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| ID | Type | Description | Link |
|---|---|---|---|
| Pro00068353 | Other Identifier | Duke University |
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To investigate the effects of methylphenidate on motivated behavior in adults with and without ADHD
This study has a mixed between- and within-subject design. Participants are young adults (aged 18-45) with ADHD and non-ADHD matched controls. They will be recruited from locations around the community, consented, screened for eligibility, then scheduled for 2 study days. Study days will be at least 48 hours apart. Thus, there will be a total of 3 lab visits across a 3 week period. Participants will be administered study drug on one study day and placebo on the other study day. They will complete a battery of cognitive/behavioral tasks and answer questionnaires on both study days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ADHD group | Experimental | Adults with ADHD |
|
| non-ADHD group | Experimental | Adults without ADHD |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ADHD methylphenidate first, placebo second | Drug | double-blind, counter-balanced administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of High-effort Selections in the Effort-based Decision Making Task | Number of high-effort selections in the effort-based decision making task from the placebo to the methylphenidate condition. This is a decision-making task where participants make high- or low-effort choices to earn a small financial reward. High-effort selections require 100 button presses with non-dominant hand pinky finger and low-effort selections require 30 button presses with dominant hand index finger (within 15 seconds). The number of high effort selections are summed across 50 trials of the task. This task measures the willingness to perform effort in relation to changing reward magnitude and probability. This is a basic science experiment, the clinical and/or physiological relevance of these results are not established. | 1 hour post drug (or placebo) administration for each study session |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Merideth A Addicott, PhD | University of Arkansas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72205 | United States | ||
| Duke University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31226260 | Derived | Addicott MA, Schechter JC, Sapyta JJ, Selig JP, Kollins SH, Weiss MD. Methylphenidate increases willingness to perform effort in adults with ADHD. Pharmacol Biochem Behav. 2019 Aug;183:14-21. doi: 10.1016/j.pbb.2019.06.008. Epub 2019 Jun 18. |
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Within each study arm (ADHD or non-ADHD subjects), subjects were exposed to placebo and drug (each at a different timepoint in the study). Approximately half of the subjects within each arm received drug first and half received placebo first (i.e., order was counterbalanced).
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| ID | Title | Description |
|---|---|---|
| FG000 | ADHD Methylphenidate First, Placebo Second | Adults with ADHD who received drug (methylphenidate) first, followed by placebo |
| FG001 | ADHD Placebo First, Methylphenidate Second | Adults with ADHD who received placebo first, followed by drug (methylphenidate) |
| FG002 | Non-ADHD Methylphenidate First, Placebo Second | Adults without ADHD who received drug (methylphenidate) first, followed by placebo |
| FG003 | Non-ADHD Placebo First, Methylphenidate Second | Adults without ADHD who received placebo first, followed by drug (methylphenidate) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ADHD | Adults with ADHD |
| BG001 | Non-ADHD | Adults without ADHD |
| BG002 |
| 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 | Number of High-effort Selections in the Effort-based Decision Making Task | Number of high-effort selections in the effort-based decision making task from the placebo to the methylphenidate condition. This is a decision-making task where participants make high- or low-effort choices to earn a small financial reward. High-effort selections require 100 button presses with non-dominant hand pinky finger and low-effort selections require 30 button presses with dominant hand index finger (within 15 seconds). The number of high effort selections are summed across 50 trials of the task. This task measures the willingness to perform effort in relation to changing reward magnitude and probability. This is a basic science experiment, the clinical and/or physiological relevance of these results are not established. | Approximately half of the subjects within each arm (ADHD or non-ADHD) received drug first and half received placebo first (i.e., order was counterbalanced). The study was powered to compare two groups (ADHD vs non-ADHD). Since order of drug was counterbalanced, this means all ADHD subjects were evaluated under both placebo and drug conditions, and this is also true for the non-ADHD subjects. | Posted | Mean | Standard Error | Number of high-effort selections | 1 hour post drug (or placebo) administration for each study session |
For each individual participant, 3 weeks (up to 60 days maximum)
Data are being reporting according to the participant flow for the study.
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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 | ADHD Methylphenidate First, Placebo Second | Adults with ADHD who received drug (methylphenidate) first, followed by placebo |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Merideth Addicott | University of Arkansas for Medical Sciences | 501-526-8436 | maddicott@uams.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 6, 2018 | Apr 20, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 13, 2019 | Apr 20, 2021 | SAP_001.pdf |
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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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There are two parallel arms of this study (ADHD or non-ADHD subjects).
Within each arm, each subject will be exposed to placebo and a drug (each at a different timepoint in the study). Although all subjects will receive both placebo and the drug, the order of presentation of the placebo and drug is counterbalanced across subjects (i.e., approximately half will receive the drug first and approximately half will receive the placebo first).
For both study arms, regardless of whether the placebo is received first or second, the outcome measure will be calculated as the number of high effort selections.
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| ADHD placebo first, methylphenidate second | Drug | double-blind, counter-balanced administration |
|
| Non-ADHD methylphenidate first, placebo second | Drug | double-blind, counter-balanced administration |
|
| Non-ADHD placebo first, methylphenidate second | Drug |
|
| Durham |
| North Carolina |
| 27705 |
| United States |
| Total |
Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | ADHD Subjects, Placebo Condition | Adults with ADHD, under the placebo condition |
| OG001 | ADHD Subjects, Methylphenidate Condition | Adults with ADHD, under the methylphenidate (drug) condition |
| OG002 | Non-ADHD Subjects, Placebo Condition | Adults without ADHD, under the placebo condition |
| OG003 | Non-ADHD Subjects, Methylphenidate Condition | Adults without ADHD, under the methylphenidate (drug) condition |
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | ADHD Placebo First, Methylphenidate Second | Adults with ADHD who received placebo first, followed by drug (methylphenidate) | 0 | 11 | 0 | 11 | 0 | 11 |
| EG002 | Non-ADHD Methylphenidate First, Placebo Second | Adults without ADHD who received drug (methylphenidate) first, followed by placebo | 0 | 11 | 0 | 11 | 0 | 11 |
| EG003 | Non-ADHD Placebo First, Methylphenidate Second | Adults without ADHD who received placebo first, followed by drug (methylphenidate) | 0 | 12 | 0 | 12 | 0 | 12 |
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