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

NCT04943796 | Completed

• 2 other identifiers: TAK-489-4004MACS-2020-070101
• Study Type: observational
• Target: 224
• Locations: 6 countries
• Sites: 14

Brief Summary

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.

Conditions

Attention Deficit Hyperactivity Disorder (ADHD)

Outcome Measures

Primary Outcomes (3)

• Part I: Percentage of Participants With Positive or Negative ADHD Diagnosis

  Percentage of participants with positive or negative ADHD diagnosis will be reported.

  At baseline

• Part II: Change From Baseline in Quality of Life- questionnaire (AAQoL) by Overall Psychological/Psychiatric Clinical Management

  AAQoL (32) is an instrument designed to evaluate the quality of life in ADHD adult participants It has 29 items organized in four domains: Life Productivity (11 items); Psychological Health (6 items), Life Outlook (7 items) and Relationships (5 items). Each item is rated with a five-point Likert scale ranging from 1= Not at all/Never to 5=Extremely/Very Often. Total and domain-specific scores are computed by reversing scores for all items, except those in the Life Outlook domain; transforming all item scores to a 0 to100 point scale (1=0; 2=25; 3=50; 4=75; 5=100); and summing the item scores and dividing by them by item count. Total score ranges from 0 to 100 with higher score representing better quality of life. Change from baseline in AAQoL by overall psychological/psychiatric clinical management will be reported.

  Baseline, 3 Month and 9-Month of follow-up

• Part II: Change From Baseline in AAQoL by ADHD-Specific Clinical Management

  AAQoL (32) is an instrument designed to evaluate the quality of life in ADHD adult participants It has 29 items organized in four domains: Life Productivity (11 items); Psychological Health (6 items), Life Outlook (7 items) and Relationships (5 items). Each item is rated with a five-point Likert scale ranging from 1= Not at all/Never to 5=Extremely/Very Often. Total and domain-specific scores are computed by reversing scores for all items, except those in the Life Outlook domain; transforming all item scores to a 0 to100 point scale (1=0; 2=25; 3=50; 4=75; 5=100); and summing the item scores and dividing by them by item count. Total score ranges from 0 to 100 with higher score representing better quality of life. Change from baseline in AAQoL by ADHD-Specific Clinical Management will be reported.

  Baseline, 3-month, and 9-month follow up

Secondary Outcomes (14)

• Part I: Percentage of Participants With Confirmed Diagnosis of ADHD Based on Adult ADHD Self-Reporting Scale (ASRS)

  At baseline

• Part I: Percentage of Participants With Confirmed Diagnosis of ADHD Based on Diagnostic Interview for Adult ADHD (DIVA 5.0)

  At baseline

• Part I: Percentage of Participants With Confirmed Diagnosis of ADHD Based on Diagnostic and Statistical Manual of Mental Disorders (DSM-5)

  At baseline

• Part II: Number of Modalities for Non-ADHD Psychiatric/Psychological clinical management

  Baseline, 3 Month and 9-Month of follow-up

• Part II: Type of Treatment Given to Participants with ADHD for Non-ADHD Psychiatric/Psychological Clinical Management

  Baseline, 3 Month and 9-Month of follow-up

Study Arms (2)

Part I: Participants with ADHD

Participants with psychiatric disorders undergoing ADHD diagnosis.

Part II: Participants with ADHD

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Participants with diagnosis of any of the following psychiatric disorder: Major depressive disorder (MDD), Anxiety disorders (AD), Bipolar disorders (BD), Substance use disorders (SUD), Border line disorder and Binge eating disorder.

You may qualify if:

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

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Takeda: lead

Study Sites (14)

Pacific Coast Recovery Care

Burnaby, British Columbia, V3N3N4, Canada

Location

Hopital de Psychiatrie de Trois-Rivières, Pavillon St-Joseph

Trois-Rivières, Quebec, G9A 5Z9, Canada

Location

Regina Mental Wellness Clinic

Regina, Saskatchewan, S4P0W6, Canada

Location

Charité - Universitätsmedizin Berlin

Berlin, 10117, Germany

Location

Klinik und Poliklinik für Psychiatrie und Psychoterapie

Bonn, 53127, Germany

Location

Universitätsklinikum Frankfurt am Main

Frankfurt am Main, 60596, Germany

Location

Asklepios Klinikum Hamburg

Hamburg, 21075, Germany

Location

Hospital Vall d'Hebron

Barcelona, 08035, Spain

Location

Clínica Dr. Quintero

Madrid, 28002, Spain

Location

Hs. Infanta Elena

Madrid, 28342, Spain

Location

Psykiatrisk klinik Umeå

Umeå, 907 37, Sweden

Location

University Hospitals of Geneva

Geneva, 1205, Switzerland

Location

Cumbria Northumb, Tyne & Wear FT, Adult Psychiatry Dept

Newcastle upon Tyne, NE3 3XT, United Kingdom

Location

Tees Esk and Wear Valley foundation

York, YO31 8TA, United Kingdom

Location

Related Links

• To obtain more information on the study, click here/on this link

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2021
• First Posted: June 29, 2021
• Study Start: November 6, 2023
• Primary Completion: July 28, 2025
• Study Completion: July 28, 2025
• Last Updated: October 14, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

Locations

SE (1); CH (1); CA (3); DE (4); ES (3); GB (2)