Phase 4 Autism Spectrum Disorder Trial, Recruiting

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

Who might be able to join this trial:

For children with both Autism Spectrum Disorder (ASD) and ADHD:

• Children and teenagers aged 8 to 18 years (boys or girls)
• Those who are able to communicate verbally, as determined by a clinician
• Those who have been formally diagnosed with both ADHD and ASD through a clinical interview, meeting current diagnostic standards
• Those whose ADHD symptoms are at least moderately severe, based on standardised rating scales completed by a clinician
• Those whose ASD symptoms are at least moderately severe, based on standardised rating scales
• Those who also have disruptive behaviour, mood, or anxiety conditions may still be considered, as long as they do not meet any of the exclusion criteria
• Those who are currently on a stable medication routine for mental health or behavioural conditions
• Those who are able to understand the study, make decisions for themselves, and are willing to sign a consent form approved by an ethics board
• Those who are able to communicate with the research team and cooperate with all required tests and procedures
• Those whose body weight falls between the 5th and 95th percentile for their age, according to CDC child BMI categories

For typically developing children (control participants, without ASD or ADHD):

• Children matched in age, sex, and IQ to the ASD participants in the study
• Those who do not show significant signs of ASD, based on a screening questionnaire
• Those who do not show significant ADHD symptoms, based on a parent-completed rating scale
• Those who do not show significant signs of other psychological or behavioural difficulties, based on a standardised checklist
• Those whose body weight falls between the 5th and 95th percentile for their age, according to CDC child BMI categories

Who may not be able to join:

• Those with intellectual disability or significantly impaired intellectual functioning (applies to ASD participants; assessed through language ability, intellectual performance, and capacity for self-care)
• Those who are unable to communicate verbally or have severely impaired spoken language skills
• Those who do not have a strong enough command of English, or who would need an interpreter
• Those who are unable to swallow tablets or capsules (ASD participants only)
• Girls or women who are pregnant, breastfeeding, or who test positive on a pregnancy test
• Those with an untreated thyroid condition (either overactive or underactive)
• Those who have had seizures not caused by fever in the past month, without a clear and fully resolved explanation
• Those with a diagnosis of glaucoma (ASD participants only)
• Those with a history of kidney or liver problems
• Those with a serious ongoing physical illness
• Those with a personal history of heart disease, or a family history of heart disease or death from heart causes that occurred at a younger age (ASD participants only)
• Those with known, untreated risk factors for heart problems — such as high blood pressure, irregular heartbeat, or a family history of sudden death — along with active symptoms that the investigator considers a safety concern (ASD participants only)
• Those with an unstable physical health condition that requires ongoing medical attention
• Those whose psychiatric condition is considered clinically unstable, or who have been assessed as a serious risk of harm to themselves or others in the past 30 days
• Those currently experiencing severe symptoms of a major psychiatric disorder, as assessed by a clinician (within the past 30 days)
• Those currently experiencing active symptoms of anorexia or bulimia
• Those who have used substances (other than nicotine, recreational cannabis, or caffeine) in the past 3 months
• Those who have started a new psychological therapy or behavioural intervention within 4 weeks before being enrolled into the study
• Those whose current mental health or behavioural medication dose has not been stable for at least 4 weeks before the study start
• Those who have been treated with a type of medication called an MAOI within the 2 weeks before starting the study medication
• Those currently taking stimulant medications (note: ASD participants on stable non-stimulant ADHD medications may still be considered)
• Those with a history of ADHD symptoms not responding to amphetamine-based medication when taken at a therapeutic dose for at least one week (ASD participants only)
• Those who have previously had a poor response to, or poor tolerance of, mixed amphetamine salt medications (ASD participants only)
• Those with a known allergy to amphetamine or dextroamphetamine (ASD participants only)
• Immediate family members of the investigators running the trial (such as a spouse, parent, child, grandparent, or grandchild)
• Those for whom MRI scanning is not safe or suitable, based on a standard MRI screening checklist (control participants who cannot have an MRI will not be eligible; confirm with trial site for ASD participants)

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