Clinical trial NCT04943796: A Study to Learn About the Occurrence of ADHD in Adults With Mental Conditions and Their Quality of Life
Official title: Prevalence of ADHD and Health Outcomes in Adult Outpatients With Psychiatric Disorders: a Multi-country, Two-part, Observational Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Attention Deficit Hyperactivity Disorder (ADHD)
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2021-06-29
Enrollment: 224
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Part I: Percentage of Participants With Positive or Negative ADHD Diagnosis
timeFrame: At baseline
measure: Part II: Change From Baseline in Quality of Life- questionnaire (AAQoL) by Overall Psychological/Psychiatric Clinical Management
timeFrame: Baseline, 3 Month and 9-Month of follow-up
measure: Part II: Change From Baseline in AAQoL by ADHD-Specific Clinical Management
timeFrame: Baseline, 3-month, and 9-month follow up
Secondary outcomes:
measure: Part I: Percentage of Participants With Confirmed Diagnosis of ADHD Based on Adult ADHD Self-Reporting Scale (ASRS)
timeFrame: At baseline
measure: Part I: Percentage of Participants With Confirmed Diagnosis of ADHD Based on Diagnostic Interview for Adult ADHD (DIVA 5.0)
timeFrame: At baseline
measure: Part I: Percentage of Participants With Confirmed Diagnosis of ADHD Based on Diagnostic and Statistical Manual of Mental Disorders (DSM-5)
timeFrame: At baseline
measure: Part II: Number of Modalities for Non-ADHD Psychiatric/Psychological clinical management
timeFrame: Baseline, 3 Month and 9-Month of follow-up
measure: Part II: Type of Treatment Given to Participants with ADHD for Non-ADHD Psychiatric/Psychological Clinical Management
timeFrame: Baseline, 3 Month and 9-Month of follow-up
measure: Part II: Duration of Treatment for Non-ADHD Psychiatric/Psychological Clinical Management
timeFrame: Baseline, 3 Month and 9-Month of follow-up
measure: Part II: Number of Modalities for ADHD-specific Psychiatric/Psychological Clinical Management
timeFrame: Baseline, 3 Month and 9-Month of follow-up
measure: Part II: Type of Treatment Given to Participants with ADHD for ADHD-Specific Overall Psychiatric/Psychological Clinical Management
timeFrame: Baseline, 3 Month and 9-Month of follow-up
measure: Part II: Duration of Treatment for ADHD-Specific Psychiatric/Psychological Clinical Management
timeFrame: Baseline, 3 Month and 9-Month of follow-up
measure: Part II: Change From Baseline in Functional Assessment Short Test (FAST) Score
timeFrame: Baseline, 3 Month and 9-Month of follow-up
measure: Part II: Change From Baseline in Clinical Global Impressions Scale- Severity of Illness (CGI-S)
timeFrame: Baseline, 3 Month and 9-Month of follow-up
measure: Part II: Change From Baseline in Clinical Global Impressions Scale- Improvement (CGI-I) Score
timeFrame: Baseline, 3 Month and 9-Month of follow-up
measure: Change From Baseline in Health Resource Utilization (HRU)
timeFrame: Baseline, 3 Month and 9-Month of follow-up
measure: Part II: Functionality Level and Quality of Life by ADHD-Specific Clinical Management
timeFrame: Baseline, 3-month, and 9-month follow up
Other outcomes:
Locations:
city: Burnaby
country: Canada
facility: Pacific Coast Recovery Care
state: British Columbia
city: Trois-Rivières
country: Canada
facility: Hopital de Psychiatrie de Trois-Rivières, Pavillon St-Joseph
state: Quebec
city: Regina
country: Canada
facility: Regina Mental Wellness Clinic
state: Saskatchewan
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin
city: Bonn
country: Germany
facility: Klinik und Poliklinik für Psychiatrie und Psychoterapie
city: Frankfurt am Main
country: Germany
facility: Universitätsklinikum Frankfurt am Main
city: Hamburg
country: Germany
facility: Asklepios Klinikum Hamburg
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebron
city: Madrid
country: Spain
facility: Clínica Dr. Quintero
city: Madrid
country: Spain
facility: Hs. Infanta Elena
city: Umeå
country: Sweden
facility: Psykiatrisk klinik Umeå
city: Geneva
country: Switzerland
facility: University Hospitals of Geneva
city: Newcastle upon Tyne
country: United Kingdom
facility: Cumbria Northumb, Tyne & Wear FT, Adult Psychiatry Dept
city: York
country: United Kingdom
facility: Tees Esk and Wear Valley foundation
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: