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Trial Outcomes & Findings for Attention Deficit Disorder Medication Response Study (NCT NCT01727414)

NCT ID: NCT01727414

Last Updated: 2021-05-18

Results Overview

Assessed via parent and teacher Vanderbilt Attention Deficit Hyperactivity Disorder Rating Scales which were completed each the 4 weeks of the titration trial. Range: min=0, max=54 \[sum of 18 symptom items, rated from 0 (none), 1 (occasionally), 2 (often), 3 (very often)\], higher scores indicate worse outcomes. Note to address Review Comment: During the 4 week titration trial, the placebo condition and each of the three active dosages (low, medium, and high) were given for one week each. Because the placebo and active dosages were given in random order to preserve the triple blind, all participants did not receive the same order of dosages and it is not possible to connect the dosages (placebo, low dose MPH, medium dose MPH, high dose MPH) to a specific week number (week 1, week 2, week 3, week 4) which would hold for ALL participants. That is why Timeframe was revised from "week 1, week 2, week 3, week 4" to placebo, low dose, medium dose, and high dose week.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

171 participants

Primary outcome timeframe

End of placebo dose week, End of low dose week, End of medium dose week , End of high dose week

Results posted on

2021-05-18

Participant Flow

Participant milestones

Participant milestones
Measure
Inattentive Type
Every participant receives low dose MPH, medium dose MPH, high dose MPH, and placebo for one week each in a triple-blinded fashion. Placebo: capsule, frequency - each AM, duration - 1 week
Combined Type
Every participant receives low dose MPH, medium dose MPH, high dose MPH, and placebo for one week each in a triple-blinded fashion. OROS-Methylphenidate: capsule; dosages - 18mg, 27mg, 36mg, 54 mg; frequency - each AM; duration - one week for each dose, with each child receiving 3 doses \[children \< 25 kg receive 18mg, 27mg, 36mg; children \> or = to 25kg get 18mg, 36mg, 54mg\]
Overall Study
STARTED
126
45
Overall Study
COMPLETED
123
45
Overall Study
NOT COMPLETED
3
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Attention Deficit Disorder Medication Response Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Inattentive Type
n=126 Participants
Combined Type
n=45 Participants
Total
n=171 Participants
Total of all reporting groups
Age, Continuous
8.6 years
STANDARD_DEVIATION 1.3 • n=5 Participants
7.9 years
STANDARD_DEVIATION 1.0 • n=7 Participants
8.4 years
STANDARD_DEVIATION 1.3 • n=5 Participants
Sex: Female, Male
Female
40 Participants
n=5 Participants
9 Participants
n=7 Participants
49 Participants
n=5 Participants
Sex: Female, Male
Male
86 Participants
n=5 Participants
36 Participants
n=7 Participants
122 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants
n=5 Participants
0 Participants
n=7 Participants
1 Participants
n=5 Participants
Race (NIH/OMB)
Asian
2 Participants
n=5 Participants
0 Participants
n=7 Participants
2 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
6 Participants
n=5 Participants
15 Participants
n=7 Participants
21 Participants
n=5 Participants
Race (NIH/OMB)
White
109 Participants
n=5 Participants
30 Participants
n=7 Participants
139 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
8 Participants
n=5 Participants
0 Participants
n=7 Participants
8 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

PRIMARY outcome

Timeframe: End of placebo dose week, End of low dose week, End of medium dose week , End of high dose week

Assessed via parent and teacher Vanderbilt Attention Deficit Hyperactivity Disorder Rating Scales which were completed each the 4 weeks of the titration trial. Range: min=0, max=54 \[sum of 18 symptom items, rated from 0 (none), 1 (occasionally), 2 (often), 3 (very often)\], higher scores indicate worse outcomes. Note to address Review Comment: During the 4 week titration trial, the placebo condition and each of the three active dosages (low, medium, and high) were given for one week each. Because the placebo and active dosages were given in random order to preserve the triple blind, all participants did not receive the same order of dosages and it is not possible to connect the dosages (placebo, low dose MPH, medium dose MPH, high dose MPH) to a specific week number (week 1, week 2, week 3, week 4) which would hold for ALL participants. That is why Timeframe was revised from "week 1, week 2, week 3, week 4" to placebo, low dose, medium dose, and high dose week.

Outcome measures

Outcome measures
Measure
Inattentive Type
n=123 Participants
Every participant receives low dose MPH, medium dose MPH, high dose MPH, and placebo for one week each in a triple-blinded fashion. OROS-Methylphenidate: capsule; dosages - 18mg, 27mg, 36mg, 54 mg; frequency - each AM; duration - one week for each dose, with each child receiving 3 doses \[children \< 25 kg receive 18mg, 27mg, 36mg; children \> or = to 25kg get 18mg, 36mg, 54mg\]
Combined Type
n=45 Participants
Every participant receives low dose MPH, medium dose MPH, high dose MPH, and placebo for one week each in a triple-blinded fashion. OROS-Methylphenidate: capsule; dosages - 18mg, 27mg, 36mg, 54 mg; frequency - each AM; duration - one week for each dose, with each child receiving 3 doses \[children \< 25 kg receive 18mg, 27mg, 36mg; children \> or = to 25kg get 18mg, 36mg, 54mg\]
Attention Deficit Hyperactivity Disorder Total Symptom Score
ADHD Total Symptom Score on Placebo
21.4 units on a scale
Standard Deviation 8.9
30.0 units on a scale
Standard Deviation 9.2
Attention Deficit Hyperactivity Disorder Total Symptom Score
ADHD Total Symptom Score on Low Dose MPH
20.2 units on a scale
Standard Deviation 8.1
29.7 units on a scale
Standard Deviation 10.6
Attention Deficit Hyperactivity Disorder Total Symptom Score
ADHD Total Symptom Score on Medium Dose MPH
17.0 units on a scale
Standard Deviation 7.9
23.9 units on a scale
Standard Deviation 10.7
Attention Deficit Hyperactivity Disorder Total Symptom Score
ADHD Total Symptom Score on High Dose MPH
15.5 units on a scale
Standard Deviation 6.9
22.8 units on a scale
Standard Deviation 10.8

Adverse Events

Inattentive Type

Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths

Combined Type

Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Inattentive Type
n=123 participants at risk
Children meeting DSM-IV criteria for ADHD-inattentive type.
Combined Type
n=45 participants at risk
Children meeting DSM-IV criteria for ADHD-combined type.
Nervous system disorders
Irritability
13.8%
17/123 • Number of events 17 • 4 week medication titration trial
17.8%
8/45 • Number of events 8 • 4 week medication titration trial

Additional Information

Tanya Froehlich

Cincinnati Children's Hospital

Phone: 5136361154

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place