A Study on How Often Adults With Psychiatric Conditions Who Did Not Respond To Treatment Are Underdiagnosed as Having ADHD (LANDSCAPE)

• ClinicalTrials.gov Identifier: NCT04943796
• Recruitment Status: Not yet recruiting
• First Posted: June 29, 2021
• Last Update Posted: August 23, 2022
• Sponsor: Takeda
• Information provided by (Responsible Party): Takeda

Tracking Information

• First Submitted Date: June 28, 2021
• First Posted Date: June 29, 2021
• Last Update Posted Date: August 23, 2022
• Estimated Study Start Date: June 1, 2023
• Estimated Primary Completion Date: April 1, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 28, 2021)

• Percentage of Participants With Confirmed Diagnosis of ADHD Based on Adult ADHD Self-Reporting Scale (ASRS) [ Time Frame: At baseline ]
  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 and inadequate response to current treatment based on adult ASRS will be reported.
• Percentage of Participants With Confirmed Diagnosis of ADHD Based on Diagnostic Interview for Adult ADHD (DIVA 5.0) [ Time Frame: At baseline ]
  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 and inadequate response to current treatment based on DIVA 5.0 will be reported.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: June 28, 2021)

• Number of Participants Diagnosis of ADHD per Psychiatric Disorder [ Time Frame: At baseline ]
  Psychiatric disorder will include major depressive disorder (MDD), anxiety disorders (AD), bipolar disorders (BD) and Substance use disorders (SUD).
• Change From Baseline in Functional Assessment Short Test (FAST) Score [ Time Frame: Baseline up to end of follow-up (Month 6) ]
  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).
• Change From Baseline in Health Resource Utilization (HRU) [ Time Frame: From 6 months prior inclusion to baseline up to end of follow-up (Month 6) ]
  HRU before the diagnosis of ADHD in participants with ADHD diagnosis confirmed at baseline will be assessed.
• Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire [ Time Frame: Last 7 days prior to Baseline up to end of follow-up (Month 6) ]
  WPAI is a 6-item questionnaire scale used to measure lost work productivity and impairment in daily activities over the past seven days. It will be analyzed using the responses to the WPAI-GH questionnaire in participants actively working in the last 7 days. The WPAI yields four types of scores: 1. Absenteeism 2. Presenteesism 3. Work productivity loss 4. Activity Impairment, ranging from 0-100. Higher numbers indicate greater impairment and less productivity. The questionnaire will be implemented only one time per person in the study duration.
• Number of Participants with Treatment Management Before and After the ADHD Diagnosis [ Time Frame: From 6 months prior to baseline up to end of follow-up (Month 6) ]
  Number of participants with treatment management of participants with ADHD diagnosis confirmed at baseline visit before and after the ADHD diagnosis will be reported.
• Number of Participants Categorized by Sociodemographic Variables [ Time Frame: At baseline ]
  Sociodemographic data will be collected after randomization. Sociodemographic variables will include age (age of the participant at the time of the visit will be recorded), gender (man/woman), ethnicity (Caucasian/Hispanic/African/Asian/Other/Unknown), education (ongoing or completed level of education will be recorded), employment status (employed, self-employed, employed but on sick leave due to the study disease, permanent incapacity to work due to the study disease, permanent incapacity to work due to other reasons, student, unemployed, retired, domestic work, other), marital status (Married/with partner, divorced/separated, unmarried, widow/er).
• Number of Participants Categorized by Clinical Characteristics on Diagnosis [ Time Frame: At baseline ]
  Clinical characteristics will include physical examination (weight, height, BMI), smoking status (smoker, ex-smoker, non-smoker, unknown), drugs (occasional use; frequent use; regular use), alcohol intake (heavy drinker, occasional drinker, abstinent, unknown), exercise status (never, regular, frequently), family history related to ADHD (parent/sibling with ADHD, childhood symptoms of ADHD), suicide attempts, number of hospitalizations related to the psychiatric diseases in the previous 6 months.
• Change From Baseline in Clinical Global Impressions Scale- Improvement (CGI-I) Score [ Time Frame: Baseline up to end of follow-up (Month 6) ]
  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.
• Change From Baseline in Clinical Global Impressions Scale- Severity of Illness (CGI-S) [ Time Frame: Baseline up to end of follow-up (Month 6) ]
  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.
• Time for First Psychiatric Disorder to ADHD Diagnosis [ Time Frame: At baseline ]
  Time for first psychiatric disorder to ADHD diagnosis will be reported.
• Change from Baseline in Behavior Rating Inventory of Executive Function- Adult Version (BRIEF-A) [ Time Frame: Baseline up to end of follow-up (Month 6) ]
  BRIEF-A is a patient-reported scale to measure various aspects of adult executive functioning and self-regulation in the person's everyday environment. 75 items that participant's rate on a 3-point Likert scale (1 = behavior is never observed to 3 = behavior is often observed). Higher scores indicate greater impairment in executive functioning. Nine non-overlapping subscales. Four of them (Inhibit, Shift, Emotional Control, Self-Monitor) combine to yield the BRI. The remaining five (Initiate, Working Memory, Plan/Organize, Task Monitor, Organization of Materials) combine to yield the MI. The two indices combine to yield the total score, called the GEC score.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study on How Often Adults With Psychiatric Conditions Who Did Not Respond To Treatment Are Underdiagnosed as Having ADHD
• Official Title: Observational, Multicentre, Prospective Study to Assess ADHD In Adult Patients With Inadequate Response to Treatments For Other Resistant Psychiatric Pathologies In Five Countries

Brief Summary

The main aim of this study is to find out how many adults with certain psychiatric conditions who didn't respond to their current treatment are underdiagnosed as having ADHD.

No study medicines will be provided to participants in this study. The study sponsor will not be involved in how participants are treated but will provide instructions on how the clinics will record what happens during the study.

At their first clinic visit, the diagnosis of ADHD will be confirmed or not confirmed by the study doctor. Participants without confirmed ADHD will leave the study after the first visit. Participants with confirmed ADHD will visit their clinic 2 more times during this study (three visits in total). During these visits, they will complete a questionnaire and have an interview with the study doctor about their condition.

• Detailed Description: Observational, multicentre, prospective study to assess ADHD in adult patients with inadequate response to treatments for other resistant psychiatric pathologies in five countries
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Probability Sample
• Study Population: Participants with diagnosis of any of the following psychiatric disorder: MDD, AD, BD and SUD with inadequate response to current treatment.
• Condition: Attention Deficit Hyperactivity Disorder (ADHD)
• Intervention: Not Provided

Study Groups/Cohorts

Participants with ADHD

To collect information from participants who are underdiagnosed of ADHD with psychiatric disorders in daily clinical practice for up to 9 months.

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: June 28, 2021): 475
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: April 1, 2024
• Estimated Primary Completion Date: April 1, 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Participant of age greater than equal to (>=) 18.
• Participant with confirmed diagnosis (psychiatric disease of at least 12 months) of one or more psychiatric pathologies, including MDD, AD, BD and SUD.
• Participant attended in out-patient clinic.
• Participant who presents insufficient or inadequate response (who has received at least with two different treatments at minimum doses according to SmPC and with CGI-S score >= 4 [moderate ill]) to previous treatment.
• Participant capable of understanding and complying with protocol requirements, in the opinion of the investigator.
• Participant capable to fulfill the study questionnaires.
• Participant with English knowledge to complete the study questionnaires, if necessary.
• Participant or, when applicable, the participant's legally acceptable representative, who signs and dates a written informed consent form and any required privacy authorization prior to the initiation of any study procedures.

Exclusion Criteria:

• Participant with previous ADHD diagnosis and/or who had received previous pharmacological treatment for it.
• Participant with diagnosis of schizoaffective disorder, mental retardation or other cognitive disorders.
• Participant with presence of psychotic symptoms during the current episode.
• Psychiatric disorder exacerbation, acute intoxication or psychotropic drug withdrawal syndrome.
• Participant with a serious and unstable medical condition.
• Participant who has participated in a clinical trial in the past 12 months (Clinical trial participation could be cause of bias regarding healthcare resource use data collection).

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Takeda Contact; +1-877-825-3327; medinfoUS@takeda.com

• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT04943796
• Other Study ID Numbers: TAK-489-4004; MACS-2020-070101 ( Other Identifier: Takeda )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: 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.
• Supporting Materials: Study Protocol
• Supporting Materials: Statistical Analysis Plan (SAP)
• Supporting Materials: Informed Consent Form (ICF)
• Supporting Materials: Clinical Study Report (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.
• URL: https://vivli.org/ourmember/takeda/

• Current Responsible Party: Takeda
• Original Responsible Party: Same as current
• Current Study Sponsor: Takeda
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Study Director; Takeda

• PRS Account: Takeda
• Verification Date: August 2022