Phase 2 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:

• People who have been diagnosed with ADHD (according to recognised medical guidelines) where symptoms began before the age of 12
• People whose ADHD symptoms score at least 32 on a specific ADHD checklist used at the first study visit
• People who have moderate to severe depression (diagnosed under recognised medical classifications) with a depression rating score above 20 at the first study visit
• People whose overall illness severity is rated at 4 or higher on a standard scale at the first study visit
• People who are currently taking certain antidepressants — specifically SSRIs or SNRIs — at stable doses within the two weeks before joining, within specific dose ranges (confirm with trial site for exact doses)
• People aged 18 to 65 at the time of enrolment
• People whose heart rhythm measurement (QTc interval) falls within normal limits — up to 470 ms for males and 480 ms for females
• People who are either not currently taking ADHD medication, or who are willing and able to stop their ADHD medication for the duration of the study after discussion with their treating doctor
• People who are willing and able to stop certain other medications listed as exclusions, if applicable, after discussion with their treating doctor
• People who have provided written consent before any study procedures begin
• People who are willing and able to follow all study procedures and the study plan

Who may not be able to join:

• People who currently have, or have a history of, psychotic symptoms, schizophrenia, bipolar disorder, or manic episodes
• People who have had a substance abuse disorder within the last 6 months before joining the trial
• People whose body mass index (BMI — a measure of weight relative to height) is below 18.5 or above 35
• People who have previously experienced serotonin syndrome (a serious reaction involving too much serotonin in the body)
• People who have a history of seizures or who take anti-seizure medication
• People who have another uncontrolled psychiatric condition that requires medication or may interfere with taking part in the trial
• People with known heart or cardiovascular conditions, including structural heart problems, significantly high blood pressure (systolic 160 mmHg or higher, or diastolic 100 mmHg or higher), heart failure, previous heart attack, artery disease, angina, certain inherited heart conditions, heart muscle disease, or serious heart rhythm disorders
• People with significant liver, gut, kidney, blood, or cancer-related conditions, as determined by the study doctor
• People diagnosed with glaucoma (a condition affecting eye pressure), an overactive thyroid, a type of adrenal gland tumour (pheochromocytoma), or a rare blood disorder called porphyria
• People who have been diagnosed with, or have a family history of, Tourette's syndrome or dystonia (a movement disorder)
• People with existing brain or blood vessel conditions such as a brain aneurysm, abnormal blood vessels, vasculitis (blood vessel inflammation), or a history of stroke
• People with immune system disorders, such as those who have had an organ transplant or are living with HIV
• People with a known allergy or sensitivity to any ingredient in the trial medication, including those with a rare inherited condition called fructose intolerance
• People of reproductive potential who are not willing to use highly effective contraception (such as the contraceptive pill or an intrauterine device) throughout the study period
• People who are pregnant or breastfeeding
• People who are currently participating in, or have participated in, another interventional clinical trial within the 30 days before this trial starts
• People who are in institutional care under a court or regulatory order
• People who are staff members of the trial centre, the study sponsor, or the research organisation involved, or who are close relatives of the investigator
• People who are not able to understand the nature and impact of the trial due to legal incapacity or other circumstances
• People who are currently taking, or have taken within the last 2 weeks, any of the following medications (due to possible interactions): most antipsychotics (quetiapine up to 100 mg/day may be an exception — confirm with trial site), SSRIs or SNRIs above certain dose limits, MAO inhibitors, tricyclic antidepressants, benzodiazepines or Z-drugs (sleep medications), most atypical antidepressants (trazodone at certain doses may be an exception — confirm with trial site), bupropion, certain heart rhythm medications, certain antibiotics (including macrolides, fluoroquinolones, and linezolid), opioids, hydroxychloroquine or chloroquine, ketoconazole, aspirin above 300 mg/day, diphenhydramine, apixaban, metoprolol, pregabalin, budesonide/formoterol, or albuterol/salbutamol

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