Tourette DisorderNCT00416091
Neuropsychological Functioning Among Children With Tourret's Disorder and ADHD
An observational study of Tourette Disorder and Attention-Deficit/Hyperactivity Disorder, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Tourette's disorder (TD) is a childhood-onset neuropsychiatric disorder, manifesting motor and vocal tics with increased likelihood of comorbid with attention-deficit/hyperactivity disorder (ADHD) and other psychiatric disorders. Read more about this study
- Who is it for?
- Ages 8 to 16 years
- Conditions the study is for
- Tourette Disorder, Attention-Deficit/Hyperactivity Disorder
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2007to Dec 2007
- 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 8 to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: Children with ADHD, children with ADHD and Tourette's disorder, normal control
Who may be able to join
- patients aged 8-16 without the diagnosis of ADHD, and/or Tourette's disorder
- IQ > 80
- both children/adolescents and their parents consent to participate and have the ability to complete self-administered measures in this study
Who cannot join
- diagnosis of psychotic disorders, bipolar affective disorders, pervasive developmental disorder, seizure, or major physical disorders.
- in addition, control subjects will be excluded from the control group if have a history of the following condition as defined by DSM-IV: ADHD, ODD, or CD in addition to the above exclusion criteria.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Department of Psychiatry, National Taiwan University Hospital
Taipei, 1002
About this study
Official title: Neuropsychological Functioning, Symptomatology, and Social Adjustment Among Children With Tourret's Disorder, Attention-Deficit/Hyperactivity Disorder, and Comorbid Conditions.
Tourette's disorder (TD) is a childhood-onset neuropsychiatric disorder, manifesting motor and vocal tics with increased likelihood of comorbid with attention-deficit/hyperactivity disorder (ADHD) and other psychiatric disorders. Literature documents the comorbid condition with ADHD predicts an increased functional deficit among individuals with ADHD. The information about neuropsychological functioning among individuals with TD adn/or ADHD is little in Asian population. This study aims to validate the diagnoses of TD, ADHD, and TD comorbid ADHD by symptomatology, neuropsychological measures, and social adjustment. This is a case-control study with a sample of 30 subjects with TD, 60 with ADHD, 30 with TD+ADHD, and 60 controls aged from 6 to 18. All subjects will receive comprehensive assessment including standard psychiatric diagnostic interviews using (K-SADS-E), behavioral assessments (SNAP-IV, CPRS:R-S, CTRS:R-S, CBCL, YBOCS, YGTSS), social adjustment (SAICA, GCAS), parenting (PBI, APGAR) and neuropsychological assessment (CPT, CANTAB, WISC-III). We anticipate that this study will provide the primitive data to validate the TD and ADHD using neuropsychological and clinical measures.
- Keywords
- Tourette disorder, ADHD, comorbidity, neuropsychological
- Medical subject headings
- Tourette Syndrome, Attention Deficit Disorder with Hyperactivity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2006 (estimated)
- Study startJan 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tourette DisorderStudies 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
- Enrolment
- 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, National Taiwan University Hospital & College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00416091
- Sponsor's protocol ID
- 9561706006
- Other IDs
- NTUH96- S558
- Status last verified
- Sep 2008
- First submitted
- 22 Dec 2006
- Last updated
- 14 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Barkley RA (1997), Behavioral inhibition, sustained attention, and executive functions: constructing a unifying theory of ADHD. Psychol Bull 121: 65-94 Channon S, Pratt P, Robertson MM (2003b), Executive function, memory, and learning in Tourette's disorder. Neuropsychology 17: 247-54 Gau SS, Soong WT, Chiu YN, Tsai WC (2006a), Psychometric properties of the Chinese version of the Conners' Teacher and Parent Rating Scales-Revised Short Form. Journal of Attention Disorders. 9: 648-659 Gau SSF, Shen HY, Soong WT, Gau CS (2006b), An open-label, randomized, active controlled equivalent trial of OROS methylphenidate in children with attention-deficit/hyperactivity disorder in Taiwan. Journal of Child and Adolescent Psychopharmacology 16 (in press) Kurlan R, Whitmore D, Irvine C, McDermott MP, Como PG (1994), Tourette's disorder in a special education population: a pilot study involving a single school district. Neurology 44: 699-702
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuropsychological Functioning, Symptomatology, and Social Adjustment Among Children With Tourret's Disorder, Attention-Deficit/Hyperactivity Disorder, and Comorbid Conditions.
- ClinicalTrials.gov ID
- NCT00416091
- Acronym / sponsor ID
- 9561706006
- Keywords
- Tourette disorder, ADHD, comorbidity, neuropsychological
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jan 2007
- Study completion
- Dec 2007 (actual)
- First posted
- 27 Dec 2006 (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.
Tourette's disorder (TD) is a childhood-onset neuropsychiatric disorder, manifesting motor and vocal tics with increased likelihood of comorbid with attention-deficit/hyperactivity disorder (ADHD) and other psychiatric disorders. Literature documents the comorbid condition with ADHD predicts an increased functional deficit among individuals with ADHD. The information about neuropsychological functioning among individuals with TD adn/or ADHD is little in Asian population. This study aims to validate the diagnoses of TD, ADHD, and TD comorbid ADHD by symptomatology, neuropsychological measures, and social adjustment. This is a case-control study with a sample of 30 subjects with TD, 60 with ADHD, 30 with TD+ADHD, and 60 controls aged from 6 to 18. All subjects will receive comprehensive assessment including standard psychiatric diagnostic interviews using (K-SADS-E), behavioral assessments (SNAP-IV, CPRS:R-S, CTRS:R-S, CBCL, YBOCS, YGTSS), social adjustment (SAICA, GCAS), parenting (PBI, APGAR) and neuropsychological assessment (CPT, CANTAB, WISC-III). We anticipate that this study will provide the primitive data to validate the TD and ADHD using neuropsychological and clinical measures.
Study design
- Observational model
- Case-control
Who may qualify
- Ages
- 8 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children with ADHD, children with ADHD and Tourette's disorder, normal control
Key inclusion criteria (3 listed)
- patients aged 8-16 without the diagnosis of ADHD, and/or Tourette's disorder
- IQ > 80
- both children/adolescents and their parents consent to participate and have the ability to complete self-administered measures in this study
Key exclusion criteria (2 listed)
- diagnosis of psychotic disorders, bipolar affective disorders, pervasive developmental disorder, seizure, or major physical disorders.
- in addition, control subjects will be excluded from the control group if have a history of the following condition as defined by DSM-IV: ADHD, ODD, or CD in addition to the above exclusion criteria.
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 14 Nov 2012.
- BackgroundBarkley RA (1997), Behavioral inhibition, sustained attention, and executive functions: constructing a unifying theory of ADHD. Psychol Bull 121: 65-94 Channon S, Pratt P, Robertson MM (2003b), Executive function, memory, and learning in Tourette's disorder. Neuropsychology 17: 247-54 Gau SS, Soong WT, Chiu YN, Tsai WC (2006a), Psychometric properties of the Chinese version of the Conners' Teacher and Parent Rating Scales-Revised Short Form. Journal of Attention Disorders. 9: 648-659 Gau SSF, Shen HY, Soong WT, Gau CS (2006b), An open-label, randomized, active controlled equivalent trial of OROS methylphenidate in children with attention-deficit/hyperactivity disorder in Taiwan. Journal of Child and Adolescent Psychopharmacology 16 (in press) Kurlan R, Whitmore D, Irvine C, McDermott MP, Como PG (1994), Tourette's disorder in a special education population: a pilot study involving a single school district. Neurology 44: 699-702
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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
National Taiwan University Hospital & College of Medicine
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 Tourette Disorder and Attention-Deficit/Hyperactivity Disorder, 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 2 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 14 Nov 2012. 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 NCT00416091, which also lists 1 linked publication.
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 14 Nov 2012.