Trial Outcomes & Findings for Neuroimaging the Expectancy Versus Pharmacotherapy Effect of Adderall on Cognitive Performance (NCT NCT03530631)
NCT ID: NCT03530631
Last Updated: 2019-12-16
Results Overview
Using a balanced placebo design, participants were either administered mixed amphetamine salts or placebo. Their cognitive performance was assessed in the MRI scanner. The main outcome measure was the feasibility of participants attending four neuroimaging sessions.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
4 participants
Primary outcome timeframe
A total of 4 imagining sessions, an average of 60 minutes each
Results posted on
2019-12-16
Participant Flow
Only four subjects were recruited for this pilot study
Participant milestones
| Measure |
Adderall Within Subjects Design
This is a within-subjects design in which participants will complete all four periods/conditions. For two sessions, participants will be accurately told that they are receiving Adderall or placebo, respectively. For two sessions, participants will be inaccurately informed that they are receiving Adderall or placebo. The participants will be counterbalanced across conditions to control for order effects.
|
|---|---|
|
Adderall/Truth
STARTED
|
4
|
|
Adderall/Truth
COMPLETED
|
4
|
|
Adderall/Truth
NOT COMPLETED
|
0
|
|
Placebo/Truth
STARTED
|
4
|
|
Placebo/Truth
COMPLETED
|
4
|
|
Placebo/Truth
NOT COMPLETED
|
0
|
|
Adderall/Deception
STARTED
|
4
|
|
Adderall/Deception
COMPLETED
|
4
|
|
Adderall/Deception
NOT COMPLETED
|
0
|
|
Placebo/Deception
STARTED
|
4
|
|
Placebo/Deception
COMPLETED
|
4
|
|
Placebo/Deception
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Neuroimaging the Expectancy Versus Pharmacotherapy Effect of Adderall on Cognitive Performance
Baseline characteristics by cohort
| Measure |
Adderall Within Subjects Design
n=4 Participants
This is a within-subjects design in which participants will complete all four periods/conditions. For two sessions, participants will be accurately told that they are receiving Adderall or placebo, respectively. For two sessions, participants will be inaccurately informed that they are receiving Adderall or placebo. The participants will be counterbalanced across conditions to control for order effects.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 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
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 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
|
4 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: A total of 4 imagining sessions, an average of 60 minutes eachUsing a balanced placebo design, participants were either administered mixed amphetamine salts or placebo. Their cognitive performance was assessed in the MRI scanner. The main outcome measure was the feasibility of participants attending four neuroimaging sessions.
Outcome measures
| Measure |
Adderall/Truth
n=4 Participants
Participants will be told they are receiving Adderall and will actually be administered Adderall.
Adderall: Participants will be administered Adderall
|
Placebo/Truth
n=4 Participants
Participants will be told they are receiving placebo and will actually be administered placebo.
Placebo: Participants will be administered placebo
|
Adderall/Deception
n=4 Participants
Participants will be told they are receiving Adderall and will actually be administered placebo.
Placebo: Participants will be administered placebo
|
Placebo/Deception
n=4 Participants
Participants will be told they are receiving placebo and will actually be administered Adderall.
Adderall: Participants will be administered Adderall
|
|---|---|---|---|---|
|
Number of Participants Consistently Attending and Completing Four Neuroimaging Sessions
|
4 Participants
|
4 Participants
|
4 Participants
|
4 Participants
|
Adverse Events
Adderall/Truth
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo/Truth
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Adderall/Deception
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo/Deception
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