Trial Outcomes & Findings for Long Acting Stimulant Treatment of Attention Deficit Hyperactivity Disorder (ADHD) in Young Children (NCT NCT00754208)
NCT ID: NCT00754208
Last Updated: 2023-10-05
Results Overview
Change from baseline to endpoint of investigator-scored, parent version of the Attention Deficit Hyperactivity Disorder Rating Scale-IV (ADHD-IV rating scale). The ADHD-IV contains 18 items, and each item is rated 0, 1, 2 or 3. Minimum score is 0. Maximum score is 54. Change in score represents the difference between the total score at end point compared to the total score at baseline. Higher scores indicate greater symptom severity.
COMPLETED
PHASE4
7 participants
8 weeks
2023-10-05
Participant Flow
Recruitment occurred from September 2008 through Deceber 2009 in an academic medical center.
Please see inclusion and exclusion criteria.
Participant milestones
| Measure |
Ritalin LA for ADHD
Subjects treated with Ritalin LA for ADHD
|
|---|---|
|
Overall Study
STARTED
|
7
|
|
Overall Study
COMPLETED
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Long Acting Stimulant Treatment of Attention Deficit Hyperactivity Disorder (ADHD) in Young Children
Baseline characteristics by cohort
| Measure |
Ritalin LA for ADHD
n=7 Participants
4 and 5 year old subjects with ADHD
|
|---|---|
|
Age, Categorical
<=18 years
|
7 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
4 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
7 Participants
n=5 Participants
|
|
ADHD Subtype
ADHD, combined subtype
|
7 Participants
n=5 Participants
|
|
ADHD Subtype
ADHD, inattentive subtype
|
0 Participants
n=5 Participants
|
|
ADHD Subtype
ADHD, hyperactive/impulsive subtype
|
0 Participants
n=5 Participants
|
|
Comorbid Oppositional Defiant Disorder
YES
|
4 Participants
n=5 Participants
|
|
Comorbid Oppositional Defiant Disorder
NO
|
3 Participants
n=5 Participants
|
|
Prior Treatment
Individual therapy
|
2 Participants
n=5 Participants
|
|
Prior Treatment
Pharmacotherapy
|
0 Participants
n=5 Participants
|
|
Prior Treatment
No prior treatment
|
5 Participants
n=5 Participants
|
|
Clinical Global Impression-Severity Score
|
5.14 units on a scale
STANDARD_DEVIATION 0.69 • n=5 Participants
|
|
Children's Global Assessment Scale
|
49.9 units on a scale
STANDARD_DEVIATION 2.04 • n=5 Participants
|
PRIMARY outcome
Timeframe: 8 weeksChange from baseline to endpoint of investigator-scored, parent version of the Attention Deficit Hyperactivity Disorder Rating Scale-IV (ADHD-IV rating scale). The ADHD-IV contains 18 items, and each item is rated 0, 1, 2 or 3. Minimum score is 0. Maximum score is 54. Change in score represents the difference between the total score at end point compared to the total score at baseline. Higher scores indicate greater symptom severity.
Outcome measures
| Measure |
Group 1
n=7 Participants
All subjects treated with open-label methylphenidate (Ritalin LA)
|
|---|---|
|
Change in Attention Deficit Hyperactivity Disorder Rating Scale-IV Parent Version Investigator-Scored (ADHD-IV-Parent: Inv) Total Score.
|
-20.1 units on a scale
Standard Deviation 13.87
|
SECONDARY outcome
Timeframe: 8 weeksChange in global rating of severity of ADHD symptoms. CGI severity is rated on a scale of 1 to 6 (normal to severely ill; refer to description in baseline information). The change in the severity rating reflects the change in this score from baseline to endpoint. The greater the reduction in score the more improvement has been observed.
Outcome measures
| Measure |
Group 1
n=7 Participants
All subjects treated with open-label methylphenidate (Ritalin LA)
|
|---|---|
|
Change in Clinical Global Impression-Severity
|
-2.4 units on a scale
Standard Deviation 1.72
|
SECONDARY outcome
Timeframe: 8 weeksThis measures the change in the subject's global assessment of functioning as rated by the clinician. This Children's Global Assessment Scale (CGAS) is rated on a 0-100 scale (refer to baseline information). The change in this score is the difference between the score at baseline to end point. The greater the change score, the more improvement has been observed.
Outcome measures
| Measure |
Group 1
n=7 Participants
All subjects treated with open-label methylphenidate (Ritalin LA)
|
|---|---|
|
Change in Children's Global Assessment Scale (CGAS) Score
|
9.9 units on a scale
Standard Deviation 6.07
|
SECONDARY outcome
Timeframe: 8 weeksThe Clinical Global Impression-Improvement scale is a measure of the clinician's assessment of the overall degree of improvement in ADHD symptoms from baseline to endpoint. The CGI-I is rated on a 1 to 6 scale, with 1=very much improved, 2=much improved, 3=minimally improved, 4= no change, 5= minimally worse, 6=much worse. Low numerical score on this scale indicates greater improvement.
Outcome measures
| Measure |
Group 1
n=7 Participants
All subjects treated with open-label methylphenidate (Ritalin LA)
|
|---|---|
|
Clinical Global Impression- Improvement
Much Worse
|
0 Participants
|
|
Clinical Global Impression- Improvement
Very Much Improved
|
3 Participants
|
|
Clinical Global Impression- Improvement
Much Improved
|
2 Participants
|
|
Clinical Global Impression- Improvement
Minimally Improved
|
1 Participants
|
|
Clinical Global Impression- Improvement
No Change
|
1 Participants
|
|
Clinical Global Impression- Improvement
Minimally Worse
|
0 Participants
|
Adverse Events
Methylpehnidate
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Methylpehnidate
n=7 participants at risk
open-label treatment with methylphenidate
methylphenidate: Starting dose: methylphenidate (immediate-release pill) or Methylin (immediate-release chewable tablet for those unable to swallow pills) 2.5mg Q AM and Q noon. Target dose of 1mg/kg/day. Titration will occur as follows: 5mg Q AM and Q noon, then 7.5mg Q AM and Q noon, then 10mg Q AM and Q noon, as tolerated, not to exceed 30mg per day. Once each child arrives at a stable dose with a good response and good tolerability, they will be converted to the closest Ritalin LA dose, with a target dose of 1mg/kg/day.
|
|---|---|
|
Gastrointestinal disorders
Decreased Appetite
|
42.9%
3/7 • Number of events 3 • 8 weeks
Adverse events were collected by spontaneous report
|
|
General disorders
Irritability
|
28.6%
2/7 • Number of events 2 • 8 weeks
Adverse events were collected by spontaneous report
|
|
Gastrointestinal disorders
Nausea
|
14.3%
1/7 • Number of events 1 • 8 weeks
Adverse events were collected by spontaneous report
|
|
General disorders
Nail biting
|
14.3%
1/7 • Number of events 1 • 8 weeks
Adverse events were collected by spontaneous report
|
|
Nervous system disorders
Tics
|
14.3%
1/7 • Number of events 2 • 8 weeks
Adverse events were collected by spontaneous report
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place