- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00550667
Clinical and Neuropsychological Validity of Attention-Deficit Hyperactivity Disorder in Adulthood
Study Overview
Status
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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Taipei, Taiwan, 10002
- National Taiwan University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
How is the study designed?
Design Details
Collaborators and Investigators
Investigators
- Principal Investigator: Susan Shur-Fen Gau, MD, PhD, Dept of Psychiatry, National Taiwan University Hospital
Publications and helpful links
General 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.
- Ni 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 200705065R
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Clinical Trials on Attention Deficit Disorder With Hyperactivity
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Ornit CohenUnknownAttention Deficit Hyperactivity Disorder | Attention Deficit Disorder With Hyperactivity | Attention Deficit Disorder | Attention Deficit Disorders With Hyperactivity | Attention Deficit Hyperactivity DisordersIsrael
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Cingulate TherapeuticsRecruitingPhase 3 Efficacy and Safety Laboratory Classroom Study in Pediatrics (6-12) With ADHD Using CTx-1301ADHD | Attention Deficit Hyperactivity Disorder | Attention Deficit Disorder With Hyperactivity | ADHD - Combined Type | Attention Deficit Hyperactivity Disorder Combined | Attention Deficit Hyper Activity | Attention-deficit HyperactivityUnited States
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Karolinska InstitutetCompletedAttention Deficit Disorder With Hyperactivity (ADHD)Sweden
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Rabin Medical CenterNG Solutions LtdRecruitingADHD - Attention Deficit Disorder With HyperactivityIsrael
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Fondation LenvalCompletedAttention Deficit Disorder With Hyperactivity | Attention Deficit Disorder Without HyperactivityFrance
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Clinical and Translational Genome Research Institute...Children's Specialized HospitalTerminatedAttention Deficit Disorders With HyperactivityUnited States
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University of PennsylvaniaCompletedAttention Deficit Disorder With Hyperactivity (ADHD)United States
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Nemours Children's ClinicCompletedAttention Deficit Hyperactivity Disorder | Attention Deficit Disorder With Hyperactivity | Attention Deficit DisorderUnited States
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Massachusetts General HospitalRecruitingAttention Deficit Disorder With Hyperactivity | Attention Deficit DisorderUnited States
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New River PharmaceuticalsShireCompletedAttention Deficit Hyperactivity Disorder | Attention Deficit Disorders With Hyperactivity | Attention Deficit Hyperactivity DisordersUnited States