 17 years. 4) Gender: Not restricted [Typically developing children] 1) Recruited healthy children with no history of psychiatric disorders. 2) Age: Children aged six years or older, but under 18 years of age at the time consent was obtained. 3) Gender: Not restricted 4) Individuals who, having received a sufficient explanation of the study and having achieved a full understanding of it, provided written consent of their own free will. If the subject is a minor or lacks the capacity to give consent, written consent was obtained from a legal representative.
Exclude criteria	[Children with ADHD] 1) Individuals with a history of hypersensitivity to any Guanfacine component. 2) Individuals with severe hepatic or renal impairment. 3) Individuals with physical conditions requiring strict dietary management, and Individuals with other serious physical conditions. 4) Pregnant individuals or those who may be pregnant. 5) Individuals with a history of cardiovascular or cerebrovascular diseases, such as Long QT syndrome (LQTS), arrhythmia, angina pectoris, myocardial infarction, or cerebral infarction. 6) Individuals with cardiac implantable electronic devices or neural pacemakers or other implanted metallic devices, such as arterial clips, and Individuals wearing orthodontic appliances 7) The principal investigator or co-investigator predicted that individuals with excessive head or body movement during MRI imaging, as well as those with severe claustrophobia or nyctophobia, be excluded. 8) Individuals deemed unsuitable as research subjects by the principal investigator or co-investigator. [Typically Developing Children] 1) Individuals deemed unsuitable as research subjects by the principal investigator or co-investigator. 2) For head MRI only, individuals meeting any of the following criteria are excluded: Individuals who are pregnant or may be pregnant Individuals with implanted cardiac or neural pacemakers, metallic implants such as arterial clips, or orthodontic appliances. Individuals with a fear of confined or dark spaces. Individuals with a history of conditions such as hernias who cannot maintain the same posture for extended periods.