Phase 4 ADHD Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• Children who are between 4 years 0 months and 5 years 9 months old at the first visit, and are considered generally healthy
• A parent or legal guardian must be willing and able to sign a consent form before any study activities begin
• Children who have been formally diagnosed with ADHD using standard diagnostic tools (DSM-IV-TR criteria confirmed with a structured interview called the K-SADS-PL)
• Children whose ADHD symptom scores on a standard rating scale meet or exceed a set threshold (28 or higher for boys, 24 or higher for girls) at both the screening and baseline visits
• Children whose ADHD is rated as "moderate or worse" on a standard severity scale at both the screening and baseline visits
• Children who have either tried a non-medication approach to managing ADHD without enough improvement, or whose symptoms are severe enough that the treating doctor considers medication appropriate without first trying non-medication approaches
• Children who take part in a structured group activity outside the home (such as preschool, kindergarten, sports, childcare, or similar programs) at least 2 days per week during the study
• Children who have not started any new behavioural therapy within 30 days before the screening visit, and whose behavioural therapy plans are not expected to change during the study
• Children currently on ADHD medication whose symptoms are still not well controlled, provided they stop taking that medication at least 7 days before the baseline visit and meet all other criteria
• Children with no current health condition that, in the investigator's opinion, would interfere with study results or increase risk
• Children who have lived with the same parent(s) or guardian(s), or under a shared custody arrangement, for at least 6 months before the screening visit
• Children whose body weight is at or above the 5th percentile for their age and sex at both the screening and baseline visits

Who may not be able to join:

• Children whose primary diagnosis is a psychiatric condition other than ADHD, or who have a secondary psychiatric condition that the investigator believes would interfere with the study
• Children with a current major neurological disorder; those with a history of seizures, seizure-like events, a family history of seizure disorder, or febrile seizures will be assessed individually (confirm with trial site)
• Children who have a parent or sibling diagnosed with Bipolar Disorder
• Children with a history of global developmental delay or intellectual disability
• Children with a significant ongoing physical health condition, as determined by the investigator
• Children whose body mass index (BMI) is above the 95th percentile for their age and sex at the screening or baseline visit
• Children with blood pressure and pulse rate both above the 95th percentile for their age, sex, and height at the screening or baseline visit
• Children with a clinically significant heart rhythm finding on an ECG at the screening visit
• Children who have previously taken the study drug (SPN-812/viloxazine), stopped it due to lack of effect or side effects, or have had an allergic or intolerance reaction to it
• Children who are unable to swallow pudding or applesauce and also cannot swallow a capsule whole
• Children with a food allergy, intolerance, or dietary restriction that the investigator believes would interfere with participation
• Children who have taken part in another clinical drug study within 30 days (or 5 half-lives of that drug, whichever is longer) before the baseline visit
• Children who test positive for drugs in a urine test at the screening visit (a positive result for stimulants is allowed only if the child is currently prescribed a stimulant ADHD medication and stops taking it at least 7 days before the baseline visit)
• Children who are taking certain medications that interact with the study drug, including medications classified as CYP1A2 substrates (such as theophylline or melatonin) (confirm with trial site for a full list)
• Children who have had thoughts of suicide or suicidal behaviour in the 6 months before the screening visit, or who have ever made a suicide attempt
• Children who, for any other reason, the investigator believes should not participate

Important: Always verify eligibility with the trial site directly before applying.