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

NCT ID: NCT04943796

Last Updated: 2025-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

224 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-11-06

Study Completion Date

2025-07-28

Brief Summary

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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.

Detailed Description

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Conditions

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Attention Deficit Hyperactivity Disorder (ADHD)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Part I: Participants with ADHD

Participants with psychiatric disorders undergoing ADHD diagnosis.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Takeda

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Study Director

Role: STUDY_DIRECTOR

Takeda

Locations

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Pacific Coast Recovery Care

Burnaby, British Columbia, Canada

Site Status

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

Trois-Rivières, Quebec, Canada

Site Status

Regina Mental Wellness Clinic

Regina, Saskatchewan, Canada

Site Status

Charité - Universitätsmedizin Berlin

Berlin, , Germany

Site Status

Klinik und Poliklinik für Psychiatrie und Psychoterapie

Bonn, , Germany

Site Status

Universitätsklinikum Frankfurt am Main

Frankfurt am Main, , Germany

Site Status

Asklepios Klinikum Hamburg

Hamburg, , Germany

Site Status

Hospital Vall d'Hebron

Barcelona, , Spain

Site Status

Clínica Dr. Quintero

Madrid, , Spain

Site Status

Hs. Infanta Elena

Madrid, , Spain

Site Status

Psykiatrisk klinik Umeå

Umeå, , Sweden

Site Status

University Hospitals of Geneva

Geneva, , Switzerland

Site Status

Cumbria Northumb, Tyne & Wear FT, Adult Psychiatry Dept

Newcastle upon Tyne, , United Kingdom

Site Status

Tees Esk and Wear Valley foundation

York, , United Kingdom

Site Status

Countries

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Canada Germany Spain Sweden Switzerland United Kingdom

Related Links

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https://clinicaltrials.takeda.com/study-detail/60dc8cc1ef0b71001e743dfc

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

Other Identifiers

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MACS-2020-070101

Identifier Type: OTHER

Identifier Source: secondary_id

TAK-489-4004

Identifier Type: -

Identifier Source: org_study_id

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