Optical Topography based effect of Guanfacine Hydrochloride in ADHD Children

JRCT ID: jRCTs031190060

Registered date:24/07/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Attention Deficit Hyperactivity Disorder(ADHD)
• Date of first enrollment: 27/12/2019
• Target sample size: 40
• Study type: Interventional

Intervention(s)

arm A: Guanfacine 1mg on primary, placebo on second period.
arm B: placebo on primary, Guanfacine 1mg on second period.

Outcome(s)

• Primary Outcome: OxyHb concentration signal change in the brain region of interest (right prefrontal cortex: between the medial and inferior frontal gyri) (i.e., right hemisphere Channel 10 [CH10])

Secondary Outcome

Action endpoint: Go/No-go task parameters ((i) Go task reaction time (reaction time), (ii) No-go task correct response rate (commission error),(iii)Go task correct response rate(omission error))
Exploratory endpoint: OxyHb concentration changes in other brain regions than the region of interest (right prefrontal cortex: between the medial and inferior frontal gyri)

Key inclusion & exclusion criteria

• Age minimum: >= 6age old
• Age maximum: < 12age old
• Gender: Both

Include criteria

1.Male or female right-handed outpatient aged 6 to <12 years at the time of consent
2.Written voluntary consent to participate in the study can be obtained from the patient's legally acceptable representative. If possible, written informed assent from the patient should also be obtained.
3.Patients coded to any of the following subtypes of AD/HD according to the diagnostic criteria in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5):
-314.01 Combined Type
-314.00 Predominantly Inattentive Type
-314.01 Predominantly Hyperactive-Impulsive Type
4.Patients who were previously assessed using the Wechsler Intelligence Scale for Children, Fourth Edition (WISC-IV) and had a Full Scale IQ score of 70
5.Patients on oral GXR 1 mg/day for at least 8 weeks at the time of consent and confirmed the effectiveness of GXR by the investigator.
6.Patients with a body weight of 17 to < 38 kg at the time of consent

Exclude criteria

1.Patients with a history of hypersensitivity to guanfacine hydrochloride
2.Female patients who are pregnant or possibly pregnant, or who desire to become pregnant during the study period
3.Patients with atrioventricular block (second or third degree)
4.Patients with current or past history of hypotension, orthostatic hypotension, bradycardia Note 1), cardiovascular disease, or patients receiving any drug to reduce blood pressure or pulse rate with the exception of drugs to treat AD/HD
5.Patients with current or past history of hypertension Note 2)
6.Patients with current or past history of arrhythmia, congenital long QT syndrome, or patients receiving any drug known to prolong QT
7.Patients with current or past history of ischemic heart disease such as angina pectoris or myocardial infarction
8.Patients with cerebrovascular disorder such as cerebral infarction
9.Patients with concurrent diseases such as severe liver disorder, renal disorder, cardiac disease, pulmonary disease, hematological disease, or metabolic disease
10.Patients in a depressed state
11.Patients with psychiatric disease such as schizophrenia spectrum disorder or bipolar disorder
12.Patients with autism spectrum disorder
13.Patients with personality disorder or intellectual disability
14.Patients with conduct disorder, with the exception of oppositional defiant disorder
15.Patients with abnormal electrocardiogram or laboratory data requiring additional testing or medical intervention, with the exclusion of conditions judged to be transient or allergic disorder by the investigator
16.Patients with current or past history of suicide attempt or suicidal ideation
17.Patients with severe underweight or severe obesity Note 3)
18.Patients with substance abuse or substance dependence Note 4)
19.Patients who used any investigational drug or unapproved drug within 30 days before the start of screening (informed consent)
20. Other patients who are unsuitable for participation in this study in the opinion of the investigator (e.g.,
patients who would not complete the study, patients who could suffer disadvantages from participation in the study, or patients who would not allow safety assurance during the study)

Related Information

• Primary Sponsor: Monden Yukifumi
• Secondary Sponsor: SHIONOGI & CO.,LTD
• Source(s) of Monetary Support: Shire International GmbH