Inhibition Control of Children and Adolescents With ADHD
Primary Purpose
Attention Deficit Hyperactivity Disorder
Status
Completed
Phase
Locations
Taiwan
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Attention Deficit Hyperactivity Disorder
Eligibility Criteria
Inclusion Criteria:
The inclusion criteria for the subjects are (1)that subjects have a clinical diagnosis of ADHD defined by the DSM-IV which was made by a full-time board-certificated child psychiatrist; (2)their ages range from 10 to 18 when we conduct the study; (3)their IQ greater than 80; and (4)they are under treatment of methylphenidate.
Exclusion Criteria:
The subjects will be excluded from the study if they currently meet criteria or have a history of the following condition as defined by DSM-IV: Schizophrenia, Schizoaffective Disorder, Organic Psychosis, or Pervasive Developmental Disorder.
Sites / Locations
- National Taiwan Univeristy Hospital
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT01677819
First Posted
August 30, 2012
Last Updated
August 30, 2012
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01677819
Brief Title
Inhibition Control of Children and Adolescents With ADHD
Official Title
Inhibition Control of Children and Adolescents With Attention-Deficit/Hyperactivity Disorder
Study Type
Observational
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Taiwan University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The objectives of this study are to investigate:
the effect of methylphenidate on attention;
the relations between methylphenidate and inhibition control and working memory;
the relations between inhibition control and verbal attention and working memory;
the effect of methylphenidate on the changes of neuropsychological functioning and blood pressure.
Detailed Description
Attention deficit hyperactivity disorder (ADHD), characterized by inattention, hyperactivity and impulsivity, is an early onset, highly heritable, clinically heterogeneous, long-term impairing disorder with tremendous impact on individuals, families, and societies. It affects 5-10% of school-aged children worldwide (7.5% in Taiwan). Methylphenidate, a stimulant, is effective in treating these patients. Studies in Taiwan show no effect of methylphenidate on blood pressure. There are evidences show that the change of blood pressure was associated with inhibition of impulsive behaviors. Stop Signal Task(SST) is used to assess the improve of inhibition control after methylphenidate response. By using repeated outcome measurements, we anticipate that this study will evaluate the improvement of neuropsychological performances after medication and determinie the association between medication response and neuropsychological functions and vital signs in a Taiwanese sample.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder
7. Study Design
Enrollment
60 (Actual)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The inclusion criteria for the subjects are (1)that subjects have a clinical diagnosis of ADHD defined by the DSM-IV which was made by a full-time board-certificated child psychiatrist; (2)their ages range from 10 to 18 when we conduct the study; (3)their IQ greater than 80; and (4)they are under treatment of methylphenidate.
Exclusion Criteria:
The subjects will be excluded from the study if they currently meet criteria or have a history of the following condition as defined by DSM-IV: Schizophrenia, Schizoaffective Disorder, Organic Psychosis, or Pervasive Developmental Disorder.
Study Population Description
We will recruit 60 children and adolescents, aged 10 to 18, who are diagnosed with ADHD at the Department of Psychiatry, National Taiwan University Hospital.
Sampling Method
Non-Probability Sample
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan Shur-Fen Gau, MD, PhD
Organizational Affiliation
National Taiwan University Hospital & College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan Univeristy Hospital
City
Taipei
Country
Taiwan
12. IPD Sharing Statement
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Inhibition Control of Children and Adolescents With ADHD
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