Attention Deficit Disorder With HyperactivityNCT00550667
Clinical and Neuropsychological Validity of Attention-Deficit Hyperactivity Disorder in Adulthood
An observational study of Attention Deficit Disorder With Hyperactivity, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention Deficit Disorder With Hyperactivity
- How many people
- 1,120 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Oct 2007to 30 Jun 2013
- 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 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: community sample \& clinical sample
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Keywords
- Attention-deficit hyperactivity disorder, adult, diagnostic validity, neuropsychological functions, social functioning
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Social Adjustment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2007 (estimated)
- Study start1 Oct 2007
- Primary completion30 Jun 2013
- Study completion30 Jun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Disorder With HyperactivityStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Case-control
- Time perspective
- Other
- Enrolment
- 1,120 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Susan Shur-Fen Gau, MD, PhD, Principal investigator, Dept of Psychiatry, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00550667
- Sponsor's protocol ID
- 200705065R
- Status last verified
- Sep 2021
- First submitted
- 29 Oct 2007
- Last updated
- 2 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Candido RCF, Menezes de Padua CA, Golder S, Junqueira DR. Immediate-release methylphenidate for attention deficit hyperactivity disorder (ADHD) in adults. Cochrane Database Syst Rev. 2021 Jan 18;1(1):CD013011. doi: 10.1002/14651858.CD013011.pub2.
PubMed 33460048Ni HC, Shang CY, Gau SS, Lin YJ, Huang HC, Yang LK. A head-to-head randomized clinical trial of methylphenidate and atomoxetine treatment for executive function in adults with attention-deficit hyperactivity disorder. Int J Neuropsychopharmacol. 2013 Oct;16(9):1959-73. doi: 10.1017/S1461145713000357. Epub 2013 May 14.
PubMed 23672818
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Neuropsychological Validity of Attention-Deficit Hyperactivity Disorder in Adulthood
- ClinicalTrials.gov ID
- NCT00550667
- Acronym / sponsor ID
- 200705065R
- Keywords
- Attention-deficit hyperactivity disorder, adult, diagnostic validity, neuropsychological functions, social functioning
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,120 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Oct 2007 (actual)
- Primary completion
- 30 Jun 2013 (actual)
- Study completion
- 30 Jun 2013 (actual)
- First posted
- 30 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- community sample \& clinical sample
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2021.
- Derived from this study: PubMed 33460048Candido RCF, Menezes de Padua CA, Golder S, Junqueira DR. Immediate-release methylphenidate for attention deficit hyperactivity disorder (ADHD) in adults. Cochrane Database Syst Rev. 2021 Jan 18;1(1):CD013011. doi: 10.1002/14651858.CD013011.pub2.
- Derived from this study: PubMed 23672818Ni HC, Shang CY, Gau SS, Lin YJ, Huang HC, Yang LK. A head-to-head randomized clinical trial of methylphenidate and atomoxetine treatment for executive function in adults with attention-deficit hyperactivity disorder. Int J Neuropsychopharmacol. 2013 Oct;16(9):1959-73. doi: 10.1017/S1461145713000357. Epub 2013 May 14.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan Shur-Fen Gau, MD, PhD principal investigator
Dept of Psychiatry, National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Attention Deficit Disorder With Hyperactivity, run by National Taiwan University Hospital at 1 site in Taiwan.
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 3 inclusion and 4 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 2 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00550667, which also lists 2 linked publications.
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 2 Sep 2021.