Trial Outcomes & Findings for The Effects of ADHD Medication (TEAM) Study (NCT NCT02293655)
NCT ID: NCT02293655
Last Updated: 2023-12-21
Results Overview
Parent Vanderbilt ADHD Rating Scale Total Symptom Score, minimum=0, maximum=54, higher scores indicate more/worse ADHD symptoms
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
204 participants
Primary outcome timeframe
baseline, study weeks 8, 9, 10, 12
Results posted on
2023-12-21
Participant Flow
The number Enrolled (those who signed informed consent) differs from the number who Started in the Participant Flow module because: 1) some children who signed informed consent were determined to be ineligible after having formal assessment for study inclusion, 2) some children were unable to learn to swallow the study pill so could not start protocol participation, 3) some families changed their minds about participating after signing informed consent but before starting study procedures.
Participant milestones
| Measure |
MPH Discontinuation
1. Double-blind (DB) placebo-controlled 4-week methylphenidate (MPH) titration trial. Pts will receive 3 active dosages of MPH (children \<25kg: 18mg, 27mg, 36mg; children \>25kg: 18mg, 36mg, 54mg for) as well as 1 random week of placebo, given qAM. Pts will begin on the lowest dose (or a randomized placebo week) and proceed through all dose conditions in an incremental fashion.
2. DB 4-week MPH maintenance phase. The clinician, parent, and teacher ratings of behavior and side effects from the titration trial weeks will be graphed. Two doctors will blindly review the graphs and judge which week was the optimal dose week. Pts will then receive their optimal dose of MPH (qAM) for 4 weeks.
3. DB 4-week MPH Discontinuation Phase. Pts in this arm will receive placebo (qAM).
OROS-Methylphenidate (MPH): OROS-methylphenidate will be taken orally once daily at doses that have been approved for the study age group by the U.S. FDA.
|
Sustained MPH
1. Double-blind (DB) placebo-controlled 4-week methylphenidate (MPH) titration trial. Pts will receive 3 active dosages of MPH (children \<25kg: 18mg, 27mg, 36mg; children \>25kg: 18mg, 36mg, 54mg for) as well as 1 random week of placebo, given qAM. Pts will begin on the lowest dose (or a randomized placebo week) and proceed through all dose conditions in an incremental fashion.
2. DB 4-week MPH maintenance phase. The clinician, parent, and teacher ratings of behavior and side effects from the titration trial weeks will be graphed. Two doctors will blindly review the graphs and judge which week was the optimal dose week. Pts will then receive their optimal dose of MPH (qAM) for 4 weeks.
3. DB 4-week MPH Discontinuation Phase. Pts in this arm will continue their optimal MPH dose (qAM).
OROS-Methylphenidate (MPH): OROS-methylphenidate will be taken orally once daily at doses that have been approved for the study age group by the U.S. FDA.
|
|---|---|---|
|
Overall Study
STARTED
|
92
|
17
|
|
Overall Study
COMPLETED
|
85
|
15
|
|
Overall Study
NOT COMPLETED
|
7
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Effects of ADHD Medication (TEAM) Study
Baseline characteristics by cohort
| Measure |
MPH Discontinuation
n=92 Participants
1. Double-blind (DB) placebo-controlled 4-week methylphenidate (MPH) titration trial. Pts will receive 3 active dosages of MPH (children \<25kg: 18mg, 27mg, 36mg; children \>25kg: 18mg, 36mg, 54mg for) as well as 1 random week of placebo, given qAM. Pts will begin on the lowest dose (or a randomized placebo week) and proceed through all dose conditions in an incremental fashion.
2. DB 4-week MPH maintenance phase. The clinician, parent, and teacher ratings of behavior and side effects from the titration trial weeks will be graphed. Two doctors will blindly review the graphs and judge which week was the optimal dose week. Pts will then receive their optimal dose of MPH (qAM) for 4 weeks.
3. DB 4-week MPH Discontinuation Phase. Pts in this arm will receive placebo (qAM).
OROS-Methylphenidate (MPH): OROS-methylphenidate will be taken orally once daily at doses that have been approved for the study age group by the U.S. FDA.
|
Sustained MPH
n=17 Participants
1. Double-blind (DB) placebo-controlled 4-week methylphenidate (MPH) titration trial. Pts will receive 3 active dosages of MPH (children \<25kg: 18mg, 27mg, 36mg; children \>25kg: 18mg, 36mg, 54mg for) as well as 1 random week of placebo, given qAM. Pts will begin on the lowest dose (or a randomized placebo week) and proceed through all dose conditions in an incremental fashion.
2. DB 4-week MPH maintenance phase. The clinician, parent, and teacher ratings of behavior and side effects from the titration trial weeks will be graphed. Two doctors will blindly review the graphs and judge which week was the optimal dose week. Pts will then receive their optimal dose of MPH (qAM) for 4 weeks.
3. DB 4-week MPH Discontinuation Phase. Pts in this arm will continue their optimal MPH dose (qAM).
OROS-Methylphenidate (MPH): OROS-methylphenidate will be taken orally once daily at doses that have been approved for the study age group by the U.S. FDA.
|
Total
n=109 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
92 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
109 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
61 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
84 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
73 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
88 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
10 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
92 participants
n=5 Participants
|
17 participants
n=7 Participants
|
109 participants
n=5 Participants
|
|
Parent Vanderbilt ADHD Total Symptom Score
|
36.2 score on a scale
STANDARD_DEVIATION 8.3 • n=5 Participants
|
34.6 score on a scale
STANDARD_DEVIATION 10.9 • n=7 Participants
|
36.0 score on a scale
STANDARD_DEVIATION 8.7 • n=5 Participants
|
PRIMARY outcome
Timeframe: baseline, study weeks 8, 9, 10, 12Population: There was some attrition and missing data at different data collection points.
Parent Vanderbilt ADHD Rating Scale Total Symptom Score, minimum=0, maximum=54, higher scores indicate more/worse ADHD symptoms
Outcome measures
| Measure |
MPH Discontinuation
n=92 Participants
1. Double-blind (DB) placebo-controlled 4-week methylphenidate (MPH) titration trial. Pts will receive 3 active dosages of MPH (children \<25kg: 18mg, 27mg, 36mg; children \>25kg: 18mg, 36mg, 54mg for) as well as 1 random week of placebo, given qAM. Pts will begin on the lowest dose (or a randomized placebo week) and proceed through all dose conditions in an incremental fashion.
2. DB 4-week MPH maintenance phase. The clinician, parent, and teacher ratings of behavior and side effects from the titration trial weeks will be graphed. Two doctors will blindly review the graphs and judge which week was the optimal dose week. Pts will then receive their optimal dose of MPH (qAM) for 4 weeks.
3. DB 4-week MPH Discontinuation Phase. Pts in this arm will receive placebo (qAM).
OROS-Methylphenidate (MPH): OROS-methylphenidate will be taken orally once daily at doses that have been approved for the study age group by the U.S. FDA.
|
Sustained MPH
n=17 Participants
1. Double-blind (DB) placebo-controlled 4-week methylphenidate (MPH) titration trial. Pts will receive 3 active dosages of MPH (children \<25kg: 18mg, 27mg, 36mg; children \>25kg: 18mg, 36mg, 54mg for) as well as 1 random week of placebo, given qAM. Pts will begin on the lowest dose (or a randomized placebo week) and proceed through all dose conditions in an incremental fashion.
2. DB 4-week MPH maintenance phase. The clinician, parent, and teacher ratings of behavior and side effects from the titration trial weeks will be graphed. Two doctors will blindly review the graphs and judge which week was the optimal dose week. Pts will then receive their optimal dose of MPH (qAM) for 4 weeks.
3. DB 4-week MPH Discontinuation Phase. Pts in this arm will continue their optimal MPH dose (qAM).
OROS-Methylphenidate (MPH): OROS-methylphenidate will be taken orally once daily at doses that have been approved for the study age group by the U.S. FDA.
|
|---|---|---|
|
Parent ADHD Total Symptom Scores
Baseline
|
36.2 score on a scale
Standard Deviation 8.3
|
34.6 score on a scale
Standard Deviation 10.9
|
|
Parent ADHD Total Symptom Scores
Maintenance Visit (week 8)
|
17.6 score on a scale
Standard Deviation 8.8
|
15.3 score on a scale
Standard Deviation 8.3
|
|
Parent ADHD Total Symptom Scores
Randomization 1 (week 9)
|
16.5 score on a scale
Standard Deviation 12.0
|
12.3 score on a scale
Standard Deviation 10.4
|
|
Parent ADHD Total Symptom Scores
Randomization 2 (week 10)
|
23.8 score on a scale
Standard Deviation 11.6
|
14.3 score on a scale
Standard Deviation 8.3
|
|
Parent ADHD Total Symptom Scores
Randomization 3 (week 12)
|
25.2 score on a scale
Standard Deviation 11.6
|
17.3 score on a scale
Standard Deviation 12.3
|
PRIMARY outcome
Timeframe: baseline, study weeks 8, 9, 10 & 12Population: There was some attrition and missing data at different data collection points.
Assessed via the Go/No-Go computerized measure of inhibitory control reaction time variability (with standard deviation of the reaction time being the indicator variability variability). Unit of measure is msec. Minimum is 0, Maximum is 500. Higher scores indicate more variability (higher standard deviation) in reaction time, indicating worse outcome (more characteristic of individuals with ADHD and less characteristic of typically developing individuals).
Outcome measures
| Measure |
MPH Discontinuation
n=85 Participants
1. Double-blind (DB) placebo-controlled 4-week methylphenidate (MPH) titration trial. Pts will receive 3 active dosages of MPH (children \<25kg: 18mg, 27mg, 36mg; children \>25kg: 18mg, 36mg, 54mg for) as well as 1 random week of placebo, given qAM. Pts will begin on the lowest dose (or a randomized placebo week) and proceed through all dose conditions in an incremental fashion.
2. DB 4-week MPH maintenance phase. The clinician, parent, and teacher ratings of behavior and side effects from the titration trial weeks will be graphed. Two doctors will blindly review the graphs and judge which week was the optimal dose week. Pts will then receive their optimal dose of MPH (qAM) for 4 weeks.
3. DB 4-week MPH Discontinuation Phase. Pts in this arm will receive placebo (qAM).
OROS-Methylphenidate (MPH): OROS-methylphenidate will be taken orally once daily at doses that have been approved for the study age group by the U.S. FDA.
|
Sustained MPH
n=14 Participants
1. Double-blind (DB) placebo-controlled 4-week methylphenidate (MPH) titration trial. Pts will receive 3 active dosages of MPH (children \<25kg: 18mg, 27mg, 36mg; children \>25kg: 18mg, 36mg, 54mg for) as well as 1 random week of placebo, given qAM. Pts will begin on the lowest dose (or a randomized placebo week) and proceed through all dose conditions in an incremental fashion.
2. DB 4-week MPH maintenance phase. The clinician, parent, and teacher ratings of behavior and side effects from the titration trial weeks will be graphed. Two doctors will blindly review the graphs and judge which week was the optimal dose week. Pts will then receive their optimal dose of MPH (qAM) for 4 weeks.
3. DB 4-week MPH Discontinuation Phase. Pts in this arm will continue their optimal MPH dose (qAM).
OROS-Methylphenidate (MPH): OROS-methylphenidate will be taken orally once daily at doses that have been approved for the study age group by the U.S. FDA.
|
|---|---|---|
|
Inhibitory Control Reaction Time Variability (SD of the Reaction Time)
Baseline
|
219.6 msec
Standard Error 17.8
|
196.0 msec
Standard Error 27.9
|
|
Inhibitory Control Reaction Time Variability (SD of the Reaction Time)
Maintenance Visit (week 8)
|
195.9 msec
Standard Error 17.1
|
199.6 msec
Standard Error 31.5
|
|
Inhibitory Control Reaction Time Variability (SD of the Reaction Time)
Randomization 1 (week 9)
|
250.8 msec
Standard Error 18.8
|
183.8 msec
Standard Error 37.1
|
|
Inhibitory Control Reaction Time Variability (SD of the Reaction Time)
Randomization 2 (week 10)
|
288.2 msec
Standard Error 19.3
|
228.5 msec
Standard Error 52.8
|
|
Inhibitory Control Reaction Time Variability (SD of the Reaction Time)
Randomization 3 (week 12)
|
285.2 msec
Standard Error 20.3
|
199.8 msec
Standard Error 36.0
|
PRIMARY outcome
Timeframe: baseline, study weeks 8, 9, 10 & 12Population: There was some attrition and missing data at different data collection points.
Math Computation Curriculum-Based Measure - Number of Problems Completed Correctly. Minimum=0, Maximum=600. Higher scores indicate improved/better performance
Outcome measures
| Measure |
MPH Discontinuation
n=91 Participants
1. Double-blind (DB) placebo-controlled 4-week methylphenidate (MPH) titration trial. Pts will receive 3 active dosages of MPH (children \<25kg: 18mg, 27mg, 36mg; children \>25kg: 18mg, 36mg, 54mg for) as well as 1 random week of placebo, given qAM. Pts will begin on the lowest dose (or a randomized placebo week) and proceed through all dose conditions in an incremental fashion.
2. DB 4-week MPH maintenance phase. The clinician, parent, and teacher ratings of behavior and side effects from the titration trial weeks will be graphed. Two doctors will blindly review the graphs and judge which week was the optimal dose week. Pts will then receive their optimal dose of MPH (qAM) for 4 weeks.
3. DB 4-week MPH Discontinuation Phase. Pts in this arm will receive placebo (qAM).
OROS-Methylphenidate (MPH): OROS-methylphenidate will be taken orally once daily at doses that have been approved for the study age group by the U.S. FDA.
|
Sustained MPH
n=17 Participants
1. Double-blind (DB) placebo-controlled 4-week methylphenidate (MPH) titration trial. Pts will receive 3 active dosages of MPH (children \<25kg: 18mg, 27mg, 36mg; children \>25kg: 18mg, 36mg, 54mg for) as well as 1 random week of placebo, given qAM. Pts will begin on the lowest dose (or a randomized placebo week) and proceed through all dose conditions in an incremental fashion.
2. DB 4-week MPH maintenance phase. The clinician, parent, and teacher ratings of behavior and side effects from the titration trial weeks will be graphed. Two doctors will blindly review the graphs and judge which week was the optimal dose week. Pts will then receive their optimal dose of MPH (qAM) for 4 weeks.
3. DB 4-week MPH Discontinuation Phase. Pts in this arm will continue their optimal MPH dose (qAM).
OROS-Methylphenidate (MPH): OROS-methylphenidate will be taken orally once daily at doses that have been approved for the study age group by the U.S. FDA.
|
|---|---|---|
|
Math Computation - Number of Problems Completed Correctly
Baseline
|
200.84 Number of problems completed correctly
Standard Deviation 152.8
|
230.93 Number of problems completed correctly
Standard Deviation 127.3
|
|
Math Computation - Number of Problems Completed Correctly
Maintenance Visit (week 8)
|
264.71 Number of problems completed correctly
Standard Deviation 157.4
|
320.12 Number of problems completed correctly
Standard Deviation 142.3
|
|
Math Computation - Number of Problems Completed Correctly
Randomization 1 (week 9)
|
221.19 Number of problems completed correctly
Standard Deviation 175.3
|
333.50 Number of problems completed correctly
Standard Deviation 214.1
|
|
Math Computation - Number of Problems Completed Correctly
Randomization 2 (week 10)
|
201.69 Number of problems completed correctly
Standard Deviation 164.3
|
323.25 Number of problems completed correctly
Standard Deviation 203.6
|
|
Math Computation - Number of Problems Completed Correctly
Randomization 3 (week 12)
|
201.10 Number of problems completed correctly
Standard Deviation 180.3
|
277.51 Number of problems completed correctly
Standard Deviation 190.0
|
PRIMARY outcome
Timeframe: baseline, study weeks 8, 9, 10, 12Population: There was some attrition and missing data at different data collection points.
Participants were videotaped while completing the 20-minute Analogue Math task. Their behavior was coded in 20-second intervals by trained coders who determined if the children were on-task or off-task during each interval. The amount of time coded as on-task was divided by the total amount of time and then multiplied by 100 to generate the % of time on task variable.
Outcome measures
| Measure |
MPH Discontinuation
n=81 Participants
1. Double-blind (DB) placebo-controlled 4-week methylphenidate (MPH) titration trial. Pts will receive 3 active dosages of MPH (children \<25kg: 18mg, 27mg, 36mg; children \>25kg: 18mg, 36mg, 54mg for) as well as 1 random week of placebo, given qAM. Pts will begin on the lowest dose (or a randomized placebo week) and proceed through all dose conditions in an incremental fashion.
2. DB 4-week MPH maintenance phase. The clinician, parent, and teacher ratings of behavior and side effects from the titration trial weeks will be graphed. Two doctors will blindly review the graphs and judge which week was the optimal dose week. Pts will then receive their optimal dose of MPH (qAM) for 4 weeks.
3. DB 4-week MPH Discontinuation Phase. Pts in this arm will receive placebo (qAM).
OROS-Methylphenidate (MPH): OROS-methylphenidate will be taken orally once daily at doses that have been approved for the study age group by the U.S. FDA.
|
Sustained MPH
n=15 Participants
1. Double-blind (DB) placebo-controlled 4-week methylphenidate (MPH) titration trial. Pts will receive 3 active dosages of MPH (children \<25kg: 18mg, 27mg, 36mg; children \>25kg: 18mg, 36mg, 54mg for) as well as 1 random week of placebo, given qAM. Pts will begin on the lowest dose (or a randomized placebo week) and proceed through all dose conditions in an incremental fashion.
2. DB 4-week MPH maintenance phase. The clinician, parent, and teacher ratings of behavior and side effects from the titration trial weeks will be graphed. Two doctors will blindly review the graphs and judge which week was the optimal dose week. Pts will then receive their optimal dose of MPH (qAM) for 4 weeks.
3. DB 4-week MPH Discontinuation Phase. Pts in this arm will continue their optimal MPH dose (qAM).
OROS-Methylphenidate (MPH): OROS-methylphenidate will be taken orally once daily at doses that have been approved for the study age group by the U.S. FDA.
|
|---|---|---|
|
% Time on Task
Baseline
|
74.4 percentage of time spent on task
Standard Error 4.2
|
85.2 percentage of time spent on task
Standard Error 6.4
|
|
% Time on Task
Week 8 (MPH Maintenance dose)
|
83.9 percentage of time spent on task
Standard Error 3.8
|
92.7 percentage of time spent on task
Standard Error 3.9
|
|
% Time on Task
Week 9
|
73.1 percentage of time spent on task
Standard Error 3.6
|
91.5 percentage of time spent on task
Standard Error 4.3
|
|
% Time on Task
Week 10
|
69.5 percentage of time spent on task
Standard Error 4.2
|
89.2 percentage of time spent on task
Standard Error 4.2
|
|
% Time on Task
Week 12
|
66.6 percentage of time spent on task
Standard Error 4.5
|
82.6 percentage of time spent on task
Standard Error 6.5
|
SECONDARY outcome
Timeframe: baseline, study weeks 8, 9, 10 &12Population: Note: There was some missing data as well as attrition. the numbers of participants with available data for this outcome has been verified.
assessed via parent-completed Barkley Sluggish Cognitive Tempo Scale. Minimum=12, Max=48, higher scores indicate worse outcome.
Outcome measures
| Measure |
MPH Discontinuation
n=71 Participants
1. Double-blind (DB) placebo-controlled 4-week methylphenidate (MPH) titration trial. Pts will receive 3 active dosages of MPH (children \<25kg: 18mg, 27mg, 36mg; children \>25kg: 18mg, 36mg, 54mg for) as well as 1 random week of placebo, given qAM. Pts will begin on the lowest dose (or a randomized placebo week) and proceed through all dose conditions in an incremental fashion.
2. DB 4-week MPH maintenance phase. The clinician, parent, and teacher ratings of behavior and side effects from the titration trial weeks will be graphed. Two doctors will blindly review the graphs and judge which week was the optimal dose week. Pts will then receive their optimal dose of MPH (qAM) for 4 weeks.
3. DB 4-week MPH Discontinuation Phase. Pts in this arm will receive placebo (qAM).
OROS-Methylphenidate (MPH): OROS-methylphenidate will be taken orally once daily at doses that have been approved for the study age group by the U.S. FDA.
|
Sustained MPH
n=17 Participants
1. Double-blind (DB) placebo-controlled 4-week methylphenidate (MPH) titration trial. Pts will receive 3 active dosages of MPH (children \<25kg: 18mg, 27mg, 36mg; children \>25kg: 18mg, 36mg, 54mg for) as well as 1 random week of placebo, given qAM. Pts will begin on the lowest dose (or a randomized placebo week) and proceed through all dose conditions in an incremental fashion.
2. DB 4-week MPH maintenance phase. The clinician, parent, and teacher ratings of behavior and side effects from the titration trial weeks will be graphed. Two doctors will blindly review the graphs and judge which week was the optimal dose week. Pts will then receive their optimal dose of MPH (qAM) for 4 weeks.
3. DB 4-week MPH Discontinuation Phase. Pts in this arm will continue their optimal MPH dose (qAM).
OROS-Methylphenidate (MPH): OROS-methylphenidate will be taken orally once daily at doses that have been approved for the study age group by the U.S. FDA.
|
|---|---|---|
|
Barkley Sluggish Cognitive Tempo (SCT) Ratings
Baseline (week 1)
|
24.41 score on a scale
Standard Error 1.26
|
24.19 score on a scale
Standard Error 1.33
|
|
Barkley Sluggish Cognitive Tempo (SCT) Ratings
Maintenance (week 8)
|
18.5 score on a scale
Standard Error 1.1
|
18.2 score on a scale
Standard Error 1.0
|
|
Barkley Sluggish Cognitive Tempo (SCT) Ratings
Randomization 1 (week 9)
|
18.4 score on a scale
Standard Error 1.2
|
17.5 score on a scale
Standard Error 1.3
|
|
Barkley Sluggish Cognitive Tempo (SCT) Ratings
Randomization 2 (week 10)
|
18.7 score on a scale
Standard Error 1.1
|
18.0 score on a scale
Standard Error 1.1
|
|
Barkley Sluggish Cognitive Tempo (SCT) Ratings
Randomization 3 (week 12)
|
18.8 score on a scale
Standard Error 1.1
|
17.6 score on a scale
Standard Error 1.0
|
SECONDARY outcome
Timeframe: baseline, study weeks 8, 9, 10 &12Population: There was some attrition and some missing data. # of participants with available data has been verified.
assessed via parent-completed Emotion Regulation Checklist (ERC). Outcome assessed is ERC total mean score: minimum value=1, max value=4, higher scores indicate worse outcome
Outcome measures
| Measure |
MPH Discontinuation
n=71 Participants
1. Double-blind (DB) placebo-controlled 4-week methylphenidate (MPH) titration trial. Pts will receive 3 active dosages of MPH (children \<25kg: 18mg, 27mg, 36mg; children \>25kg: 18mg, 36mg, 54mg for) as well as 1 random week of placebo, given qAM. Pts will begin on the lowest dose (or a randomized placebo week) and proceed through all dose conditions in an incremental fashion.
2. DB 4-week MPH maintenance phase. The clinician, parent, and teacher ratings of behavior and side effects from the titration trial weeks will be graphed. Two doctors will blindly review the graphs and judge which week was the optimal dose week. Pts will then receive their optimal dose of MPH (qAM) for 4 weeks.
3. DB 4-week MPH Discontinuation Phase. Pts in this arm will receive placebo (qAM).
OROS-Methylphenidate (MPH): OROS-methylphenidate will be taken orally once daily at doses that have been approved for the study age group by the U.S. FDA.
|
Sustained MPH
n=14 Participants
1. Double-blind (DB) placebo-controlled 4-week methylphenidate (MPH) titration trial. Pts will receive 3 active dosages of MPH (children \<25kg: 18mg, 27mg, 36mg; children \>25kg: 18mg, 36mg, 54mg for) as well as 1 random week of placebo, given qAM. Pts will begin on the lowest dose (or a randomized placebo week) and proceed through all dose conditions in an incremental fashion.
2. DB 4-week MPH maintenance phase. The clinician, parent, and teacher ratings of behavior and side effects from the titration trial weeks will be graphed. Two doctors will blindly review the graphs and judge which week was the optimal dose week. Pts will then receive their optimal dose of MPH (qAM) for 4 weeks.
3. DB 4-week MPH Discontinuation Phase. Pts in this arm will continue their optimal MPH dose (qAM).
OROS-Methylphenidate (MPH): OROS-methylphenidate will be taken orally once daily at doses that have been approved for the study age group by the U.S. FDA.
|
|---|---|---|
|
Parent Ratings of Emotional Regulation
Randomization 2 (wk 10)
|
1.9 score on a scale
Standard Error 0.1
|
1.8 score on a scale
Standard Error 0.1
|
|
Parent Ratings of Emotional Regulation
Randomization 3 (wk 12)
|
1.9 score on a scale
Standard Error 0.1
|
1.8 score on a scale
Standard Error 0.1
|
|
Parent Ratings of Emotional Regulation
Baseline
|
2.1 score on a scale
Standard Error 0.1
|
2.1 score on a scale
Standard Error 0.2
|
|
Parent Ratings of Emotional Regulation
Maintenance (wk 8)
|
1.8 score on a scale
Standard Error 0.1
|
1.8 score on a scale
Standard Error 0.1
|
|
Parent Ratings of Emotional Regulation
Randomization 1 (wk 9)
|
1.8 score on a scale
Standard Error 0.2
|
1.7 score on a scale
Standard Error 0.1
|
SECONDARY outcome
Timeframe: baseline, study weeks 8, 9, 10 &12Population: some missing data due to attrition, non-valid trials/responses, and equipment failure. # of participants with available data has been verified.
Spatial working memory was assessed via the Corsi Computerized Spatial Span Task, which requires the participant to reproduce a sequence of movements by tapping a series of blocks on a computer screen in the same order demonstrated by the examiner. Outcome of interest is total trials correct. Minimum score=0, max score=10. Higher scores indicate better performance.
Outcome measures
| Measure |
MPH Discontinuation
n=82 Participants
1. Double-blind (DB) placebo-controlled 4-week methylphenidate (MPH) titration trial. Pts will receive 3 active dosages of MPH (children \<25kg: 18mg, 27mg, 36mg; children \>25kg: 18mg, 36mg, 54mg for) as well as 1 random week of placebo, given qAM. Pts will begin on the lowest dose (or a randomized placebo week) and proceed through all dose conditions in an incremental fashion.
2. DB 4-week MPH maintenance phase. The clinician, parent, and teacher ratings of behavior and side effects from the titration trial weeks will be graphed. Two doctors will blindly review the graphs and judge which week was the optimal dose week. Pts will then receive their optimal dose of MPH (qAM) for 4 weeks.
3. DB 4-week MPH Discontinuation Phase. Pts in this arm will receive placebo (qAM).
OROS-Methylphenidate (MPH): OROS-methylphenidate will be taken orally once daily at doses that have been approved for the study age group by the U.S. FDA.
|
Sustained MPH
n=16 Participants
1. Double-blind (DB) placebo-controlled 4-week methylphenidate (MPH) titration trial. Pts will receive 3 active dosages of MPH (children \<25kg: 18mg, 27mg, 36mg; children \>25kg: 18mg, 36mg, 54mg for) as well as 1 random week of placebo, given qAM. Pts will begin on the lowest dose (or a randomized placebo week) and proceed through all dose conditions in an incremental fashion.
2. DB 4-week MPH maintenance phase. The clinician, parent, and teacher ratings of behavior and side effects from the titration trial weeks will be graphed. Two doctors will blindly review the graphs and judge which week was the optimal dose week. Pts will then receive their optimal dose of MPH (qAM) for 4 weeks.
3. DB 4-week MPH Discontinuation Phase. Pts in this arm will continue their optimal MPH dose (qAM).
OROS-Methylphenidate (MPH): OROS-methylphenidate will be taken orally once daily at doses that have been approved for the study age group by the U.S. FDA.
|
|---|---|---|
|
Spatial Working Memory
Baseline
|
6.43 total number of correct trials
Standard Error .27
|
6.83 total number of correct trials
Standard Error .33
|
|
Spatial Working Memory
Week 8 (med maintenance)
|
6.46 total number of correct trials
Standard Error .25
|
6.63 total number of correct trials
Standard Error .40
|
|
Spatial Working Memory
week 9
|
6.67 total number of correct trials
Standard Error .25
|
7.42 total number of correct trials
Standard Error .42
|
|
Spatial Working Memory
week 10
|
6.54 total number of correct trials
Standard Error .28
|
7.61 total number of correct trials
Standard Error .39
|
|
Spatial Working Memory
week 12
|
6.48 total number of correct trials
Standard Error .29
|
7.24 total number of correct trials
Standard Error .45
|
SECONDARY outcome
Timeframe: baseline, study weeks 1, 8, 9, 10 &12Population: some missing data due to factors such as attrition and the test not being appropriate to administer all grade levels (e.g., not designed for participants who were in 1st grade) grade. # of participants with available data has been verified.
Math reasoning was assessed by child completion of the AIMSWEB curriculum based measure (CBM) test of Math Concepts and Applications. At baseline (week 1), child's performance was assigned a value of 1.0. The child's performance at weeks 8, 9, 10, and 12 was derived by dividing actual score on the test by the score predicted at that time point after applying the measure's normed "rate of improvement (ROI)" metric to the baseline score. For example, a score of 1.5 at week 8 would indicate that the child's actual score at week 8 was 50% higher than the predicted score at week 8 (which was derived by applying the normed ROI metric to the baseline score). Scores at weeks 8, 9, 10, 12 that are \>1.0 indicate greater improvement than expected (so better outcome), while scores at weeks 8, 9, 10, 12 that are \<1.0 indicate less improvement than expected (so worse outcome).
Outcome measures
| Measure |
MPH Discontinuation
n=82 Participants
1. Double-blind (DB) placebo-controlled 4-week methylphenidate (MPH) titration trial. Pts will receive 3 active dosages of MPH (children \<25kg: 18mg, 27mg, 36mg; children \>25kg: 18mg, 36mg, 54mg for) as well as 1 random week of placebo, given qAM. Pts will begin on the lowest dose (or a randomized placebo week) and proceed through all dose conditions in an incremental fashion.
2. DB 4-week MPH maintenance phase. The clinician, parent, and teacher ratings of behavior and side effects from the titration trial weeks will be graphed. Two doctors will blindly review the graphs and judge which week was the optimal dose week. Pts will then receive their optimal dose of MPH (qAM) for 4 weeks.
3. DB 4-week MPH Discontinuation Phase. Pts in this arm will receive placebo (qAM).
OROS-Methylphenidate (MPH): OROS-methylphenidate will be taken orally once daily at doses that have been approved for the study age group by the U.S. FDA.
|
Sustained MPH
n=14 Participants
1. Double-blind (DB) placebo-controlled 4-week methylphenidate (MPH) titration trial. Pts will receive 3 active dosages of MPH (children \<25kg: 18mg, 27mg, 36mg; children \>25kg: 18mg, 36mg, 54mg for) as well as 1 random week of placebo, given qAM. Pts will begin on the lowest dose (or a randomized placebo week) and proceed through all dose conditions in an incremental fashion.
2. DB 4-week MPH maintenance phase. The clinician, parent, and teacher ratings of behavior and side effects from the titration trial weeks will be graphed. Two doctors will blindly review the graphs and judge which week was the optimal dose week. Pts will then receive their optimal dose of MPH (qAM) for 4 weeks.
3. DB 4-week MPH Discontinuation Phase. Pts in this arm will continue their optimal MPH dose (qAM).
OROS-Methylphenidate (MPH): OROS-methylphenidate will be taken orally once daily at doses that have been approved for the study age group by the U.S. FDA.
|
|---|---|---|
|
Math Reasoning
Baseline
|
1.0 percentage of expected improvement
Standard Error 0.0
|
1.0 percentage of expected improvement
Standard Error 0.0
|
|
Math Reasoning
Week 8
|
1.09 percentage of expected improvement
Standard Error 0.06
|
1.27 percentage of expected improvement
Standard Error 0.08
|
|
Math Reasoning
week 9
|
1.11 percentage of expected improvement
Standard Error 0.62
|
1.50 percentage of expected improvement
Standard Error 0.15
|
|
Math Reasoning
week 10
|
1.15 percentage of expected improvement
Standard Error 0.07
|
1.50 percentage of expected improvement
Standard Error 0.13
|
|
Math Reasoning
week 12
|
1.10 percentage of expected improvement
Standard Error 0.06
|
1.65 percentage of expected improvement
Standard Error 0.16
|
SECONDARY outcome
Timeframe: baseline, study weeks 8, 9, 10 &12Population: some missing data due to attrition, non-valid test administration. Numbers of participants with available data has been verified.
Reading Comprehension was assessed by child completion of the AIMSWEB curriculum based measure (CBM) test of Reading Comprehension. At baseline (week 1), child's performance was assigned a value of 1.0. The child's performance at weeks 8, 9, 10, and 12 was derived by dividing actual score on the test by the score predicted at that time point after applying the measure's normed "rate of improvement (ROI)" metric to the baseline score. For example, a score of 1.5 at week 8 would indicate that the child's actual score at week 8 was 50% higher than the predicted score at week 8 (which was derived by applying the normed ROI metric to the baseline score). Scores at weeks 8, 9, 10, 12 that are \>1.0 indicate greater improvement than expected (so better outcome), while scores at weeks 8, 9, 10, 12 that are \<1.0 indicate less improvement than expected (so worse outcome).
Outcome measures
| Measure |
MPH Discontinuation
n=84 Participants
1. Double-blind (DB) placebo-controlled 4-week methylphenidate (MPH) titration trial. Pts will receive 3 active dosages of MPH (children \<25kg: 18mg, 27mg, 36mg; children \>25kg: 18mg, 36mg, 54mg for) as well as 1 random week of placebo, given qAM. Pts will begin on the lowest dose (or a randomized placebo week) and proceed through all dose conditions in an incremental fashion.
2. DB 4-week MPH maintenance phase. The clinician, parent, and teacher ratings of behavior and side effects from the titration trial weeks will be graphed. Two doctors will blindly review the graphs and judge which week was the optimal dose week. Pts will then receive their optimal dose of MPH (qAM) for 4 weeks.
3. DB 4-week MPH Discontinuation Phase. Pts in this arm will receive placebo (qAM).
OROS-Methylphenidate (MPH): OROS-methylphenidate will be taken orally once daily at doses that have been approved for the study age group by the U.S. FDA.
|
Sustained MPH
n=16 Participants
1. Double-blind (DB) placebo-controlled 4-week methylphenidate (MPH) titration trial. Pts will receive 3 active dosages of MPH (children \<25kg: 18mg, 27mg, 36mg; children \>25kg: 18mg, 36mg, 54mg for) as well as 1 random week of placebo, given qAM. Pts will begin on the lowest dose (or a randomized placebo week) and proceed through all dose conditions in an incremental fashion.
2. DB 4-week MPH maintenance phase. The clinician, parent, and teacher ratings of behavior and side effects from the titration trial weeks will be graphed. Two doctors will blindly review the graphs and judge which week was the optimal dose week. Pts will then receive their optimal dose of MPH (qAM) for 4 weeks.
3. DB 4-week MPH Discontinuation Phase. Pts in this arm will continue their optimal MPH dose (qAM).
OROS-Methylphenidate (MPH): OROS-methylphenidate will be taken orally once daily at doses that have been approved for the study age group by the U.S. FDA.
|
|---|---|---|
|
Reading Comprehension
baseline
|
1.00 percentage of expected improvement
Standard Error 0.0
|
1.00 percentage of expected improvement
Standard Error 0.0
|
|
Reading Comprehension
week 8
|
1.00 percentage of expected improvement
Standard Error 0.05
|
0.99 percentage of expected improvement
Standard Error 0.11
|
|
Reading Comprehension
week 9
|
1.02 percentage of expected improvement
Standard Error 0.05
|
1.25 percentage of expected improvement
Standard Error 0.18
|
|
Reading Comprehension
week 10
|
1.12 percentage of expected improvement
Standard Error 0.05
|
1.27 percentage of expected improvement
Standard Error 0.11
|
|
Reading Comprehension
week 12
|
1.01 percentage of expected improvement
Standard Error 0.06
|
1.29 percentage of expected improvement
Standard Error 0.14
|
SECONDARY outcome
Timeframe: baseline, study weeks 1, 8, 9, 10 &12Population: some missing data due to attrition, non-valid responses, etc. # of participants with available data verified.
Assessed by child completion of the AIMSWEB curriculum based measure (CBM) test of Written Expression, with the measure assessing number of words written by the child after receiving a prompt. At baseline (week 1), child's performance was assigned a value of 1.0. The child's performance at weeks 8, 9, 10, and 12 was derived by dividing actual score (# of words written) on the test by the score predicted at that time point after applying the measure's normed "rate of improvement (ROI)" metric to the baseline score. For example, a score of 1.5 at week 8 would indicate that the child's actual score at week 8 was 50% higher than the predicted score at week 8 (which was derived by applying the normed ROI metric to the baseline score). Scores at weeks 8, 9, 10, 12 that are \>1.0 indicate greater improvement than expected (so better outcome), while scores at weeks 8, 9, 10, 12 that are \<1.0 indicate less improvement than expected (so worse outcome).
Outcome measures
| Measure |
MPH Discontinuation
n=81 Participants
1. Double-blind (DB) placebo-controlled 4-week methylphenidate (MPH) titration trial. Pts will receive 3 active dosages of MPH (children \<25kg: 18mg, 27mg, 36mg; children \>25kg: 18mg, 36mg, 54mg for) as well as 1 random week of placebo, given qAM. Pts will begin on the lowest dose (or a randomized placebo week) and proceed through all dose conditions in an incremental fashion.
2. DB 4-week MPH maintenance phase. The clinician, parent, and teacher ratings of behavior and side effects from the titration trial weeks will be graphed. Two doctors will blindly review the graphs and judge which week was the optimal dose week. Pts will then receive their optimal dose of MPH (qAM) for 4 weeks.
3. DB 4-week MPH Discontinuation Phase. Pts in this arm will receive placebo (qAM).
OROS-Methylphenidate (MPH): OROS-methylphenidate will be taken orally once daily at doses that have been approved for the study age group by the U.S. FDA.
|
Sustained MPH
n=17 Participants
1. Double-blind (DB) placebo-controlled 4-week methylphenidate (MPH) titration trial. Pts will receive 3 active dosages of MPH (children \<25kg: 18mg, 27mg, 36mg; children \>25kg: 18mg, 36mg, 54mg for) as well as 1 random week of placebo, given qAM. Pts will begin on the lowest dose (or a randomized placebo week) and proceed through all dose conditions in an incremental fashion.
2. DB 4-week MPH maintenance phase. The clinician, parent, and teacher ratings of behavior and side effects from the titration trial weeks will be graphed. Two doctors will blindly review the graphs and judge which week was the optimal dose week. Pts will then receive their optimal dose of MPH (qAM) for 4 weeks.
3. DB 4-week MPH Discontinuation Phase. Pts in this arm will continue their optimal MPH dose (qAM).
OROS-Methylphenidate (MPH): OROS-methylphenidate will be taken orally once daily at doses that have been approved for the study age group by the U.S. FDA.
|
|---|---|---|
|
Written Expression
baseline
|
1.00 percentage of expected improvement
Standard Error 0.0
|
1.00 percentage of expected improvement
Standard Error 0.0
|
|
Written Expression
week 8
|
1.16 percentage of expected improvement
Standard Error 0.07
|
0.94 percentage of expected improvement
Standard Error 0.08
|
|
Written Expression
week 9
|
1.02 percentage of expected improvement
Standard Error 0.07
|
1.06 percentage of expected improvement
Standard Error 0.09
|
|
Written Expression
week 10
|
1.04 percentage of expected improvement
Standard Error 0.07
|
0.93 percentage of expected improvement
Standard Error 0.08
|
|
Written Expression
week 12
|
0.91 percentage of expected improvement
Standard Error 0.06
|
1.05 percentage of expected improvement
Standard Error 0.10
|
Adverse Events
MPH Discontinuation
Serious events: 1 serious events
Other events: 55 other events
Deaths: 0 deaths
Sustained MPH
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MPH Discontinuation
n=92 participants at risk
1. Double-blind (DB) placebo-controlled 4-week methylphenidate (MPH) titration trial. Pts will receive 3 active dosages of MPH (children \<25kg: 18mg, 27mg, 36mg; children \>25kg: 18mg, 36mg, 54mg for) as well as 1 random week of placebo, given qAM. Pts will begin on the lowest dose (or a randomized placebo week) and proceed through all dose conditions in an incremental fashion.
2. DB 4-week MPH maintenance phase. The clinician, parent, and teacher ratings of behavior and side effects from the titration trial weeks will be graphed. Two doctors will blindly review the graphs and judge which week was the optimal dose week. Pts will then receive their optimal dose of MPH (qAM) for 4 weeks.
3. DB 4-week MPH Discontinuation Phase. Pts in this arm will receive placebo (qAM).
OROS-Methylphenidate (MPH): OROS-methylphenidate will be taken orally once daily at doses that have been approved for the study age group by the U.S. FDA.
|
Sustained MPH
n=17 participants at risk
1. Double-blind (DB) placebo-controlled 4-week methylphenidate (MPH) titration trial. Pts will receive 3 active dosages of MPH (children \<25kg: 18mg, 27mg, 36mg; children \>25kg: 18mg, 36mg, 54mg for) as well as 1 random week of placebo, given qAM. Pts will begin on the lowest dose (or a randomized placebo week) and proceed through all dose conditions in an incremental fashion.
2. DB 4-week MPH maintenance phase. The clinician, parent, and teacher ratings of behavior and side effects from the titration trial weeks will be graphed. Two doctors will blindly review the graphs and judge which week was the optimal dose week. Pts will then receive their optimal dose of MPH (qAM) for 4 weeks.
3. DB 4-week MPH Discontinuation Phase. Pts in this arm will continue their optimal MPH dose (qAM).
OROS-Methylphenidate (MPH): OROS-methylphenidate will be taken orally once daily at doses that have been approved for the study age group by the U.S. FDA.
|
|---|---|---|
|
Psychiatric disorders
Suicidal Ideation
|
1.1%
1/92 • Number of events 1 • Duration of trial (3 months)
1. All-Cause Mortality: The occurrence of death due to any cause. 2. Serious Adverse Events: adverse events resulting: death, life-threatening event, inpatient hospitalization, significant incapacity, inability to conduct normal functions, or a congenital anomaly. Important medical events may also be considered serious when they require medical or surgical intervention to prevent one of the outcomes listed in this definition. 3. Other: Adverse events that are not Serious Adverse Events.
|
0.00%
0/17 • Duration of trial (3 months)
1. All-Cause Mortality: The occurrence of death due to any cause. 2. Serious Adverse Events: adverse events resulting: death, life-threatening event, inpatient hospitalization, significant incapacity, inability to conduct normal functions, or a congenital anomaly. Important medical events may also be considered serious when they require medical or surgical intervention to prevent one of the outcomes listed in this definition. 3. Other: Adverse events that are not Serious Adverse Events.
|
Other adverse events
| Measure |
MPH Discontinuation
n=92 participants at risk
1. Double-blind (DB) placebo-controlled 4-week methylphenidate (MPH) titration trial. Pts will receive 3 active dosages of MPH (children \<25kg: 18mg, 27mg, 36mg; children \>25kg: 18mg, 36mg, 54mg for) as well as 1 random week of placebo, given qAM. Pts will begin on the lowest dose (or a randomized placebo week) and proceed through all dose conditions in an incremental fashion.
2. DB 4-week MPH maintenance phase. The clinician, parent, and teacher ratings of behavior and side effects from the titration trial weeks will be graphed. Two doctors will blindly review the graphs and judge which week was the optimal dose week. Pts will then receive their optimal dose of MPH (qAM) for 4 weeks.
3. DB 4-week MPH Discontinuation Phase. Pts in this arm will receive placebo (qAM).
OROS-Methylphenidate (MPH): OROS-methylphenidate will be taken orally once daily at doses that have been approved for the study age group by the U.S. FDA.
|
Sustained MPH
n=17 participants at risk
1. Double-blind (DB) placebo-controlled 4-week methylphenidate (MPH) titration trial. Pts will receive 3 active dosages of MPH (children \<25kg: 18mg, 27mg, 36mg; children \>25kg: 18mg, 36mg, 54mg for) as well as 1 random week of placebo, given qAM. Pts will begin on the lowest dose (or a randomized placebo week) and proceed through all dose conditions in an incremental fashion.
2. DB 4-week MPH maintenance phase. The clinician, parent, and teacher ratings of behavior and side effects from the titration trial weeks will be graphed. Two doctors will blindly review the graphs and judge which week was the optimal dose week. Pts will then receive their optimal dose of MPH (qAM) for 4 weeks.
3. DB 4-week MPH Discontinuation Phase. Pts in this arm will continue their optimal MPH dose (qAM).
OROS-Methylphenidate (MPH): OROS-methylphenidate will be taken orally once daily at doses that have been approved for the study age group by the U.S. FDA.
|
|---|---|---|
|
Gastrointestinal disorders
Decreased appetite
|
17.4%
16/92 • Number of events 16 • Duration of trial (3 months)
1. All-Cause Mortality: The occurrence of death due to any cause. 2. Serious Adverse Events: adverse events resulting: death, life-threatening event, inpatient hospitalization, significant incapacity, inability to conduct normal functions, or a congenital anomaly. Important medical events may also be considered serious when they require medical or surgical intervention to prevent one of the outcomes listed in this definition. 3. Other: Adverse events that are not Serious Adverse Events.
|
58.8%
10/17 • Number of events 10 • Duration of trial (3 months)
1. All-Cause Mortality: The occurrence of death due to any cause. 2. Serious Adverse Events: adverse events resulting: death, life-threatening event, inpatient hospitalization, significant incapacity, inability to conduct normal functions, or a congenital anomaly. Important medical events may also be considered serious when they require medical or surgical intervention to prevent one of the outcomes listed in this definition. 3. Other: Adverse events that are not Serious Adverse Events.
|
|
Nervous system disorders
Headache
|
6.5%
6/92 • Number of events 6 • Duration of trial (3 months)
1. All-Cause Mortality: The occurrence of death due to any cause. 2. Serious Adverse Events: adverse events resulting: death, life-threatening event, inpatient hospitalization, significant incapacity, inability to conduct normal functions, or a congenital anomaly. Important medical events may also be considered serious when they require medical or surgical intervention to prevent one of the outcomes listed in this definition. 3. Other: Adverse events that are not Serious Adverse Events.
|
17.6%
3/17 • Number of events 3 • Duration of trial (3 months)
1. All-Cause Mortality: The occurrence of death due to any cause. 2. Serious Adverse Events: adverse events resulting: death, life-threatening event, inpatient hospitalization, significant incapacity, inability to conduct normal functions, or a congenital anomaly. Important medical events may also be considered serious when they require medical or surgical intervention to prevent one of the outcomes listed in this definition. 3. Other: Adverse events that are not Serious Adverse Events.
|
|
Gastrointestinal disorders
Stomachache
|
8.7%
8/92 • Number of events 8 • Duration of trial (3 months)
1. All-Cause Mortality: The occurrence of death due to any cause. 2. Serious Adverse Events: adverse events resulting: death, life-threatening event, inpatient hospitalization, significant incapacity, inability to conduct normal functions, or a congenital anomaly. Important medical events may also be considered serious when they require medical or surgical intervention to prevent one of the outcomes listed in this definition. 3. Other: Adverse events that are not Serious Adverse Events.
|
5.9%
1/17 • Number of events 1 • Duration of trial (3 months)
1. All-Cause Mortality: The occurrence of death due to any cause. 2. Serious Adverse Events: adverse events resulting: death, life-threatening event, inpatient hospitalization, significant incapacity, inability to conduct normal functions, or a congenital anomaly. Important medical events may also be considered serious when they require medical or surgical intervention to prevent one of the outcomes listed in this definition. 3. Other: Adverse events that are not Serious Adverse Events.
|
|
General disorders
Trouble Sleeping
|
14.1%
13/92 • Number of events 13 • Duration of trial (3 months)
1. All-Cause Mortality: The occurrence of death due to any cause. 2. Serious Adverse Events: adverse events resulting: death, life-threatening event, inpatient hospitalization, significant incapacity, inability to conduct normal functions, or a congenital anomaly. Important medical events may also be considered serious when they require medical or surgical intervention to prevent one of the outcomes listed in this definition. 3. Other: Adverse events that are not Serious Adverse Events.
|
23.5%
4/17 • Number of events 4 • Duration of trial (3 months)
1. All-Cause Mortality: The occurrence of death due to any cause. 2. Serious Adverse Events: adverse events resulting: death, life-threatening event, inpatient hospitalization, significant incapacity, inability to conduct normal functions, or a congenital anomaly. Important medical events may also be considered serious when they require medical or surgical intervention to prevent one of the outcomes listed in this definition. 3. Other: Adverse events that are not Serious Adverse Events.
|
|
Psychiatric disorders
Irritability
|
18.5%
17/92 • Number of events 17 • Duration of trial (3 months)
1. All-Cause Mortality: The occurrence of death due to any cause. 2. Serious Adverse Events: adverse events resulting: death, life-threatening event, inpatient hospitalization, significant incapacity, inability to conduct normal functions, or a congenital anomaly. Important medical events may also be considered serious when they require medical or surgical intervention to prevent one of the outcomes listed in this definition. 3. Other: Adverse events that are not Serious Adverse Events.
|
23.5%
4/17 • Number of events 4 • Duration of trial (3 months)
1. All-Cause Mortality: The occurrence of death due to any cause. 2. Serious Adverse Events: adverse events resulting: death, life-threatening event, inpatient hospitalization, significant incapacity, inability to conduct normal functions, or a congenital anomaly. Important medical events may also be considered serious when they require medical or surgical intervention to prevent one of the outcomes listed in this definition. 3. Other: Adverse events that are not Serious Adverse Events.
|
|
Psychiatric disorders
Social Withdrawal
|
2.2%
2/92 • Number of events 2 • Duration of trial (3 months)
1. All-Cause Mortality: The occurrence of death due to any cause. 2. Serious Adverse Events: adverse events resulting: death, life-threatening event, inpatient hospitalization, significant incapacity, inability to conduct normal functions, or a congenital anomaly. Important medical events may also be considered serious when they require medical or surgical intervention to prevent one of the outcomes listed in this definition. 3. Other: Adverse events that are not Serious Adverse Events.
|
5.9%
1/17 • Number of events 1 • Duration of trial (3 months)
1. All-Cause Mortality: The occurrence of death due to any cause. 2. Serious Adverse Events: adverse events resulting: death, life-threatening event, inpatient hospitalization, significant incapacity, inability to conduct normal functions, or a congenital anomaly. Important medical events may also be considered serious when they require medical or surgical intervention to prevent one of the outcomes listed in this definition. 3. Other: Adverse events that are not Serious Adverse Events.
|
|
Psychiatric disorders
Sadness
|
5.4%
5/92 • Number of events 5 • Duration of trial (3 months)
1. All-Cause Mortality: The occurrence of death due to any cause. 2. Serious Adverse Events: adverse events resulting: death, life-threatening event, inpatient hospitalization, significant incapacity, inability to conduct normal functions, or a congenital anomaly. Important medical events may also be considered serious when they require medical or surgical intervention to prevent one of the outcomes listed in this definition. 3. Other: Adverse events that are not Serious Adverse Events.
|
17.6%
3/17 • Number of events 3 • Duration of trial (3 months)
1. All-Cause Mortality: The occurrence of death due to any cause. 2. Serious Adverse Events: adverse events resulting: death, life-threatening event, inpatient hospitalization, significant incapacity, inability to conduct normal functions, or a congenital anomaly. Important medical events may also be considered serious when they require medical or surgical intervention to prevent one of the outcomes listed in this definition. 3. Other: Adverse events that are not Serious Adverse Events.
|
|
General disorders
Dull, tired, listless
|
9.8%
9/92 • Number of events 9 • Duration of trial (3 months)
1. All-Cause Mortality: The occurrence of death due to any cause. 2. Serious Adverse Events: adverse events resulting: death, life-threatening event, inpatient hospitalization, significant incapacity, inability to conduct normal functions, or a congenital anomaly. Important medical events may also be considered serious when they require medical or surgical intervention to prevent one of the outcomes listed in this definition. 3. Other: Adverse events that are not Serious Adverse Events.
|
17.6%
3/17 • Number of events 3 • Duration of trial (3 months)
1. All-Cause Mortality: The occurrence of death due to any cause. 2. Serious Adverse Events: adverse events resulting: death, life-threatening event, inpatient hospitalization, significant incapacity, inability to conduct normal functions, or a congenital anomaly. Important medical events may also be considered serious when they require medical or surgical intervention to prevent one of the outcomes listed in this definition. 3. Other: Adverse events that are not Serious Adverse Events.
|
|
Psychiatric disorders
Skin-picking
|
14.1%
13/92 • Number of events 13 • Duration of trial (3 months)
1. All-Cause Mortality: The occurrence of death due to any cause. 2. Serious Adverse Events: adverse events resulting: death, life-threatening event, inpatient hospitalization, significant incapacity, inability to conduct normal functions, or a congenital anomaly. Important medical events may also be considered serious when they require medical or surgical intervention to prevent one of the outcomes listed in this definition. 3. Other: Adverse events that are not Serious Adverse Events.
|
5.9%
1/17 • Number of events 1 • Duration of trial (3 months)
1. All-Cause Mortality: The occurrence of death due to any cause. 2. Serious Adverse Events: adverse events resulting: death, life-threatening event, inpatient hospitalization, significant incapacity, inability to conduct normal functions, or a congenital anomaly. Important medical events may also be considered serious when they require medical or surgical intervention to prevent one of the outcomes listed in this definition. 3. Other: Adverse events that are not Serious Adverse Events.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/92 • Duration of trial (3 months)
1. All-Cause Mortality: The occurrence of death due to any cause. 2. Serious Adverse Events: adverse events resulting: death, life-threatening event, inpatient hospitalization, significant incapacity, inability to conduct normal functions, or a congenital anomaly. Important medical events may also be considered serious when they require medical or surgical intervention to prevent one of the outcomes listed in this definition. 3. Other: Adverse events that are not Serious Adverse Events.
|
5.9%
1/17 • Number of events 1 • Duration of trial (3 months)
1. All-Cause Mortality: The occurrence of death due to any cause. 2. Serious Adverse Events: adverse events resulting: death, life-threatening event, inpatient hospitalization, significant incapacity, inability to conduct normal functions, or a congenital anomaly. Important medical events may also be considered serious when they require medical or surgical intervention to prevent one of the outcomes listed in this definition. 3. Other: Adverse events that are not Serious Adverse Events.
|
Additional Information
Tanya Froehlich, MD
Cincinnati Children's Hospital Medical Center
Phone: 5136361154
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place