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Trial Outcomes & Findings for Motivated Behavior in Adults With and Without ADHD (NCT NCT02630017)

NCT ID: NCT02630017

Last Updated: 2021-08-27

Results Overview

Number of high-effort selections in the effort-based decision making task from the placebo to the methylphenidate condition. This is a decision-making task where participants make high- or low-effort choices to earn a small financial reward. High-effort selections require 100 button presses with non-dominant hand pinky finger and low-effort selections require 30 button presses with dominant hand index finger (within 15 seconds). The number of high effort selections are summed across 50 trials of the task. This task measures the willingness to perform effort in relation to changing reward magnitude and probability. This is a basic science experiment, the clinical and/or physiological relevance of these results are not established.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

51 participants

Primary outcome timeframe

1 hour post drug (or placebo) administration for each study session

Results posted on

2021-08-27

Participant Flow

Within each study arm (ADHD or non-ADHD subjects), subjects were exposed to placebo and drug (each at a different timepoint in the study). Approximately half of the subjects within each arm received drug first and half received placebo first (i.e., order was counterbalanced).

Participant milestones

Participant milestones
Measure
ADHD Methylphenidate First, Placebo Second
Adults with ADHD who received drug (methylphenidate) first, followed by placebo
ADHD Placebo First, Methylphenidate Second
Adults with ADHD who received placebo first, followed by drug (methylphenidate)
Non-ADHD Methylphenidate First, Placebo Second
Adults without ADHD who received drug (methylphenidate) first, followed by placebo
Non-ADHD Placebo First, Methylphenidate Second
Adults without ADHD who received placebo first, followed by drug (methylphenidate)
Overall Study
STARTED
13
12
13
13
Overall Study
COMPLETED
12
11
11
12
Overall Study
NOT COMPLETED
1
1
2
1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Motivated Behavior in Adults With and Without ADHD

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
ADHD
n=23 Participants
Adults with ADHD
Non-ADHD
n=23 Participants
Adults without ADHD
Total
n=46 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
23 Participants
n=5 Participants
23 Participants
n=7 Participants
46 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Continuous
33 years
STANDARD_DEVIATION 8 • n=5 Participants
28 years
STANDARD_DEVIATION 7 • n=7 Participants
31 years
STANDARD_DEVIATION 8 • n=5 Participants
Sex: Female, Male
Female
12 Participants
n=5 Participants
12 Participants
n=7 Participants
24 Participants
n=5 Participants
Sex: Female, Male
Male
11 Participants
n=5 Participants
11 Participants
n=7 Participants
22 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
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 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
0 Participants
n=5 Participants
7 Participants
n=7 Participants
7 Participants
n=5 Participants
Race (NIH/OMB)
White
18 Participants
n=5 Participants
12 Participants
n=7 Participants
30 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
5 Participants
n=5 Participants
4 Participants
n=7 Participants
9 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
23 participants
n=5 Participants
23 participants
n=7 Participants
46 participants
n=5 Participants

PRIMARY outcome

Timeframe: 1 hour post drug (or placebo) administration for each study session

Population: Approximately half of the subjects within each arm (ADHD or non-ADHD) received drug first and half received placebo first (i.e., order was counterbalanced). The study was powered to compare two groups (ADHD vs non-ADHD). Since order of drug was counterbalanced, this means all ADHD subjects were evaluated under both placebo and drug conditions, and this is also true for the non-ADHD subjects.

Number of high-effort selections in the effort-based decision making task from the placebo to the methylphenidate condition. This is a decision-making task where participants make high- or low-effort choices to earn a small financial reward. High-effort selections require 100 button presses with non-dominant hand pinky finger and low-effort selections require 30 button presses with dominant hand index finger (within 15 seconds). The number of high effort selections are summed across 50 trials of the task. This task measures the willingness to perform effort in relation to changing reward magnitude and probability. This is a basic science experiment, the clinical and/or physiological relevance of these results are not established.

Outcome measures

Outcome measures
Measure
ADHD Subjects, Placebo Condition
n=23 Participants
Adults with ADHD, under the placebo condition
ADHD Subjects, Methylphenidate Condition
n=23 Participants
Adults with ADHD, under the methylphenidate (drug) condition
Non-ADHD Subjects, Placebo Condition
n=23 Participants
Adults without ADHD, under the placebo condition
Non-ADHD Subjects, Methylphenidate Condition
n=23 Participants
Adults without ADHD, under the methylphenidate (drug) condition
Number of High-effort Selections in the Effort-based Decision Making Task
16.4 Number of high-effort selections
Standard Error 2.2
21.35 Number of high-effort selections
Standard Error 1.9
20.45 Number of high-effort selections
Standard Error 2.2
19.8 Number of high-effort selections
Standard Error 1.9

Adverse Events

ADHD Methylphenidate First, Placebo Second

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

ADHD Placebo First, Methylphenidate Second

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

Non-ADHD Methylphenidate First, Placebo Second

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

Non-ADHD Placebo First, Methylphenidate Second

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

Merideth Addicott

University of Arkansas for Medical Sciences

Phone: 501-526-8436

Results disclosure agreements

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