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The purpose of this study is to determine the effects of Vyvanse, an FDA approved medication used in the treatment of Attention Deficit Hyperactivity Disorder (ADHD), on brain activity in adults with attention-deficit hyperactivity disorder (ADHD). Participants may qualify for participation in this study because they have ADHD and are willing to participate in two Functional Magnetic Resonance Imaging (fMRI) scans and receive Vyvanse for treatment of their symptoms. Another purpose of this study is to collect and bank samples of blood for research to examine how genes influence brain activation seen during the brain scans. The study also seeks to find out whether certain genes are related to ADHD. Participants' entire genetic makeup will not be determined from this sample.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| On Drug then off Drug | Experimental | Participants receive fMRI #1 on drug, #2 off drug Escalating stepped titration: 30, 50 or 70mg |
|
| Off drug then on drug | Experimental | Participants receive fMRI #1 off drug, #2 on drug Escalating stepped dose titration: 30, 50, 70mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lisdexamfetamine | Drug | Escalating stepped dose titration: 30, 50 or 70mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Go/No-Go Task Percentage Assessed by fMRI | 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. | 8 weeks |
| fMRI Reaction Time | 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 | up to 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| BRIEF-A | 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) | Baseline |
| BRIEF-A |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey Newcorn, MD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38101205 | Derived | Newcorn JH, Ivanov I, Krone B, Li X, Duhoux S, White S, Schulz KP, Bedard AV, Pedraza J, Adler L, Blair RJ. Neurobiological basis of reinforcement-based decision making in adults with ADHD treated with lisdexamfetamine dimesylate: Preliminary findings and implications for mechanisms influencing clinical improvement. J Psychiatr Res. 2024 Feb;170:19-26. doi: 10.1016/j.jpsychires.2023.11.037. Epub 2023 Dec 3. | |
| 29661516 |
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| ID | Title | Description |
|---|---|---|
| FG000 | On Drug Then Off Drug | 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 |
| FG001 | Off Drug Then on Drug | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 - First Intervention (4 Weeks) |
| |||||||||||||
| Washout Period (2 Weeks) |
| |||||||||||||
| Period 2 - Second Intervention (4 Weeks) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | On Drug, Then Off Drug | fMRI #1 on drug, #2 off drug |
| BG001 | Off Drug, Then on Drug | fMRI #1 off drug, #2 on drug |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Go/No-Go Task Percentage Assessed by fMRI | 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. | Performance measures are done while participants are off drug and while on drug. | Posted | Mean | Standard Error | percentage correct responses/inhibitions | 8 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | On Drug, Then Off Drug | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Incidental finding on brain scan | General disorders | benign |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jeffrey Newcorn | Icahn School of Medicine at Mount Sinai | 212-659-8775 | Jeffrey.newcorn@mssm.edu |
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| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000069478 | Lisdexamfetamine Dimesylate |
| ID | Term |
|---|---|
| D003913 | Dextroamphetamine |
| D000661 | Amphetamine |
| D000662 | Amphetamines |
| D010627 | Phenethylamines |
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Behavior Rating Inventory of Executive Function®-Adult Version (BRIEF-A): Norm Referenced Measure of Impaired Executive Functioning, reported in T-Scores (higher is worse) |
| at one week |
| BRIEF-A | Behavior Rating Inventory of Executive Function®-Adult Version (BRIEF-A): Norm Referenced Measure of Impaired Executive Functioning, reported in T-Scores (higher is worse) | at 4 weeks |
| ASRS - Expanded | 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). | Baseline |
| ASRS - Expanded | 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). | at one week |
| ASRS - Expanded | 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). | at 4 weeks |
| WRAADS | 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. | Baseline |
| ADHD-RS-IV Combined Sum | 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. | Baseline |
| ADHD-Inattentive | 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. | 4 weeks and 8 weeks |
| CGI-I | 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). | Baseline |
| CGI-S | 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) | baseline |
| Derived |
| Schulz KP, Krone B, Adler LA, Bedard AV, Duhoux S, Pedraza J, Mahagabin S, Newcorn JH. Lisdexamfetamine Targets Amygdala Mechanisms That Bias Cognitive Control in Attention-Deficit/Hyperactivity Disorder. Biol Psychiatry Cogn Neurosci Neuroimaging. 2018 Aug;3(8):686-693. doi: 10.1016/j.bpsc.2018.03.004. Epub 2018 Mar 19. |
| NOT COMPLETED |
|
|
| NOT COMPLETED |
|
| BG002 |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Lisdexamfetamine |
Participants received fMRI while on drug |
|
|
| Primary | fMRI Reaction Time | 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 | Posted | Mean | Standard Error | ms | up to 6 weeks |
|
|
|
| Secondary | BRIEF-A | 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) | Posted | Mean | Standard Deviation | t-score | Baseline |
|
|
|
| Secondary | BRIEF-A | Behavior Rating Inventory of Executive Function®-Adult Version (BRIEF-A): Norm Referenced Measure of Impaired Executive Functioning, reported in T-Scores (higher is worse) | not collected | Posted | at one week |
|
|
| Secondary | BRIEF-A | Behavior Rating Inventory of Executive Function®-Adult Version (BRIEF-A): Norm Referenced Measure of Impaired Executive Functioning, reported in T-Scores (higher is worse) | not collected | Posted | at 4 weeks |
|
|
| Secondary | ASRS - Expanded | 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). | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
|
|
| Secondary | ASRS - Expanded | 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). | not collected | Posted | at one week |
|
|
| Secondary | ASRS - Expanded | 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). | not collected | Posted | at 4 weeks |
|
|
| Secondary | WRAADS | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
|
|
| Secondary | ADHD-RS-IV Combined Sum | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
|
|
| Secondary | ADHD-Inattentive | 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. | Posted | Mean | Standard Deviation | units on a scale | 4 weeks and 8 weeks |
|
|
|
| Secondary | CGI-I | 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). | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
|
|
| Secondary | CGI-S | 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) | Posted | Mean | Standard Deviation | units on a scale | baseline |
|
|
|
| 0 |
| 14 |
| 0 |
| 14 |
| 14 |
| 14 |
| EG001 | Off Drug, Then on Drug | 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 | 0 | 11 | 0 | 11 | 11 | 11 |
| Incidental Physical finding | General disorders | benign |
|
| Insomnia | General disorders |
|
| Heart Racing | General disorders | secondary to anxiety |
|
| Dry mouth | General disorders |
|
| feeling agitated | General disorders | counseled to reduce caffeine |
|
| Tired | General disorders |
|
| Anxious | General disorders |
|
| Headache | General disorders |
|
| Restless | General disorders |
|
| Seasonal allergies | General disorders |
|
| Subjectively feeling "stuck" | General disorders | no motivation |
|
| Suspiciousness | General disorders |
|
| Backache | Musculoskeletal and connective tissue disorders |
|
| Reduced Appetite | General disorders |
|
| Skin Sores | Skin and subcutaneous tissue disorders |
|
| Bruxism | General disorders |
|
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| D005021 |
| Ethylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| Neutral |
|
| Question 5 |
|