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Trial record 14 of 110 for:    nrp 104 OR lisdexamfetamine

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

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ClinicalTrials.gov Identifier: NCT01924429
Recruitment Status : Completed
First Posted : August 16, 2013
Results First Posted : June 6, 2018
Last Update Posted : June 6, 2018
Sponsor:
Information provided by (Responsible Party):
Jeffrey Newcorn, Icahn School of Medicine at Mount Sinai

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Single (Participant);   Primary Purpose: Basic Science
Condition ADHD
Intervention Drug: Lisdexamfetamine
Enrollment 30
Recruitment Details  
Pre-assignment Details  
Arm/Group Title On Drug Then Off Drug Off Drug Then on Drug
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Participants receive fMRI #1 on drug, #2 off drug Escalating stepped titration: 30, 50 or 70mg

Lisdexamphetamine: Escalating stepped dose titration: 30, 50 or 70mg

Participants receive fMRI #1 off drug, #2 on drug Escalating stepped dose titration: 30, 50, 70mg

Lisdexamphetamine: Escalating stepped dose titration: 30, 50 or 70mg

Period Title: Period 1 - First Intervention (4 Weeks)
Started 17 13
Completed 17 13
Not Completed 0 0
Period Title: Washout Period (2 Weeks)
Started 17 13
Completed 14 11
Not Completed 3 2
Reason Not Completed
Withdrawal by Subject             3             2
Period Title: Period 2 - Second Intervention (4 Weeks)
Started 14 11
Completed 14 11
Not Completed 0 0
Arm/Group Title On Drug, Then Off Drug Off Drug, Then on Drug Total
Hide Arm/Group Description fMRI #1 on drug, #2 off drug fMRI #1 off drug, #2 on drug Total of all reporting groups
Overall Number of Baseline Participants 17 13 30
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[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 17 participants 13 participants 30 participants
35.46  (11.82) 37.27  (11.81) 35.84  (10.25)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 13 participants 30 participants
Female
8
  47.1%
5
  38.5%
13
  43.3%
Male
9
  52.9%
8
  61.5%
17
  56.7%
1.Primary Outcome
Title The Go/No-Go Task Percentage Assessed by fMRI
Hide Description 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.
Time Frame 8 weeks
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Performance measures are done while participants are off drug and while on drug.
Arm/Group Title Placebo Lisdexamfetamine
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Participants received fMRI while off drug
Participants received fMRI while on drug
Overall Number of Participants Analyzed 25 25
Mean (Standard Error)
Unit of Measure: percentage correct responses/inhibitions
Happy Correct Responses 91.7  (2.8) 97.0  (3.8)
Happy Correct Inhibitions 88.7  (9.4) 87.9  (11.5)
Sad Correct Responses 90.3  (7.7) 88.5  (10.6)
Sad Correct Inhibitions 84.4  (12.5) 86.7  (11.3)
Neutral Correct Responses 93.2  (12.2) 95.6  (5.8)
Neutral Correct Inhibitions 77.5  (12.3) 79.6  (11.6)
2.Primary Outcome
Title fMRI Reaction Time
Hide Description 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
Time Frame up to 6 weeks
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[Not Specified]
Arm/Group Title Placebo Lisdexamfetamine
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Participants received fMRI while off drug
Participants received fMRI while on drug
Overall Number of Participants Analyzed 25 25
Mean (Standard Error)
Unit of Measure: ms
Happy 532  (99) 519  (114)
Sad 533  (110) 509  (96)
Neutral 553  (109) 533  (104)
3.Secondary Outcome
Title BRIEF-A
Hide Description 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)
Time Frame Baseline
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title On Drug Then Off Drug Off Drug Then on Drug
Hide Arm/Group Description:

Participants receive fMRI #1 on drug, #2 off drug Escalating stepped titration: 30, 50 or 70mg

Lisdexamphetamine: Escalating stepped dose titration: 30, 50 or 70mg

Participants receive fMRI #1 off drug, #2 on drug Escalating stepped dose titration: 30, 50, 70mg

Lisdexamphetamine: Escalating stepped dose titration: 30, 50 or 70mg

Overall Number of Participants Analyzed 14 11
Mean (Standard Deviation)
Unit of Measure: t-score
66.64  (11.89) 73.5  (14.75)
4.Secondary Outcome
Title BRIEF-A
Hide Description Behavior Rating Inventory of Executive Function®–Adult Version (BRIEF-A): Norm Referenced Measure of Impaired Executive Functioning, reported in T-Scores (higher is worse)
Time Frame at one week
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Hide Analysis Population Description
not collected
Arm/Group Title On Drug Then Off Drug Off Drug Then on Drug
Hide Arm/Group Description:

Participants receive fMRI #1 on drug, #2 off drug Escalating stepped titration: 30, 50 or 70mg

Lisdexamphetamine: Escalating stepped dose titration: 30, 50 or 70mg

Participants receive fMRI #1 off drug, #2 on drug Escalating stepped dose titration: 30, 50, 70mg

Lisdexamphetamine: Escalating stepped dose titration: 30, 50 or 70mg

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title BRIEF-A
Hide Description Behavior Rating Inventory of Executive Function®–Adult Version (BRIEF-A): Norm Referenced Measure of Impaired Executive Functioning, reported in T-Scores (higher is worse)
Time Frame at 4 weeks
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Hide Analysis Population Description
not collected
Arm/Group Title On Drug Then Off Drug Off Drug Then on Drug
Hide Arm/Group Description:

Participants receive fMRI #1 on drug, #2 off drug Escalating stepped titration: 30, 50 or 70mg

Lisdexamphetamine: Escalating stepped dose titration: 30, 50 or 70mg

Participants receive fMRI #1 off drug, #2 on drug Escalating stepped dose titration: 30, 50, 70mg

Lisdexamphetamine: Escalating stepped dose titration: 30, 50 or 70mg

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title ASRS - Expanded
Hide Description 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).
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title On Drug Then Off Drug Off Drug Then on Drug
Hide Arm/Group Description:

Participants receive fMRI #1 on drug, #2 off drug Escalating stepped titration: 30, 50 or 70mg

Lisdexamphetamine: Escalating stepped dose titration: 30, 50 or 70mg

Participants receive fMRI #1 off drug, #2 on drug Escalating stepped dose titration: 30, 50, 70mg

Lisdexamphetamine: Escalating stepped dose titration: 30, 50 or 70mg

Overall Number of Participants Analyzed 14 11
Mean (Standard Deviation)
Unit of Measure: units on a scale
83.7  (25.59) 86  (4.24)
7.Secondary Outcome
Title ASRS - Expanded
Hide Description 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).
Time Frame at one week
Hide Outcome Measure Data
Hide Analysis Population Description
not collected
Arm/Group Title On Drug Then Off Drug Off Drug Then on Drug
Hide Arm/Group Description:

Participants receive fMRI #1 on drug, #2 off drug Escalating stepped titration: 30, 50 or 70mg

Lisdexamphetamine: Escalating stepped dose titration: 30, 50 or 70mg

Participants receive fMRI #1 off drug, #2 on drug Escalating stepped dose titration: 30, 50, 70mg

Lisdexamphetamine: Escalating stepped dose titration: 30, 50 or 70mg

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title ASRS - Expanded
Hide Description 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).
Time Frame at 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
not collected
Arm/Group Title On Drug Then Off Drug Off Drug Then on Drug
Hide Arm/Group Description:

Participants receive fMRI #1 on drug, #2 off drug Escalating stepped titration: 30, 50 or 70mg

Lisdexamphetamine: Escalating stepped dose titration: 30, 50 or 70mg

Participants receive fMRI #1 off drug, #2 on drug Escalating stepped dose titration: 30, 50, 70mg

Lisdexamphetamine: Escalating stepped dose titration: 30, 50 or 70mg

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
9.Secondary Outcome
Title WRAADS
Hide Description

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.

Time Frame Baseline
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title On Drug Then Off Drug Off Drug Then on Drug
Hide Arm/Group Description:

Participants receive fMRI #1 on drug, #2 off drug Escalating stepped titration: 30, 50 or 70mg

Lisdexamphetamine: Escalating stepped dose titration: 30, 50 or 70mg

Participants receive fMRI #1 off drug, #2 on drug Escalating stepped dose titration: 30, 50, 70mg

Lisdexamphetamine: Escalating stepped dose titration: 30, 50 or 70mg

Overall Number of Participants Analyzed 14 11
Mean (Standard Deviation)
Unit of Measure: units on a scale
Question 3 0.80  (0.86) 0.94  (0.745)
Question 4 1.27  (1.22) 1.47  (1.23)
Question 5 1.13  (1.35) 1.82  (1.19)
10.Secondary Outcome
Title ADHD-RS-IV Combined Sum
Hide Description 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.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title On Drug Then Off Drug Off Drug Then on Drug
Hide Arm/Group Description:

Participants receive fMRI #1 on drug, #2 off drug Escalating stepped titration: 30, 50 or 70mg

Lisdexamphetamine: Escalating stepped dose titration: 30, 50 or 70mg

Participants receive fMRI #1 off drug, #2 on drug Escalating stepped dose titration: 30, 50, 70mg

Lisdexamphetamine: Escalating stepped dose titration: 30, 50 or 70mg

Overall Number of Participants Analyzed 14 11
Mean (Standard Deviation)
Unit of Measure: units on a scale
On Drug 11.00  (6.98) 13.67  (11.64)
Placebo 25.65  (8.53) 31.00  (14.80)
11.Secondary Outcome
Title ADHD-Inattentive
Hide Description ADHD symptoms and severity - subscale for Inattentiveness. 9-item scale, each scored 0-3, with total from 0 to 27. Higher score indicates higher level of inattentiveness.
Time Frame 4 weeks and 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title On Drug Then Off Drug Off Drug Then on Drug
Hide Arm/Group Description:

Participants receive fMRI #1 on drug, #2 off drug Escalating stepped titration: 30, 50 or 70mg

Lisdexamphetamine: Escalating stepped dose titration: 30, 50 or 70mg

Participants receive fMRI #1 off drug, #2 on drug Escalating stepped dose titration: 30, 50, 70mg

Lisdexamphetamine: Escalating stepped dose titration: 30, 50 or 70mg

Overall Number of Participants Analyzed 14 11
Mean (Standard Deviation)
Unit of Measure: units on a scale
On drug 7.36  (4.53) 8.83  (7.63)
Placebo 18.94  (6.21) 19.2  (5.07)
12.Secondary Outcome
Title CGI-I
Hide Description Clinical Global Impressions – CGI-I: Clinical response was the Clinical Global Impression-Improvement scale (CGI-I). Lower CGI-I scores indicate greater improvement (1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse).
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title On Drug Then Off Drug Off Drug Then on Drug
Hide Arm/Group Description:

Participants receive fMRI #1 on drug, #2 off drug Escalating stepped titration: 30, 50 or 70mg

Lisdexamphetamine: Escalating stepped dose titration: 30, 50 or 70mg

Participants receive fMRI #1 off drug, #2 on drug Escalating stepped dose titration: 30, 50, 70mg

Lisdexamphetamine: Escalating stepped dose titration: 30, 50 or 70mg

Overall Number of Participants Analyzed 14 11
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.88  (1.13) 2.00  (1.41)
13.Secondary Outcome
Title CGI-S
Hide Description CGI-S: Severity of impairment due to ADHD was measured by the Clinical Global Impressions-Severity scale (CGI-S). Lower scores indicate less severe impairment from symptoms, with a CGI-I=1 indicating the person is “normal” with no impairment. (1= normal, not ill, 2= minimally ill, 3= mildly ill, 4= moderately ill, 5=markedly ill, 6=severely ill, 7= very severely ill)
Time Frame baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title On Drug Then Off Drug Off Drug Then on Drug
Hide Arm/Group Description:

Participants receive fMRI #1 on drug, #2 off drug Escalating stepped titration: 30, 50 or 70mg

Lisdexamphetamine: Escalating stepped dose titration: 30, 50 or 70mg

Participants receive fMRI #1 off drug, #2 on drug Escalating stepped dose titration: 30, 50, 70mg

Lisdexamphetamine: Escalating stepped dose titration: 30, 50 or 70mg

Overall Number of Participants Analyzed 14 11
Mean (Standard Deviation)
Unit of Measure: units on a scale
4.9  (1.0) 4.95  (0.9)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title On Drug, Then Off Drug Off Drug, Then on Drug
Hide Arm/Group Description

Participants receive fMRI #1 on drug, #2 off drug Escalating stepped titration: 30, 50 or 70mg

Lisdexamphetamine: Escalating stepped dose titration: 30, 50 or 70mg

Participants receive fMRI #1 off drug, #2 on drug Escalating stepped dose titration: 30, 50, 70mg

Lisdexamphetamine: Escalating stepped dose titration: 30, 50 or 70mg

All-Cause Mortality
On Drug, Then Off Drug Off Drug, Then on Drug
Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)   0/11 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
On Drug, Then Off Drug Off Drug, Then on Drug
Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)   0/11 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
On Drug, Then Off Drug Off Drug, Then on Drug
Affected / at Risk (%) Affected / at Risk (%)
Total   14/14 (100.00%)   11/11 (100.00%) 
General disorders     
Incidental finding on brain scan [1]  0/14 (0.00%)  1/11 (9.09%) 
Incidental Physical finding [1]  3/14 (21.43%)  0/11 (0.00%) 
Insomnia  2/14 (14.29%)  1/11 (9.09%) 
Heart Racing [2]  1/14 (7.14%)  0/11 (0.00%) 
Dry mouth  1/14 (7.14%)  2/11 (18.18%) 
feeling agitated [3]  1/14 (7.14%)  0/11 (0.00%) 
Tired  1/14 (7.14%)  0/11 (0.00%) 
Anxious  1/14 (7.14%)  2/11 (18.18%) 
Headache  1/14 (7.14%)  2/11 (18.18%) 
Restless  1/14 (7.14%)  0/11 (0.00%) 
Seasonal allergies  0/14 (0.00%)  2/11 (18.18%) 
Subjectively feeling "stuck" [4]  0/14 (0.00%)  1/11 (9.09%) 
Suspiciousness  1/14 (7.14%)  0/11 (0.00%) 
Reduced Appetite  1/14 (7.14%)  0/11 (0.00%) 
Bruxism  0/14 (0.00%)  1/11 (9.09%) 
Musculoskeletal and connective tissue disorders     
Backache  1/14 (7.14%)  0/11 (0.00%) 
Skin and subcutaneous tissue disorders     
Skin Sores  1/14 (7.14%)  0/11 (0.00%) 
[1]
benign
[2]
secondary to anxiety
[3]
counseled to reduce caffeine
[4]
no motivation
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Jeffrey Newcorn
Organization: Icahn School of Medicine at Mount Sinai
Phone: 212-659-8775
EMail: Jeffrey.newcorn@mssm.edu
Layout table for additonal information
Responsible Party: Jeffrey Newcorn, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT01924429     History of Changes
Other Study ID Numbers: GCO 09-1186
First Submitted: August 14, 2013
First Posted: August 16, 2013
Results First Submitted: March 27, 2017
Results First Posted: June 6, 2018
Last Update Posted: June 6, 2018