Trial · NCT01924429

Neurobiological Basis of Response to Vyvanse in Adults With ADHD: an fMRI Study of Brain Activation

NCT01924429, Phase 4, Completed, Jeffrey Newcorn; results first posted 2018-06-06

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Neurobiological Basis of Response to Vyvanse in Adults With ADHD: an fMRI Study of Brain Activation. Trials, record NCT01924429. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01924429

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Neurobiological Basis of Response to Vyvanse in Adults With ADHD: an fMRI Study of Brain Activation
NCT number: NCT01924429
Status: Completed
Phases: Phase 4
Enrollment: 30 participants, actual
Lead sponsor: Jeffrey Newcorn
Conditions: ADHD
Interventions: Lisdexamfetamine
First posted: 2013-08-16
Last updated: 2018-06-06
Results first posted: 2018-06-06

Source ClinicalTrials.gov

Registered outcomes13

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	The Go/No-Go Task Percentage Assessed by fMRI	8 weeks	Performance Measures on the Go/No-Go Task assessed by fMRI as a Function of Trial Type, Face Emotion, and Drug Condition in Adults with Attention-Deficit/Hyperactivity Disorder. The Go/No-Go Task is a neuropsychological test that provides a direct measure of number of responses made that are "correct" or "incorrect". It is not a scale. Reported are the percentage of correct responses on that direct performance measure. 0% correct is worse than 100% correct.
Primary	fMRI Reaction Time	up to 6 weeks	Reaction-time, as measured by the reaction time test Go/No-Go Task as a Function of Trial Type, Face Emotion, and Drug Condition in Adults with Attention-Deficit/Hyperactivity Disorder
Secondary	BRIEF-A	Baseline	Behavior Rating Inventory of Executive Function®-Adult Version (BRIEF-A): Norm Referenced Measure of Impaired Executive Functioning, reported in T-Scores (0 to 100, with 50 +/-1 SD = 'Normal', higher is worse, more impaired)
Secondary	BRIEF-A	at one week	Behavior Rating Inventory of Executive Function®-Adult Version (BRIEF-A): Norm Referenced Measure of Impaired Executive Functioning, reported in T-Scores (higher is worse)
Secondary	BRIEF-A	at 4 weeks	Behavior Rating Inventory of Executive Function®-Adult Version (BRIEF-A): Norm Referenced Measure of Impaired Executive Functioning, reported in T-Scores (higher is worse)
Secondary	ASRS - Expanded	Baseline	ADHD and Related Symptoms Measure (ASRS): self report, reported as Sum of Responses (0-4 per item, higher = more impaired) 0-26 (normal range) and \>27 (clinically significant symptoms).
Secondary	ASRS - Expanded	at one week	ADHD and Related Symptoms Measure (ASRS): self report, reported as Sum of Responses (0-4 per item, higher = more impaired) 0-26 (normal range) and \>27 (clinically significant symptoms).
Secondary	ASRS - Expanded	at 4 weeks	ADHD and Related Symptoms Measure (ASRS): self report, reported as Sum of Responses (0-4 per item, higher = more impaired) 0-26 (normal range) and \>27 (clinically significant symptoms).
Secondary	WRAADS	Baseline	The Wender-Reimherr adult attention deficit disorder scale (WRAADS): Symptom measure for emotional functioning/lability, generally reported as Sum of Responses (0-2 per item, higher = more impaired). For this outcome measure, Average scores for particular questions were taken - specifically question 3, question 4, and question 5.
Secondary	ADHD-RS-IV Combined Sum	Baseline	ADHD symptoms and severity. Norm referenced interview to assess severity and frequency of ADHD symptoms. 18 Items are scored 0-3 to reflect severity and frequency of ADHD symptoms, and a sum is taken. Full range from 0 to 54, with higher number indicating more symptoms and severity.

1 to 10 of 13Source ClinicalTrials.gov

See all 13 registered outcomes

Outcomes13

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	The Go/No-Go Task Percentage Assessed by fMRI	8 weeks	Performance measures are done while participants are off drug and while on drug.	percentage correct responses/inhibitions	MEAN
PRIMARY	fMRI Reaction Time	up to 6 weeks		ms	MEAN
SECONDARY	BRIEF-A	Baseline		t-score	MEAN
SECONDARY	BRIEF-A	at one week	not collected
SECONDARY	BRIEF-A	at 4 weeks	not collected
SECONDARY	ASRS - Expanded	Baseline		units on a scale	MEAN
SECONDARY	ASRS - Expanded	at one week	not collected
SECONDARY	ASRS - Expanded	at 4 weeks	not collected
SECONDARY	WRAADS	Baseline		units on a scale	MEAN
SECONDARY	ADHD-RS-IV Combined Sum	Baseline		units on a scale	MEAN

1 to 10 of 13Source ClinicalTrials.gov

See all 13 outcomes

Results by group40

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
The Go/No-Go Task Percentage Assessed by fMRI	Placebo	Happy Correct Responses	91.7	Standard Error 2.8	percentage correct responses/inhibitions
The Go/No-Go Task Percentage Assessed by fMRI	Lisdexamfetamine	Happy Correct Responses	97.0	Standard Error 3.8	percentage correct responses/inhibitions
The Go/No-Go Task Percentage Assessed by fMRI	Placebo	Happy Correct Inhibitions	88.7	Standard Error 9.4	percentage correct responses/inhibitions
The Go/No-Go Task Percentage Assessed by fMRI	Lisdexamfetamine	Happy Correct Inhibitions	87.9	Standard Error 11.5	percentage correct responses/inhibitions
The Go/No-Go Task Percentage Assessed by fMRI	Placebo	Sad Correct Responses	90.3	Standard Error 7.7	percentage correct responses/inhibitions
The Go/No-Go Task Percentage Assessed by fMRI	Lisdexamfetamine	Sad Correct Responses	88.5	Standard Error 10.6	percentage correct responses/inhibitions
The Go/No-Go Task Percentage Assessed by fMRI	Placebo	Sad Correct Inhibitions	84.4	Standard Error 12.5	percentage correct responses/inhibitions
The Go/No-Go Task Percentage Assessed by fMRI	Lisdexamfetamine	Sad Correct Inhibitions	86.7	Standard Error 11.3	percentage correct responses/inhibitions
The Go/No-Go Task Percentage Assessed by fMRI	Placebo	Neutral Correct Responses	93.2	Standard Error 12.2	percentage correct responses/inhibitions
The Go/No-Go Task Percentage Assessed by fMRI	Lisdexamfetamine	Neutral Correct Responses	95.6	Standard Error 5.8	percentage correct responses/inhibitions

1 to 10 of 40Source ClinicalTrials.gov

See all 40 results by group

Participant flow18

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Period 1 - First Intervention (4 Weeks)	STARTED	On Drug Then Off Drug	17
Period 1 - First Intervention (4 Weeks)	STARTED	Off Drug Then on Drug	13
Period 1 - First Intervention (4 Weeks)	COMPLETED	On Drug Then Off Drug	17
Period 1 - First Intervention (4 Weeks)	COMPLETED	Off Drug Then on Drug	13
Period 1 - First Intervention (4 Weeks)	NOT COMPLETED	On Drug Then Off Drug	0
Period 1 - First Intervention (4 Weeks)	NOT COMPLETED	Off Drug Then on Drug	0
Washout Period (2 Weeks)	STARTED	On Drug Then Off Drug	17
Washout Period (2 Weeks)	STARTED	Off Drug Then on Drug	13
Washout Period (2 Weeks)	COMPLETED	On Drug Then Off Drug	14
Washout Period (2 Weeks)	COMPLETED	Off Drug Then on Drug	11

1 to 10 of 18Source ClinicalTrials.gov

See all 18 participant flow

Adverse events34

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Incidental finding on brain scan	General disorders	On Drug, Then Off Drug	0	14
other	Incidental finding on brain scan	General disorders	Off Drug, Then on Drug	1	11
other	Incidental Physical finding	General disorders	On Drug, Then Off Drug	3	14
other	Incidental Physical finding	General disorders	Off Drug, Then on Drug	0	11
other	Insomnia	General disorders	On Drug, Then Off Drug	2	14
other	Insomnia	General disorders	Off Drug, Then on Drug	1	11
other	Heart Racing	General disorders	On Drug, Then Off Drug	1	14
other	Heart Racing	General disorders	Off Drug, Then on Drug	0	11
other	Dry mouth	General disorders	On Drug, Then Off Drug	1	14
other	Dry mouth	General disorders	Off Drug, Then on Drug	2	11

1 to 10 of 34Source ClinicalTrials.gov

See all 34 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	On Drug, Then Off Drug	0	14
Total, all-cause mortality	Off Drug, Then on Drug	0	11
Total, other adverse events	On Drug, Then Off Drug	14	14
Total, other adverse events	Off Drug, Then on Drug	11	11
Total, serious adverse events	On Drug, Then Off Drug	0	14
Total, serious adverse events	Off Drug, Then on Drug	0	11

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
29661516	DERIVED	PubMed
38101205	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
On Drug, Then Off Drug vs Off Drug, Then on Drug: deaths from any cause	Trial comparisons
On Drug, Then Off Drug vs Off Drug, Then on Drug: serious adverse events	Trial comparisons

Tests1

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

Test	Named as
Go/No-Go Task	Primary outcome

Source ConductCognition

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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