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Effortful control refers to the mental processes that help a person to regulate his or her own attention, thoughts, and emotions. This study will examine behavioral differences in healthy individuals when performing a task that induces fatigue.
The purpose of this study is to examine the effects of methylphenidate on the cognitive functions in healthy individuals when performing fatiguing cognitive tasks.
Based on the multi-source interference task, all subjects' cognitive functions will be assessed based on reaction time, reaction variability, and accuracy of performance on the attention control task.
This study aims to recruit 120 total healthy participants. Overall Safety Plan Subject Protections and Safety Monitoring
i. Data Safety and Monitoring Plan
ii. Reporting of adverse events
Adverse events (AEs) will be recorded and tracked for these projects. Adverse events will be reported per IRBs, FDA, and NIH guidelines. An adverse event is any experience that has taken place during the course of a research project, which, in the opinion of the investigators, was harmful to a subject participating in the research, increased the risks of harm in the research, or had an unfavorable impact on the risk/benefit ratio. Adverse events will be graded using the mild, moderate, severe terminology as defined:
The PI will assign attribution as definitely associated, probably associated, possibly associated, or unrelated. Adverse events will also be recorded as expected or unexpected. All Serious AEs and/or unexpected AEs will be reported to the IRB, NIH, and the FDA, within 7 days of occurrence or recognition. Fatal or life-threatening adverse events will be reported to the above institutions within 24 hours. Regular annual reviews of protocol activity and all adverse events will be submitted to the IRBs and NIH. Other less serious and expected AEs will also be reported to the above institutions with compliance to their requirements.
iii. Persons responsible Chandra Sekhar Sripada and Project Coordinator Christina Bohensky will be responsible for overseeing data integrity, safety monitoring, and reporting of adverse events. During the phone conferences and semi -annual meetings adverse events, recruitment, data quality and integrity and compliance with protocols will be discussed as well.
VI. Data Analysis Regression analysis will be utilized to assess whether the dependent measures for the tasks (accuracy, reaction time) are significantly correlated with measures of trait impulsivity derived from the Barratt Impulsivity Scale-11 questionnaire. Independent samples t-tests will be used to determine whether task performance differs due to methylphenidate versus placebo administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo Easy | Other | Healthy participant to be given 20 mgs of a placebo one hour before task performance and will perform an easy task. |
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| Placebo Hard | Other | Healthy participants are given 20 mgs of placebo one hour before task performance and will perform a hard task. |
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| Methylphenidate Easy | Other | Healthy participants are given 20 mgs of methylphenidate one hour before task performance and will perform an easy task. |
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| Methylphenidate Hard | Other | Healthy participants are given 20 mgs of methylphenidate one hour before task performance and will perform a hard task. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methylphenidate | Drug | 20 mgs of methylphenidate or placebo to be administered one hour before task performance |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reaction Time on the Multi-Source Interference Task | Reaction time on the Multi-Source Interference Task is measured in milliseconds. Participants were given 200 trials and their mean reaction time was calculated. | 20-30 minutes for task completion |
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy on the Multi-Source Interference Task. | Patients completed 200 trials and the percentage of answers correct was calculated. | 20-30 minutes |
| Reaction Time Variability on the Multi-Source Interference Task. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chandra Sekhar Sripada, MD, PhD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rachel Upjohn Building, East Medical Campus | Ann Arbor | Michigan | 48109-2700 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo Easy | Healthy participants are given a placebo (sugar pill) one hour before task performance and complete an easy version of the Letter E task. |
| FG001 | Placebo Hard | Healthy participants are given a placebo (sugar pill) one hour before task performance and complete a hard version of the Letter E task. |
| FG002 | Methylphenidate Easy | Participants are given 20 mgs of methylphenidate one hour before task performance and complete an easy version of the Letter E task. |
| FG003 | Methylphenidate Hard | Healthy participants are given 20 mgs of methylphenidate one hour before task performance and complete a hard version of the Letter E task. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo Easy | Healthy participants are given a placebo (sugar pill) one hour before task performance and complete an easy version of the Letter E task. |
| BG001 | Placebo Hard | Healthy participants are given 20 mgs of Methylphenidate one hour before task performance and complete a hard version of the Letter E task. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Participants who had more than 20% error on the Letter E task were excluded from analysis. |
| 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 | Reaction Time on the Multi-Source Interference Task | Reaction time on the Multi-Source Interference Task is measured in milliseconds. Participants were given 200 trials and their mean reaction time was calculated. | Participants whose accuracy on task one fell below 80% or who were greater than two standard deviation outliers in reaction time were excluded from analysis. | Posted | Mean | Standard Deviation | milliseconds | 20-30 minutes for task completion |
|
2 hours
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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 Easy | Healthy participants are given a placebo (sugar pill) one hour before task performance and complete an easy version of the Letter E task. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Chandra Sripada, MD PhD | University of Michigan | csripada@umich.edu |
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| ID | Term |
|---|---|
| D008774 | Methylphenidate |
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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|
| Placebo | Drug | 20 mgs of methylphenidate or a placebo to be administered one hour before task performance |
|
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| Easy Behavioral Task | Behavioral | Subjects do an easy version of the Letter E Task. |
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| Hard Behavioral Task | Behavioral | Subjects do a hard version of the Letter E Task. |
|
Reaction time variability on the Multi-Source Interference task is defined as the number of milliseconds between an individual's lowest and highest reaction time. This is averaged across all participants.
| 20-30 minutes |
| BG002 | Methylphenidate Easy | Healthy participants are given 20 mgs of Methylphenidate one hour before task performance and complete an easy version of the Letter E task. |
| BG003 | Methylphenidate Hard | Healthy participants are given 20 mgs of Methylphenidate one hour before task performance and complete a hard version of the Letter E task. |
| BG004 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Age, Continuous | Participants with greater than 20% error on the Letter E task were excluded from analysis. | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Participants who had greater than 20% error on the Letter E task were excluded from analysis. | Count of Participants | Participants |
|
| Region of Enrollment | Participants with greater than 20% error on the Letter E task were excluded from analysis. | Count of Participants | Participants |
|
Healthy participants are given a placebo (sugar pill) one hour before task performance and complete a hard version of the Letter E task.
| OG002 | Methylphenidate Easy | Healthy participants are given 20 mgs of Methylphenidate one hour before task performance and complete an easy version of the Letter E task. |
| OG003 | Methylphenidate Hard | Healthy participants are given 20 mgs of Methylphenidate one hour before task performance and complete a hard version of the Letter E task. |
|
|
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| Secondary | Accuracy on the Multi-Source Interference Task. | Patients completed 200 trials and the percentage of answers correct was calculated. | Participants whose accuracy on task one fell below 80% or who were greater than two standard deviation outliers in reaction time were excluded from analysis. | Posted | Mean | Standard Deviation | percentage of answers which were correct | 20-30 minutes |
|
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|
|
| Secondary | Reaction Time Variability on the Multi-Source Interference Task. | Reaction time variability on the Multi-Source Interference task is defined as the number of milliseconds between an individual's lowest and highest reaction time. This is averaged across all participants. | Participants whose accuracy on task one fell below 80% or who were greater than two standard deviation outliers in reaction time were excluded from analysis. | Posted | Mean | Standard Deviation | milliseconds | 20-30 minutes |
|
|
|
|
| 0 |
| 27 |
| 0 |
| 27 |
| 0 |
| 27 |
| EG001 | Placebo Hard | Healthy participants are given a placebo (sugar pill) one hour before task performance and complete a hard version of the Letter E task. | 0 | 27 | 0 | 27 | 0 | 27 |
| EG002 | Methylphenidate Easy | Healthy participants are given 20 mgs of Methylphenidate one hour before task performance and complete an easy version of the Letter E task. | 0 | 27 | 0 | 27 | 0 | 27 |
| EG003 | Methylphenidate Hard | Healthy participants are given 20 mgs of Methylphenidate one hour before task performance and complete a hard version of the Letter E task. | 0 | 27 | 0 | 27 | 0 | 27 |
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| D010880 |
| Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D002241 | Carbohydrates |
| Between 18 and 65 years |
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| >=65 years |
|
| Male |
|