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| Name | Class |
|---|---|
| Lehigh University | OTHER |
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The purpose of this study was to evaluate the effects of lisdexamfetamine dimesylate, a prodrug stimulant, on the behavioral, academic, and psychosocial functioning of college students with attention-deficit/hyperactivity disorder (ADHD). Twenty-five college students with ADHD from two universities (University of Rhode Island and Lehigh University) completed a within-subject, placebo-controlled research trial. Dependent measures tapping behavioral, psychosocial, and academic functioning were completed on a weekly basis across five conditions (baseline, placebo, and 30-mg, 50-mg, and 70-mg lisdexamfetamine).
Objective: Evaluate stimulant medication on symptoms and functioning for college students with ADHD using double-blind, placebo-controlled, crossover design. Method: Participants included 24 college students with ADHD and 26 college students without psychopathology. Lisdexamfetamine dimesylate (LDX) examined for ADHD participants over five weekly phases (no-drug baseline, placebo, 30, 50, & 70-mg LDX per day). Self-report rating scales of functioning and direct assessment of ADHD symptoms, verbal learning/memory, and adverse side-effects were collected (baseline only for control students).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| lisdexamfetamine dimesylate | Experimental | All participants will be assessed across five conditions (baseline, placebo, 30-mg, 50-mg, & 70-mg) in a double-blind, crossover design |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lisdexamfetamine dimesylate | Drug | 30-mg, 50-mg, 70-mg administered for one week in context of double-blind, placebo-controlled crossover design |
|
| Measure | Description | Time Frame |
|---|---|---|
| Conners Adult ADHD Rating Scale - Short Version (CAARS) | CAARS ADHD Index, adult self-report measure of ADHD symptoms. T-scores (mean = 50; standard deviation = 10) for all subscales on the short version were used as dependent measures with higher scores representing greater ADHD symptomatology (and ultimately a worse outcome in this study). | after receiving Placebo or LDX for 1 week |
| Behavior Rating Inventory of Executive Function - Adult (BRIEF-A) | BRIEF-A is a standardized self-report measure that captures adults' views of their own self-regulation in their everyday environment. Metacognition Index T-scores (mean = 50; standard deviation = 10) were used as dependent measures with higher scores representing greater deficit in planning/organizational skills critical for college success. | after receiving Placebo or LDX for 1 week |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lisa L Weyandt, PhD | University of Rhode Island | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Education and Human Services, Lehigh University | Bethlehem | Pennsylvania | 18015 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22166471 | Result | Dupaul GJ, Weyandt LL, Rossi JS, Vilardo BA, O'Dell SM, Carson KM, Verdi G, Swentosky A. Double-blind, placebo-controlled, crossover study of the efficacy and safety of lisdexamfetamine dimesylate in college students with ADHD. J Atten Disord. 2012 Apr;16(3):202-20. doi: 10.1177/1087054711427299. Epub 2011 Dec 12. |
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Almost all participants completed all stages of the trial. One participant withdrew from the study after a possible adverse reaction.
Participants were recruited from student disabilities and health service offices at two univer- sities in the Northeastern United States (one public and one private).
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| ID | Title | Description |
|---|---|---|
| FG000 | Healthy Controls | All participants completed the Conners' Adult ADHD Rating Scales-Short Form (CAARS) and Behavior Rating Inventory of Executive Functioning-Adult Version (BRIEF) at baseline only and received no drug. |
| FG001 | Attention-deficit/Hyperactivity Disorder (ADHD) Participants | All participants completed the Conners' Adult ADHD Rating Scales-Short Form (CAARS) and Behavior Rating Inventory of Executive Functioning-Adult Version (BRIEF) at baseline and were randomly assigned to one of six medication orders using placebo, 30-mg, 50 and 70 mg lisdexamfetamine dimesylate (LDX) in the context of a double-blind, crossover design, with repeated measures at the end of each drug phase. Phase orders (following baseline) were assigned in a counterbalanced fashion across participants. To avoid starting any participant with the highest dosage, the 50-mg condition always preceded the 70-mg condition. Each phase was conducted for 1 week, and therefore, the total trial took place over 5 weeks and was able to be completed during a single semester. Participants ingested one pill per day on awakening. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ADHD Participants | All participants completed the Conners' Adult ADHD Rating Scales-Short Form (CAARS) and Behavior Rating Inventory of Executive Functioning-Adult Version (BRIEF) at baseline and were randomly assigned to one of six medication orders using placebo, 30-mg, 50 and 70 mg LDX in the context of a double-blind, crossover design, with repeated measures at the end of each drug phase. Phase orders (following baseline) were assigned in a counterbalanced fashion across participants. To avoid starting any participant with the highest dosage, the 50-mg condition always preceded the 70-mg condition. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Conners Adult ADHD Rating Scale - Short Version (CAARS) | CAARS ADHD Index, adult self-report measure of ADHD symptoms. T-scores (mean = 50; standard deviation = 10) for all subscales on the short version were used as dependent measures with higher scores representing greater ADHD symptomatology (and ultimately a worse outcome in this study). | Posted | Mean | Standard Deviation | T score | after receiving Placebo or LDX for 1 week |
|
Adverse event data was collected and updated on a daily basis during the 1 week receiving placebo or LDX.
If an adverse event occurred, the prescribing nurse would review with the participant and review risks. Adverse Events were only collected for the 24 participants who actually met inclusion criteria for ADHD and thus qualified for the medication trial
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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 | Placebo | All participants receiving Placebo for 1 week in a double-blind, crossover design |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Possible Heart Palpitations | Cardiac disorders | Other | Non-systematic Assessment | This was the adverse event for both participants. This occurred during week 1 of the medication trial in which both participants were taking an active dosage of 30mg. |
No notable limitations or caveats are noted.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Lisa Weyandt | University of Rhode Island | (401)874-2087 | lisaweyandt@uri.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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|
| Placebo | Drug |
|
| Department of Psychology, University of Rhode Island |
| Kingston |
| Rhode Island |
| 02881 |
| United States |
| BG001 | Healthy Controls | All participants completed the Conners' Adult ADHD Rating Scales-Short Form (CAARS) and Behavior Rating Inventory of Executive Functioning-Adult Version (BRIEF) at baseline only and received no drug. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Not all ethnicity categories are covered, and a participant may be counted in more than one ethnicity | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| Conners Adult Rating Scale | The Conners was converted to a T score with a mean of 50 and standard deviation of 10. Higher scores represent more severe ADHD symptoms. | Mean | Standard Deviation | T score |
|
| BRIEF | The BRIEF was converted to a T score with a mean of 50 and a standard deviation of 10. Higher scores represent poorer levels of functioning. | Mean | Standard Deviation | T score |
|
| Year in College | Number | participants |
|
| Father's level of education | Number | participants |
|
| Mother's level of education | Number | participants |
|
| OG002 | LDX 50-mg | All participants receiving 50-mg LDX for 1 week in a double-blind, crossover design |
| OG003 | LDX 70-mg | All participants receiving 70-mg LDX for 1 week in a double-blind, crossover design |
|
|
|
| Primary | Behavior Rating Inventory of Executive Function - Adult (BRIEF-A) | BRIEF-A is a standardized self-report measure that captures adults' views of their own self-regulation in their everyday environment. Metacognition Index T-scores (mean = 50; standard deviation = 10) were used as dependent measures with higher scores representing greater deficit in planning/organizational skills critical for college success. | Posted | Mean | Standard Deviation | T score | after receiving Placebo or LDX for 1 week |
|
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|
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| 0 |
| 24 |
| 0 |
| 24 |
| EG001 | LDX 30-mg | All participants receiving 30-mg LDX for 1 week in a double-blind, crossover design | 0 | 24 | 2 | 24 |
| EG002 | LDX 50-mg | All participants receiving 50-mg LDX for 1 week in a double-blind, crossover design | 0 | 24 | 0 | 24 |
| EG003 | LDX 70-mg | All participants receiving 70-mg LDX for 1 week in a double-blind, crossover design | 0 | 24 | 0 | 24 |
|
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| D005021 |
| Ethylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| Superiority or Other (legacy) |