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
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.
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