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Attention Deficit Hyperactivity Disorder (ADHD)LANDSCAPENCT04943796

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

An observational study of Attention Deficit Hyperactivity Disorder (ADHD), run by Takeda at 14 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
How many people
224 participants
Where
14 sitesin 6 countries
Study dates
6 Nov 2023to 28 Jul 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

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

Who cannot join

  • 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 locations and contacts

14 sites in 6 countries.

14 sites in 6 countries

Germany4 sites
  • Charité - Universitätsmedizin Berlin

    Berlin, 10117

  • Klinik und Poliklinik für Psychiatrie und Psychoterapie

    Bonn, 53127

  • Universitätsklinikum Frankfurt am Main

    Frankfurt am Main, 60596

  • Asklepios Klinikum Hamburg

    Hamburg, 21075

Other trials in Germany

Canada3 sites
  • Pacific Coast Recovery Care

    Burnaby, British Columbia, V3N3N4

  • Regina Mental Wellness Clinic

    Regina, Saskatchewan, S4P0W6

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

    Trois-Rivières, Quebec, G9A 5Z9

Other trials in Canada

Spain3 sites
  • Hospital Vall d'Hebron

    Barcelona, 08035

  • Clínica Dr. Quintero

    Madrid, 28002

  • Hs. Infanta Elena

    Madrid, 28342

Other trials in Spain

United Kingdom2 sites
  • Cumbria Northumb, Tyne & Wear FT, Adult Psychiatry Dept

    Newcastle upon Tyne, NE3 3XT

  • Tees Esk and Wear Valley foundation

    York, YO31 8TA

Other trials in United Kingdom

Sweden1 site
  • Psykiatrisk klinik Umeå

    Umeå, 907 37

Other trials in Sweden

Switzerland1 site
  • University Hospitals of Geneva

    Geneva, 1205

Other trials in Switzerland

About this study

Official title: Prevalence of ADHD and Health Outcomes in Adult Outpatients With Psychiatric Disorders: a Multi-country, Two-part, Observational Study

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.

Medical subject headings
Attention Deficit Disorder with Hyperactivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04943796
Study groupRoleWhat they receive
Part I: Participants with ADHDParticipants with psychiatric disorders undergoing ADHD diagnosis.
Part II: Participants with ADHDTo 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: At baseline

  2. 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.

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

  3. 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.

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

Secondary outcomes (14)
  1. Part I: Percentage of Participants With Confirmed Diagnosis of ADHD Based on Adult ADHD Self-Reporting Scale (ASRS)

    ASRS is designed to evaluate for severity of symptoms as specified in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5). ASRS is composed of 18 questions, and uses a scale that ranges from 0-4 based on the individuals mark in either the "never, rarely, sometimes, often, very often" column for a possible total score of 72. The minimum score to qualify for study inclusion is 8 (i.e. 4 or more "symptom-positive" answers), and the maximum possible score is 72. The higher the score, the more indicative of higher severity of ADHD symptoms. Each column is used to describe the severity of the individuals symptoms based on the questions asked. Each participant is asked to make a mark within one column for each question that best describes their answer. Percentage of participants with confirmed diagnosis of ADHD in participants with psychiatric disorder based on adult ASRS will be reported.

    Measured: At baseline

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

    DIVA 5.0 is a structured diagnostic interview for Adult ADHD, and is based on the criteria for ADHD in DSM-5. Whenever possible the DIVA should be completed with adults in the presence of a partner and/or family member, to enable retrospective and collateral information to be ascertained at the same time. The DIVA usually takes around one and a half hours to complete. The DIVA only asks about the core symptoms of ADHD required to make the DSM-IV diagnosis of ADHD, and does not ask about other co-occurring psychiatric symptoms, syndromes or disorders. In this study, participant will be interviewed using DIVA only if scores in ASRS showed positive diagnosis of ADHD.

    Percentage of participants with confirmed diagnosis of ADHD in participants with psychiatric disorder based on DIVA 5.0 will be reported.

    Measured: At baseline

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

    DSM-5 confirm the diagnosis of ADHD if meeting all of the following criteria: (i) having five out of nine ADHD inattention and/or hyperactivity/impulsivity symptoms for the last 6 months or more; (ii) having several symptoms before the 12 years of age; (iii) having several symptoms in at least two settings (e.g., at home or work; and with friends or family members); (iv) having symptoms interfering with quality of social, academic, or occupational functioning; and (v) having symptoms that do not occur exclusively during the course of a psychotic disorder and are not better explained by another mental disorder.

    Percentage of participants with confirmed diagnosis of ADHD in participants with psychiatric disorder based on DSM-5 will be reported.

    Measured: At baseline

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

    Number of modalities for non-ADHD psychiatric/psychological clinical management will be assessed.

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

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

    Type of treatment given to participants with ADHD for non-ADHD psychiatric/psychological clinical management will be assessed.

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

  6. Part II: Duration of Treatment for Non-ADHD Psychiatric/Psychological Clinical Management

    Duration of treatment for non-ADHD psychiatric/psychological clinical management will be assessed.

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

  7. Part II: Number of Modalities for ADHD-specific Psychiatric/Psychological Clinical Management

    Number of modalities for ADHD-specific psychiatric/psychological clinical management will be assessed.

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

  8. Part II: Type of Treatment Given to Participants with ADHD for ADHD-Specific Overall Psychiatric/Psychological Clinical Management

    Type of treatment given to participants with ADHD for ADHD-specific overall psychiatric/psychological clinical management will be assessed.

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

  9. Part II: Duration of Treatment for ADHD-Specific Psychiatric/Psychological Clinical Management

    Duration of treatment for ADHD-specific psychiatric/psychological clinical management will be assessed.

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

  10. Part II: Change From Baseline in Functional Assessment Short Test (FAST) Score

    FAST is a brief instrument designed to assess the main functioning problems experienced by psychiatric participants, particularly bipolar participants. It comprises 24 items that assess impairment or disability in six specific areas of functioning: autonomy, occupational functioning, cognitive functioning, financial issues, interpersonal relationships and leisure time. The scale used to evaluate functionality is the FAST Scale, the minimum value being 0 and maximum value of 72, domain scores are scaled in a negative direction (i.e. lower scores denote higher functionality).

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

  11. Part II: Change From Baseline in Clinical Global Impressions Scale- Severity of Illness (CGI-S)

    CGI-S is a 7-point scale to rate the participant's severity of illness at the time of assessment, relative to the clinician's past experience with participants who have the same diagnosis by means of one question: Considering your total clinical experience with this particular population, how mentally ill is the participant at this time which is rated on the following seven-point scale with range from 1 to 7 were: 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill participants.

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

  12. Part II: Change From Baseline in Clinical Global Impressions Scale- Improvement (CGI-I) Score

    CGI-I is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention: Compared to the participant's condition at admission to the project [prior to medication initiation], this participant's condition ranges from 1 to 7 were: 1=very much improved since the initiation of treatment; 2=much improved; 3=minimally improved; 4=no change from baseline (the initiation of treatment); 5=minimally worse; 6= much worse; 7=very much worse since the initiation of treatment.

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

  13. Change From Baseline in Health Resource Utilization (HRU)

    Utilization of health resources by the study population during the 12 months prior ADHD assessment in the total sample and according to the diagnosis will be assessed at baseline, 3-months and 9 months follow up.

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

  14. Part II: Functionality Level and Quality of Life by ADHD-Specific Clinical Management

    Continues variables (e.g., age, functionality scores, quality of life scores, number of previous visits to the hospital) and categorical variables (e.g., sex, clinical characteristics, psychiatric disorders, ADHD warning signs, treatments, previous tests) will be described in the total sample and according to confirmed/no confirmed ADHD; and will be compared using T-test or ANOVA test (continues variables) and Chi squared test (categorical variables).

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jun 2021
  2. Study start6 Nov 2023
  3. Primary completion28 Jul 2025
  4. Study completion28 Jul 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
224 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04943796
Sponsor's protocol ID
TAK-489-4004
Other IDs
MACS-2020-070101
Acronym
LANDSCAPE
Status last verified
Oct 2025
First submitted
28 Jun 2021
Last updated
14 Oct 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

Questions about this trial

What is this clinical trial studying?

An observational study of Attention Deficit Hyperactivity Disorder (ADHD), run by Takeda at 14 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in Germany, Canada, Spain, United Kingdom, Sweden and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part I: Percentage of Participants With Positive or Negative ADHD Diagnosis (time frame: At baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2025.

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