Clinical and Neuropsychological Validity of Attention-Deficit Hyperactivity Disorder in Adulthood

September 1, 2021 updated by: National Taiwan University Hospital
This study aims to establish the psychometric properties of the Adult ADHD Quality of Life Scale (AAQoL) and to validate the diagnosis of adult ADHD by ADHD symptoms, other clinical psychiatric symptoms, neuropsychological functioning, social/family/occupational functioning, and intervention effect.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

Attention-deficit/hyperactivity disorder (ADHD) is a common (5-10%) childhood-onset neuropsychiatric disorder worldwide among children and adolescents with 50- 60% persistence to adulthood (3-4%). Western studies have revealed a wide range of family/social/occupational impairment and neurocognitive deficits in adults with ADHD. However, there is limited data on the treatment effect for adults with ADHD worldwide and there is lack of information about adult ADHD in Taiwan. In view of this, it is warranted to conduct a study on the clinical, functional, and neurocognitive aspects of adult ADHD in Taiwanese population.

This study consists of two parts: (1) a community survey among 1000 adults to establish the validity of AAQoL; and (2) a case-control study with a sample of 60 adults, aged 18-50, with DSM-IV ADHD and 60 healthy controls matching for the age and sex structure of the ADHD group. The instruments include a standard psychiatric diagnostic interviews using (K-SADS-E), self-administered rating scales for assessing psychopathology (ASRI), ADHD symptoms (ASRS, CGI-ADHD-S,), social and family functions (AAQoL, SDS, Moos dyadic assessment, family APGAR, GDS) and neuropsychological assessment (WAIS-III, CANTAB). The ADHD group will be reassessed for symptom severity and neuropsychological functioning 2-3 months (ranging from 8 to 12 weeks) after the first assessment.

We anticipate that this study will provide the primitive data on the symptomatology, neuropsychological functions, quality of life, and social/family function of adult patients with ADHD, will evaluate the treatment response of medication or psychosocial intervention in the aspects of symptomatology, neuropsychological functions, quality of life, and family function; and young psychiatric researchers will learn to conduct standardized psychiatric interview and neuropsychological tests, and to collect data, conduct statistical analysis, and prepare the manuscript. Our findings should have clinical implication in assessing and treating adult patients with ADHD and provide the preliminary data for future brain imaging, neurocognitive, and interventional studies on adult ADHD.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 10002
        • National Taiwan University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

community sample & clinical sample

Description

Inclusion Criteria:

  • Case group:

Case group I: The cases with childhood ADHD diagnosis diagnosed as ADHD after interview Case group II: The cases with sufficient ADHD symptoms for diagnosis as DSM-IV ADHD at childhood but never assessed or treated for ADHD in childhood

  • Control group：The subjects without the DSM-IV-TR diagnosis of ADHD or any major psychiatric disorders.

Exclusion Criteria:

  • Comorbid with DSM-IV-TR diagnosis of pervasive developmental disorder, schizophrenia, schizoaffective disorder, delusional disorder, other psychotic disorder, organic psychosis, schizotypal personality disorder, bipolar affective disorder, severe anxiety disorder(such as OCD, ASD or PTSD) and mental retardation.
  • In the major depressive episode, comorbid with severe anxiety disorders or during substance intoxication or withdrawal at the time of evaluation.
  • With neurodegenerative disorder, epilepsy, involuntary movement disorder, congenital metabolic disorder, brain tumor, history of severe head trauma, and history of craniotomy.
  • With visual or hearing impairments, or motor disability which may influence the process of neuropsychological assessment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Taiwan University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Susan Shur-Fen Gau, MD, PhD, Dept of Psychiatry, National Taiwan University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2007

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 29, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 29, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 30, 2007

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 2, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 1, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 200705065R

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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