Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:26 AM
Ignite Modification Date:
2025-12-25 @ 12:26 AM
NCT ID:
NCT01098058
Eligibility Criteria:
Inclusion Criteria:
* A diagnosis of adult ADHD according to NICE guidelines i.e. if there was evidence from both the participant and the informant (where available) that 1) the participant met DSM-IV criteria for Adult ADHD both in childhood and adulthood 2) that they experienced at least moderate psychological, social and/or educational or occupational impairment in multiple settings and 3) symptoms occurred in two or more settings including social, familial, educational and/or occupational settings. Participants will have received a diagnosis either from the Adult ADHD Service, Maudsley Hospital, London, UK or another specialist/secondary care service (in this case a copy of the diagnostic report will be required). Participants will either already be attending follow-up clinics, including psychoeducation workshops, or will have been recently referred to the service for medication follow-up or psychological treatment.
* Currently score 6 or more on the inattentive or hyperactive/impulsive subscale of the Adult Barkley Current Behaviour Scale
* Clinical severity of at least a moderate level (Clinical Global Impression score of 4 or above)
* Able to attend the clinic regularly and reliably
Exclusion Criteria:
* Clinically significant anxiety disorder
* Current episode major depression, current suicidality or self-harm (score of moderate or high suicidality on the M.I.N.I.)
* Acquired brain injury
* Primary diagnosis of psychosis or bipolar disorder
* Pervasive developmental disorder(score of \<= 32 on Autism Spectrum Quotient - although if the assessor judges that items that confound with ADHD have caused the score to be elevated, people with scores \>=32 can still enter the trial)
* Diagnosis of personality disorder
* Active substance misuse/dependence in last three months
* Verbal IQ \<80
* Not able to comply with the requirements of a randomised controlled trial
* If the assessor does not perceive ADHD to be the primary problem
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01098058
Study Brief:
Protocol Section:
NCT01098058