A Study to Learn About the Occurrence of ADHD in Adults With Mental Conditions and Their Quality of Life (LANDSCAPE)

Takeda

Status: Active, not recruiting

Conditions: Attention Deficit Hyperactivity Disorder (ADHD)

Study type: Observational

Funder types: Industry

Identifiers

NCT04943796

TAK-489-4004

MACS-2020-070101 (Other Identifier)

Details and patient eligibility

About

The main aim of the study is to find out how frequently adults with at least one psychiatric condition have ADHD (but have not been diagnosed with ADHD before) and to describe the quality of life of these adults who have been diagnosed with ADHD. To find out how often ADHD is not diagnosed in these adults could provide awareness about this condition and could help to improve preventing underdiagnosis.

Enrollment: 224 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Part I:

• Adult greater than or equal to (>=)18 years of age or Canadian adult >=19 years of age
• Ability to consent, as judged by the study investigator
• Diagnosis of at least one psychiatric disorder of at least 12 months duration, based on International classification of diseases (ICD)-10 codes registered in electronic health records
• Consecutive assessment for ADHD (as per routine clinical practice)
• Able to read and write in the first language of the respective country

Part II

• Inclusion in study Part I
• Diagnosis of ADHD during Part I, according to routine diagnostic procedure and algorithms
• Anticipated availability for being followed over 9 months

Exclusion criteria

Part I:

• Diagnosis of any of the following at any time prior to signing informed consent: schizoaffective disorder, intellectual disability, or other cognitive disorders
• Occurrence of any of the following events within the 6 months prior to signing consent: psychotic episodes, acute intoxication, or psychotropic drug withdrawal syndrome.
• Diagnosis of ADHD at any time before study inclusion
• Serious and unstable medical condition (severe disease that limits survival to 1 year)
• Participation in a clinical interventional trial in the 12 months prior signing consent

Part II:

• Participant being followed-up for ADHD in a different site

Trial design

224 participants in 2 patient groups

Part I: Participants with ADHD

Description:

Participants with psychiatric disorders undergoing ADHD diagnosis.

Part II: Participants with ADHD

Description:

To collect pseudonymized data from participants who are underdiagnosed of ADHD with psychiatric disorders in daily clinical practice for up to 9 months from both Part I and II.