Phase 3 ADHD 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:

Criteria that apply to all participants:

• Adults between 18 and 60 years old (male or female)
• People who are covered by a health insurance scheme
• People who are able to understand the goals and risks of the study and can give written, dated consent
• People who have been informed of the results of their pre-study medical check-up
• Women who could become pregnant must have a negative blood pregnancy test and use an effective form of contraception throughout the study (such as an IUD, sterilisation, the pill, injection, implant, or vaginal ring), and must agree not to take a pregnancy test before each MRI session

Group A — People with ADHD and no mood disorder:

• People who have a confirmed ADHD diagnosis under DSM-5 criteria, including that symptoms were present before age 12 (though the diagnosis itself does not need to have been made at that age)
• People whether or not they are currently taking methylphenidate (a common ADHD medication)

Group B — People whose attention difficulties are linked to or worsened by a mood disorder:

• People who have a diagnosis of recurrent depression or bipolar disorder (under DSM-5 criteria), and also show at least 5 ADHD-type symptoms of inattention and/or hyperactivity/impulsivity
• People whose mood condition is currently stable (low scores on recognised depression and mania rating scales) and has been clinically stable for at least 6 weeks before joining, with no active treatment for an acute episode
• People whose ADHD-type symptoms did not significantly affect daily life during childhood or adolescence, but do significantly affect daily social, academic, or work functioning now
• People whether or not they are taking approved mood disorder treatments such as certain mood stabilisers, certain antidepressants at specified doses, or stable doses of benzodiazepines for more than one month
• People whether or not they are currently taking methylphenidate

Group C — Healthy volunteers (control group):

• People with no history of any psychiatric or neurological condition

Who may not be able to join:

Applies to all groups:

• People who have a medical reason why they cannot take methylphenidate, including: allergy to the medication, glaucoma, a tumour of the adrenal gland (pheochromocytoma), overactive thyroid, or use of certain other medications (including certain nasal or oral decongestants, or irreversible MAOIs)
• People with pre-existing heart or blood vessel conditions, including severe high blood pressure, heart failure, angina, certain heart rhythm problems, a history of heart attack, or certain inherited heart conditions
• People with pre-existing brain or blood vessel conditions in the brain, including aneurysms, vasculitis, or prior stroke
• People with a wheat allergy (other than coeliac disease)
• People with a current diagnosis or history of severe depression, anorexia, suicidal tendencies, psychotic symptoms, severe mood disorders, mania, schizophrenia, or certain personality disorders
• People with a diagnosis or history of poorly controlled severe (Type 1) bipolar disorder
• People who cannot have an MRI scan, for example due to having a non-removable metal implant, pacemaker, certain prostheses, implanted medication pump, vascular clip or stent, certain heart valves, or a ventricular shunt
• People with a medical history that may have affected brain structure, such as complications at birth, brain surgery, epilepsy, stroke, or a head injury involving more than 15 minutes of unconsciousness
• People who have had general anaesthesia or electroconvulsive therapy (ECT) within the 3 months before joining
• People with a substance use disorder as defined by DSM-5 criteria (tobacco is excluded from this)
• Women who are pregnant or breastfeeding
• Women of childbearing age who are not using effective contraception
• People with a severe or unstable physical health condition
• People who are currently detained or receiving involuntary psychiatric care
• People under a justice protection order
• People who are under a legal guardianship or protection arrangement
• People in a situation where giving informed consent is not possible (for example, due to an emergency situation or significant difficulty understanding)
• People who are currently within an exclusion period from another clinical trial

Group A only (ADHD without mood disorder):

• People who currently have a mood disorder
• People who have a first-degree relative (parent, sibling, or child) with a history of bipolar disorder
• People currently taking certain non-approved psychiatric medications, including any antidepressants, antipsychotics, sedating antihistamines, regular sleeping tablets, or unstable doses of benzodiazepines

Group B only (ADHD linked to mood disorder):

• People whose mood disorder is currently in an active/acute phase, based on scores on recognised depression and mania rating scales
• People taking certain non-approved psychiatric medications, including antipsychotics, sedating antihistamines, tricyclic antidepressants, MAOIs, certain antidepressants above specified dose limits, or unstable doses of benzodiazepines

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