Landscape Study
Research type
Research Study
Full title
Prevalence of ADHD and health outcomes in adult outpatients with psychiatric disorders: a multi-country, two-part, observational study.
IRAS ID
329132
Contact name
Rajesh Nair
Contact email
Sponsor organisation
Takeda Pharmaceuticals International AG,
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
NCT04943796, Registration number from ClinicalTrials.gov
Duration of Study in the UK
1 years, 2 months, 1 days
Research summary
The purpose of this two-part study is to provide awareness of the underdiagnosis of adult attention-deficit/hyperactivity disorder (ADHD) and produce evidence to support improved under diagnosis prevention among clinicians, researchers, and policy makers.
Part I aims to estimate the prevalence of ADHD diagnosis in adult outpatients with at least 12 months duration of psychiatric conditions who therefore are assessed consecutively for ADHD (as per routine clinical practice).
Part II aims to describe the quality of life of adult patients with ADHD and comorbid mental disorders identified in Part I, as well as their ability to function autonomously in work, interpersonal relationships, and everyday activities.
This study will include the collection of pseudonymised data (i.e., anonymous to non-site staff) by physicians during face-to-face interviews or self-reported by study participants during routine clinical visits or remote interviews. The study will also include the collection of historical data from medical charts or electronic health records that will also be pseudonymised to maintain patient confidentiality.
Approximately 100 patients will be recruited in Part I and 17 patients in Part II across 2-4 sites in the UK and followed-up for 9 months after ADHD diagnosis within the Part II. Patients included in Part I will be over 18 years old and have a previous diagnosis of at least one psychiatric disorder of at least 12 months duration and they will have been consecutively assessed for ADHD, as per routine clinical practice. Those patients from Part I who are positively diagnosed for ADHD will be included in Part II. Only patients able to consent, read and write will be included.
Lay summary of study results: This study looked at how common attention deficit hyperactivity disorder (ADHD) is in adults who are already receiving outpatient care for other mental health conditions, and how ADHD affects daily functioning and quality of life. ADHD is a condition that can affect attention, activity levels and impulse control, and it is often missed in adults because symptoms can overlap with other mental health problems. Adults attending routine psychiatric appointments in six countries, including the United Kingdom, were assessed for ADHD using standard clinical methods. Almost three out of four people assessed were newly diagnosed with ADHD, showing that ADHD is frequently under‑recognised in this group. People who were diagnosed with ADHD reported more difficulties in daily functioning and lower quality of life than those without ADHD at the start of the study. Participants with ADHD were followed for up to nine months as part of usual care, without the study influencing treatment decisions. Over time, quality of life and daily functioning improved, particularly for those who received ADHD‑specific treatment such as medication or psychological support. Improvements were seen in areas such as work or daily tasks, mental wellbeing, outlook on life and relationships. The study did not test a new treatment but collected information from real‑world clinical practice. These findings highlight the importance of assessing adults with mental health conditions for ADHD so they can receive appropriate support and care.REC name
London - Queen Square Research Ethics Committee
REC reference
23/LO/0714
Date of REC Opinion
30 Oct 2023
REC opinion
Further Information Favourable Opinion