Trial Outcomes & Findings for Behavioral Differences in Effortful Control (NCT NCT01852344)
NCT ID: NCT01852344
Last Updated: 2018-01-08
Results Overview
Reaction time on the Multi-Source Interference Task is measured in milliseconds. Participants were given 200 trials and their mean reaction time was calculated.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
108 participants
Primary outcome timeframe
20-30 minutes for task completion
Results posted on
2018-01-08
Participant Flow
Participant milestones
| Measure |
Placebo Easy
Healthy participants are given a placebo (sugar pill) one hour before task performance and complete an easy version of the Letter E task.
|
Placebo Hard
Healthy participants are given a placebo (sugar pill) one hour before task performance and complete a hard version of the Letter E task.
|
Methylphenidate Easy
Participants are given 20 mgs of methylphenidate one hour before task performance and complete an easy version of the Letter E task.
|
Methylphenidate Hard
Healthy participants are given 20 mgs of methylphenidate one hour before task performance and complete a hard version of the Letter E task.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
27
|
27
|
27
|
27
|
|
Overall Study
Actual Participation in First Assignment
|
27
|
27
|
27
|
27
|
|
Overall Study
COMPLETED
|
27
|
27
|
27
|
27
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Participants who had more than 20% error on the Letter E task were excluded from analysis.
Baseline characteristics by cohort
| Measure |
Placebo Easy
n=27 Participants
Healthy participants are given a placebo (sugar pill) one hour before task performance and complete an easy version of the Letter E task.
|
Placebo Hard
n=27 Participants
Healthy participants are given 20 mgs of Methylphenidate one hour before task performance and complete a hard version of the Letter E task.
|
Methylphenidate Easy
n=27 Participants
Healthy participants are given 20 mgs of Methylphenidate one hour before task performance and complete an easy version of the Letter E task.
|
Methylphenidate Hard
n=27 Participants
Healthy participants are given 20 mgs of Methylphenidate one hour before task performance and complete a hard version of the Letter E task.
|
Total
n=108 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=24 Participants • Participants who had more than 20% error on the Letter E task were excluded from analysis.
|
0 Participants
n=23 Participants • Participants who had more than 20% error on the Letter E task were excluded from analysis.
|
0 Participants
n=23 Participants • Participants who had more than 20% error on the Letter E task were excluded from analysis.
|
0 Participants
n=24 Participants • Participants who had more than 20% error on the Letter E task were excluded from analysis.
|
0 Participants
n=94 Participants • Participants who had more than 20% error on the Letter E task were excluded from analysis.
|
|
Age, Categorical
Between 18 and 65 years
|
24 Participants
n=24 Participants • Participants who had more than 20% error on the Letter E task were excluded from analysis.
|
23 Participants
n=23 Participants • Participants who had more than 20% error on the Letter E task were excluded from analysis.
|
23 Participants
n=23 Participants • Participants who had more than 20% error on the Letter E task were excluded from analysis.
|
24 Participants
n=24 Participants • Participants who had more than 20% error on the Letter E task were excluded from analysis.
|
94 Participants
n=94 Participants • Participants who had more than 20% error on the Letter E task were excluded from analysis.
|
|
Age, Categorical
>=65 years
|
0 Participants
n=24 Participants • Participants who had more than 20% error on the Letter E task were excluded from analysis.
|
0 Participants
n=23 Participants • Participants who had more than 20% error on the Letter E task were excluded from analysis.
|
0 Participants
n=23 Participants • Participants who had more than 20% error on the Letter E task were excluded from analysis.
|
0 Participants
n=24 Participants • Participants who had more than 20% error on the Letter E task were excluded from analysis.
|
0 Participants
n=94 Participants • Participants who had more than 20% error on the Letter E task were excluded from analysis.
|
|
Age, Continuous
|
28.2 years
STANDARD_DEVIATION 4.8 • n=24 Participants • Participants with greater than 20% error on the Letter E task were excluded from analysis.
|
25.8 years
STANDARD_DEVIATION 2.0 • n=23 Participants • Participants with greater than 20% error on the Letter E task were excluded from analysis.
|
26.9 years
STANDARD_DEVIATION 4.3 • n=23 Participants • Participants with greater than 20% error on the Letter E task were excluded from analysis.
|
26.6 years
STANDARD_DEVIATION 3.4 • n=24 Participants • Participants with greater than 20% error on the Letter E task were excluded from analysis.
|
26.9 years
STANDARD_DEVIATION 3.8 • n=94 Participants • Participants with greater than 20% error on the Letter E task were excluded from analysis.
|
|
Sex: Female, Male
Female
|
17 Participants
n=24 Participants • Participants who had greater than 20% error on the Letter E task were excluded from analysis.
|
15 Participants
n=23 Participants • Participants who had greater than 20% error on the Letter E task were excluded from analysis.
|
14 Participants
n=23 Participants • Participants who had greater than 20% error on the Letter E task were excluded from analysis.
|
13 Participants
n=24 Participants • Participants who had greater than 20% error on the Letter E task were excluded from analysis.
|
59 Participants
n=94 Participants • Participants who had greater than 20% error on the Letter E task were excluded from analysis.
|
|
Sex: Female, Male
Male
|
7 Participants
n=24 Participants • Participants who had greater than 20% error on the Letter E task were excluded from analysis.
|
8 Participants
n=23 Participants • Participants who had greater than 20% error on the Letter E task were excluded from analysis.
|
9 Participants
n=23 Participants • Participants who had greater than 20% error on the Letter E task were excluded from analysis.
|
11 Participants
n=24 Participants • Participants who had greater than 20% error on the Letter E task were excluded from analysis.
|
35 Participants
n=94 Participants • Participants who had greater than 20% error on the Letter E task were excluded from analysis.
|
|
Region of Enrollment
United States
|
24 Participants
n=24 Participants • Participants with greater than 20% error on the Letter E task were excluded from analysis.
|
23 Participants
n=23 Participants • Participants with greater than 20% error on the Letter E task were excluded from analysis.
|
23 Participants
n=23 Participants • Participants with greater than 20% error on the Letter E task were excluded from analysis.
|
24 Participants
n=24 Participants • Participants with greater than 20% error on the Letter E task were excluded from analysis.
|
94 Participants
n=94 Participants • Participants with greater than 20% error on the Letter E task were excluded from analysis.
|
PRIMARY outcome
Timeframe: 20-30 minutes for task completionPopulation: Participants whose accuracy on task one fell below 80% or who were greater than two standard deviation outliers in reaction time were excluded from analysis.
Reaction time on the Multi-Source Interference Task is measured in milliseconds. Participants were given 200 trials and their mean reaction time was calculated.
Outcome measures
| Measure |
Placebo Easy
n=24 Participants
Healthy participants are given a placebo (sugar pill) one hour before task performance and complete an easy version of the Letter E task.
|
Placebo Hard
n=23 Participants
Healthy participants are given a placebo (sugar pill) one hour before task performance and complete a hard version of the Letter E task.
|
Methylphenidate Easy
n=23 Participants
Healthy participants are given 20 mgs of Methylphenidate one hour before task performance and complete an easy version of the Letter E task.
|
Methylphenidate Hard
n=24 Participants
Healthy participants are given 20 mgs of Methylphenidate one hour before task performance and complete a hard version of the Letter E task.
|
|---|---|---|---|---|
|
Reaction Time on the Multi-Source Interference Task
|
300 milliseconds
Standard Deviation 70
|
330 milliseconds
Standard Deviation 90
|
310 milliseconds
Standard Deviation 80
|
280 milliseconds
Standard Deviation 70
|
SECONDARY outcome
Timeframe: 20-30 minutesPopulation: Participants whose accuracy on task one fell below 80% or who were greater than two standard deviation outliers in reaction time were excluded from analysis.
Patients completed 200 trials and the percentage of answers correct was calculated.
Outcome measures
| Measure |
Placebo Easy
n=24 Participants
Healthy participants are given a placebo (sugar pill) one hour before task performance and complete an easy version of the Letter E task.
|
Placebo Hard
n=23 Participants
Healthy participants are given a placebo (sugar pill) one hour before task performance and complete a hard version of the Letter E task.
|
Methylphenidate Easy
n=23 Participants
Healthy participants are given 20 mgs of Methylphenidate one hour before task performance and complete an easy version of the Letter E task.
|
Methylphenidate Hard
n=24 Participants
Healthy participants are given 20 mgs of Methylphenidate one hour before task performance and complete a hard version of the Letter E task.
|
|---|---|---|---|---|
|
Accuracy on the Multi-Source Interference Task.
|
94.1 percentage of answers which were correct
Standard Deviation 3.5
|
94.3 percentage of answers which were correct
Standard Deviation 5.3
|
96.1 percentage of answers which were correct
Standard Deviation 3.2
|
96.6 percentage of answers which were correct
Standard Deviation 3.2
|
SECONDARY outcome
Timeframe: 20-30 minutesPopulation: Participants whose accuracy on task one fell below 80% or who were greater than two standard deviation outliers in reaction time were excluded from analysis.
Reaction time variability on the Multi-Source Interference task is defined as the number of milliseconds between an individual's lowest and highest reaction time. This is averaged across all participants.
Outcome measures
| Measure |
Placebo Easy
n=24 Participants
Healthy participants are given a placebo (sugar pill) one hour before task performance and complete an easy version of the Letter E task.
|
Placebo Hard
n=23 Participants
Healthy participants are given a placebo (sugar pill) one hour before task performance and complete a hard version of the Letter E task.
|
Methylphenidate Easy
n=23 Participants
Healthy participants are given 20 mgs of Methylphenidate one hour before task performance and complete an easy version of the Letter E task.
|
Methylphenidate Hard
n=24 Participants
Healthy participants are given 20 mgs of Methylphenidate one hour before task performance and complete a hard version of the Letter E task.
|
|---|---|---|---|---|
|
Reaction Time Variability on the Multi-Source Interference Task.
|
270 milliseconds
Standard Deviation 50
|
320 milliseconds
Standard Deviation 70
|
270 milliseconds
Standard Deviation 70
|
260 milliseconds
Standard Deviation 40
|
Adverse Events
Placebo Easy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Hard
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Methylphenidate Easy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Methylphenidate Hard
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place