Attention-Deficit/Hyperactivity Disorder
Conditions
Interventions
Test Product Group:CreNeuroSTM MOOD FISH OIL (FOR AGES 6-18) Softgels
Sponsors
The first affiliated hospital of anhui medical university
Eligibility
Sex/Gender
All
Age
6 Years to 18 Years
Inclusion criteria
Inclusion criteria: 1. Aged 6–18 years, regardless of gender; 2. Meets the diagnostic criteria for ADHD as outlined in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5); 3. Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHD-RS): Total score for males >= 25 points and total score for females >= 22 points; 4. CGI-S score of 3 or higher; 5. Raven's Intelligence Test standard score >= 5%, or Raven's Intelligence Test IQ >= 70; 6. Participation is voluntary; the parent or legal guardian of each trial participant must sign an informed consent form; 7. Female patients who are neither pregnant nor breastfeeding; if a female patient has already experienced menarche, she must undergo a urine pregnancy test, and the result must be negative.
Exclusion criteria
Exclusion criteria: 1.Previous treatment with ADHD medications (such as central nervous system stimulants, non-central nervous system stimulants, traditional Chinese medicine, etc.) has been ineffective; 2.Suffering from diseases of vital organs such as the heart, liver, lungs, or kidneys, as well as blood disorders or neoplastic diseases; 3.Hearing impairment resulting in symptoms similar to those of attention-deficit/hyperactivity disorder (ADHD) in children; 4.Patients who have consumed fish =3 times per week in the past, have taken other nutritional supplements related to attention, memory, learning disabilities, mood, or sleep within the past month, or have taken or are currently taking fish oil, n-3 PUFA supplements, folic acid, or L-5-methyltetrahydrofolate within the past 6 months; 5.Individuals with allergies to fish oil, folic acid/L-5-methyltetrahydrofolic acid, or any component of the study product (including excipients and sweeteners); 6.Patients with comorbid psychiatric disorders, pervasive developmental disorders, intellectual disability, or a history of suicide or self-harm (including those with severe anxiety or depression); a history of definite traumatic brain injury or severe systemic disease; or neurological disorders such as epilepsy or tic disorders; 7.Patients with abnormal liver or kidney function: ALT or AST = 2 times the upper limit of normal. Participants with clinically significant thyroid dysfunction (where one or more of TSH, FT3, or FT4 exceeds the normal range and the investigator deems it clinically significant); participants who have been receiving a stable dose of thyroid medication for more than 3 months and whose thyroid function is within the normal range are permitted. 8.Participants planning to change ongoing non-pharmacological treatments (such as psychoeducation, psychotherapy, special education, and functional training) during the study; Participants not currently receiving non-pharmacological treatment but planning to initiate new non-pharmacological treatment during the study; 9.Use of the following medications within 14 days prior to enrollment: Western medications, Chinese herbal medicines, and proprietary Chinese medicines for the treatment of ADHD, such as amphetamine-like drugs, methylphenidate, atomoxetine, clonidine, guanfacine, Jingling Oral Solution, and Dimo Ning Shen Oral Solution; Medications that affect the central nervous system, cognitive function, or mental state: such as norepinephrine reuptake inhibitors, anxiolytics, sedatives/hypnotics, antidepressants, monoamine oxidase inhibitors (MAOIs), central nervous system stimulants, first-generation antihistamines, etc.; 10.Participants who have participated in or are currently participating in other non-interventional studies, or any clinical trials involving investigational drugs, marketed drugs, or medical devices within the past three months; 11.Participants whose guardians are unable to cooperate with medication logging, follow-up, or testing (e.g., due to long-term business travel or communication difficulties); 12.Participants who are unable to cooperate with psychological assessments due to comprehension difficulties, poor cooperation, or other reasons; 13.Other circumstances where the investigator determines there is a high risk of dropout or the subject is unsuitable for participation in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Children’s Sleep Habits Questionnaire (CSHQ) (ages 6–12) / Sleep Disturbance Scale for Children (SDSC) (ages 13–18);Go/No-Go Task Test;Attention-Deficit/Hyperactivity Disorder Screening Scale (SNAP-IV);Conners Brief Symptom Questionnaire;Learning Disabilities Screening Scale (PRS);Screening for Childhood Anxiety and Depressive Disorders (SCARED);Clinical Global Impression Scale (CGI);Efficacy: SNAP-IV reduction = 30%, and CGI-I = 2 points;Subgroup Analysis of ADHD Subtypes (Attention-Deficit/Hyperactivity Disorder);Numerical Range Test;Children’s Depression Inventory (CDI); | — |
Secondary
| Measure | Time frame |
|---|---|
| VR-CPT Test;Vital Signs;TSH? FT3?FT4;Pregnancy in Urine (in women who have already had their first menstrual period);Homocysteine;Liver and Kidney Function;Complete Blood Count;Adverse Events; | — |
Countries
China
Contacts
Public ContactLi Yang
The first affiliated hospital of anhui medical university
Outcome results
None listed