A research on the effects of HX-106 on symptom improvement and brain function change in child and adolescent patients with Attention Deficit Hyperactivity Disorder

Not Applicable

Completed

Conditions: Mental and behavioral disorders

Registration Number: KCT0005285

Lead Sponsor: Chung-Ang University

Brief Summary: The HX106 group showed a greater improvement in total attention (16.8% better) and inattention (17.2% better) scores, compared to the placebo group. The HX 106 group showed increased brain activity within the left precuneus, compared to the placebo group. The HX 106 group also showed increased functional connectivity from the precuneus seed to the left middle temporal gyrus, compared to the placebo group. In all participants, the changes in K-ARS scores were negatively correlated with changes in brain activity within the left middle temporal gyrus. Conclusions: HX 106 enhanced the effect of methylphenidate on ADHD symptom improvement, as well as increased brain activity within the attention regulation network. Therefore, HX 106 may provide a promising option for adjunctive therapy for patients with ADHD.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 38

Inclusion Criteria

(1) Pediatric patients between 6 and 23 years old
(2) Patients that weigh over 25 kg
(3) Patients diagnosed with ADHD as per DSM-IV diagnostic criteria or patients diagnosed with ADHD along with coexisting diseases
(4) Patients taking Methylphenidate or Atomoxetine
(5) IQ 70 or higher
(6) Patients who have been thoroughly informed of the details of the study by the researcher/person delegated by the research director and have consented for study participation by the patient and the patient’s guardian.

Exclusion Criteria

(1) Patients that did not agree to participate in the study
(2) IQ less than 70
(3) Patients with congenital genetic disease, cerebral palsy, or those with a clear history of acquired brain damage
(4) Patients diagnosed with a seizure disorder or other neurological disease

Study & Design

Study Type: Interventional Study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Resting-State Functional Magnetic Resonance Imaging (rs-fMRI);ADHD Rating Scale (ARS);Beck Depression Inventory (BDI);Barratt Impulsiveness Scale (BIS);Comprehensive Attention Test (CAT);Computerized NeuroCognitive Function test (CNT)

Secondary Outcome Measures