Status:
COMPLETED
Stimulant Drug Treatment of Attention-Deficit Hyperactivity Disorder (AD/HD), Inattentive Type
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
ADHD
Eligibility:
All Genders
7-13 years
Phase:
NA
Brief Summary
The purpose of this study is to compare the response to methylphenidate treatment of children with two different subtypes of ADHD.
Detailed Description
The Inattentive subtype (IN) of Attention-Deficit/Hyperactivity Disorder was newly defined in DSM-IV (1994). Recent epidemiological studies suggest that IN is at least as common and as impairing acade...
Eligibility Criteria
Inclusion
- Inattentive Subtype:
- A diagnosis on the structured DISC interview conducted with the parent, of ADHD, Predominantly Inattentive Type.
- Ratings by parent and by teacher corresponding to a total score above the 93rd percentile (i.e. more than 1.5 SD above the mean) on the scale of "DSM-IV Inattention" on the current Conners Parent (or Teacher) Rating Scale - Long Form. The items on this scale are the inattention symptom criteria from the DSM-IV, each of which the informant is asked to rate in severity on a 4-point scale ranging in severity from 0 ("not at all") to 3 ("very much"). A score above the 93th percentile indicates that the child's score equals or exceeds that for 93% of other children of the same age (within 2 years) and gender.
Exclusion
- (a) Scores more than 1 SD (84th percentile) above the mean on the DSM-IV-Hyperactive-Impulsive scale on the Conners Parent or Teacher Rating Scales-Long Form.
- Combined Subtype:
- Inclusion Criteria:
- A diagnosis of ADHD, Combined type on the structured DISC interview with the parent.
- Ratings by parent and teacher each corresponding to a total score above the 93rd percentile (i.e. more than 1.5 SD above the mean) on the scale of "DSM-IV attention" on the current Conners Parent (Teacher) Rating Scales - Long Form.
- Ratings by parent and teacher each corresponding to a total score above the 93rd percentile (i.e. more than 1.5 SD above the mean) on the scale of "DSM-IV Hyperactive-Impulsive" symptoms on the current Conners Parent (Teacher) Rating Scales - Long Form.
- Both Groups:
- Inclusion Criterion: The child's school must agree to administer medication at mid-day and to allow the teacher to complete the requisite behavior ratings.
Key Trial Info
Start Date :
October 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2005
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00824317
Start Date
October 1 2001
End Date
February 1 2005
Last Update
January 16 2009
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Mount Sinai School of Medicine
New York, New York, United States, 10029