HealthyBDECNCT01852344
Behavioral Differences in Effortful Control
A study testing Methylphenidate, Easy Behavioral Task and Hard Behavioral Task in people with Healthy, run by University of Michigan at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Methylphenidate, Easy Behavioral Task and Hard Behavioral Task
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to 24 Apr 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age range 18-35
Who cannot join
- Pregnant or nursing (females)
- Any clinically significant medical condition
- Currently taking any medications (i.e., decongestants)
- Currently taking any psychoactive medications
- Alcohol or substance abuse (current or in the past 2 years)
- Liver or Kidney disease
- Any clinically significant personal or family history of cardiac problems
Trial locations and contacts
1 site in 1 country.
United States1 site
Rachel Upjohn Building, East Medical Campus
Ann Arbor, Michigan, 48109-2700
About this study
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.
Read the detailed description
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
- Confidentiality of records is assured by assigning the subjects research numbers and storing computer files without reference to name, except for a single linking file that links subject's names with their research numbers. Paper records are kept in locked file drawers in a locked room, to which only authorized research personnel have access. When the study is completed, the linking file that links subject's names with their research numbers will be permanently destroyed.
- Furthermore, upon the event of a subject's participation being terminated, all information collected prior to the subject being removed from the study, will be destroyed.
- Personnel involved in the study are acutely sensitive to people's unease about revealing personal information. Research personnel also take the required Program for Education and Evaluation in Responsible Research and Scholarship certification, and take the utmost precautions about protecting confidentiality. When potential subject voices their lack of interest in participating, all identifying information is destroyed. During the study, subjects are reminded that they do not have to answer questions that make them feel uncomfortable
- Data Safety and Monitoring Plan
- No subjects will be recruited or run until the protocol receives full review and approval by the Medical IRB at the University of Michigan. A clinical research associate will accompany all subjects throughout the study. Any minor anxiety arising during the course of the procedures will be immediately assessed, and typically managed with reassurance and simple relaxation techniques. Assessment will always include an evaluation of the subject's ability to continue in the protocol.
- All subjects will be fully informed of all the possible side-effects that could be encountered during the study. Every measure will be taken to protect subjects against even the rarest possible side effects. Principal Investigator, Dr. Chandra Sripada, has extensive prior experience with methylphenidate and the challenges utilized in this study.
- Subjects will be encouraged to contact the investigator if they notice any symptoms or untoward side effects. All subjects will have direct access to the phone numbers and pagers of the study coordinator and the responsible physician (Dr. Sripada), as well as a 24-hour contact number (emergency room services). This information is included in the copy of the consent forms provided to the subjects. 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:
- Mild - Noticeable to the subject, does not interfere with the subject's daily activities, usually does not require additional therapy, dose reduction, or discontinuation of the study.
- Moderate - Interferes with the subject's daily activities, possibly requires additional therapy, but does not require discontinuation of the study.
- Severe - Severely limits the subject's daily activities and may require discontinuation of the study. This would include all adverse events defined as "Serious" by the IRBMED.
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.
- Conditions
- Healthy
- Being tested
- Methylphenidate, Placebo, Easy Behavioral Task, Hard Behavioral Task
- Keywords
- Methylphenidate, Effortful Control, Attention Control, Cognitive functions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethylphenidateDrug
Also called Ritalin
20 mgs of methylphenidate or placebo to be administered one hour before task performance
PlaceboDrug
Also called sugar pill
20 mgs of methylphenidate or a placebo to be administered one hour before task performance
Easy Behavioral TaskBehavioural
Subjects do an easy version of the Letter E Task.
Hard Behavioral TaskBehavioural
Subjects do a hard version of the Letter E Task.
| Study group | Role | What they receive |
|---|---|---|
| Placebo Easy | Other | Healthy participant to be given 20 mgs of a placebo one hour before task performance and will perform an easy task. Receives: Drug: Placebo; Behavioral: Easy Behavioral Task |
| Placebo Hard | Other | Healthy participants are given 20 mgs of placebo one hour before task performance and will perform a hard task. Receives: Drug: Placebo; Behavioral: Hard Behavioral Task |
| Methylphenidate Easy | Other | Healthy participants are given 20 mgs of methylphenidate one hour before task performance and will perform an easy task. Receives: Drug: Methylphenidate; Behavioral: Easy Behavioral Task |
| Methylphenidate Hard | Other | Healthy participants are given 20 mgs of methylphenidate one hour before task performance and will perform a hard task. Receives: Drug: Methylphenidate; Behavioral: Hard Behavioral Task |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 20-30 minutes for task completion
Secondary outcomes (2)
Accuracy on the Multi-Source Interference Task.
Patients completed 200 trials and the percentage of answers correct was calculated.
Measured: 20-30 minutes
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.
Measured: 20-30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2013 (estimated)
- Study startJun 2012
- Primary completion5 Jun 2013
- Study completion24 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chandra Sekhar Sripada, University of Michigan
- Investigators
- Chandra Sekhar Sripada, MD, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01852344
- Sponsor's protocol ID
- K23AA020297
- Acronym
- BDEC
- Status last verified
- Jan 2018
- First submitted
- 1 May 2013
- Last updated
- 8 Jan 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Differences in Effortful Control
- ClinicalTrials.gov ID
- NCT01852344
- Acronym / sponsor ID
- BDEC / K23AA020297
- Conditions
- Healthy
- Keywords
- Methylphenidate, Effortful Control, Attention Control, Cognitive functions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- 5 Jun 2013 (actual)
- Study completion
- 24 Apr 2017 (actual)
- First posted
- 13 May 2013 (estimated)
- Results
- Posted 8 Jan 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
- Confidentiality of records is assured by assigning the subjects research numbers and storing computer files without reference to name, except for a single linking file that links subject's names with their research numbers. Paper records are kept in locked file drawers in a locked room, to which only authorized research personnel have access. When the study is completed, the linking file that links subject's names with their research numbers will be permanently destroyed.
- Furthermore, upon the event of a subject's participation being terminated, all information collected prior to the subject being removed from the study, will be destroyed.
- Personnel involved in the study are acutely sensitive to people's unease about revealing personal information. Research personnel also take the required Program for Education and Evaluation in Responsible Research and Scholarship certification, and take the utmost precautions about protecting confidentiality. When potential subject voices their lack of interest in participating, all identifying information is destroyed. During the study, subjects are reminded that they do not have to answer questions that make them feel uncomfortable
- Data Safety and Monitoring Plan
- No subjects will be recruited or run until the protocol receives full review and approval by the Medical IRB at the University of Michigan. A clinical research associate will accompany all subjects throughout the study. Any minor anxiety arising during the course of the procedures will be immediately assessed, and typically managed with reassurance and simple relaxation techniques. Assessment will always include an evaluation of the subject's ability to continue in the protocol.
- All subjects will be fully informed of all the possible side-effects that could be encountered during the study. Every measure will be taken to protect subjects against even the rarest possible side effects. Principal Investigator, Dr. Chandra Sripada, has extensive prior experience with methylphenidate and the challenges utilized in this study.
- Subjects will be encouraged to contact the investigator if they notice any symptoms or untoward side effects. All subjects will have direct access to the phone numbers and pagers of the study coordinator and the responsible physician (Dr. Sripada), as well as a 24-hour contact number (emergency room services). This information is included in the copy of the consent forms provided to the subjects. 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:
- Mild - Noticeable to the subject, does not interfere with the subject's daily activities, usually does not require additional therapy, dose reduction, or discontinuation of the study.
- Moderate - Interferes with the subject's daily activities, possibly requires additional therapy, but does not require discontinuation of the study.
- Severe - Severely limits the subject's daily activities and may require discontinuation of the study. This would include all adverse events defined as "Serious" by the IRBMED.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo Easy | Other | Drug: Placebo, Behavioral: Easy Behavioral TaskHealthy participant to be given 20 mgs of a placebo one hour before task performance and will perform an easy task. |
| Placebo Hard | Other | Drug: Placebo, Behavioral: Hard Behavioral TaskHealthy participants are given 20 mgs of placebo one hour before task performance and will perform a hard task. |
| Methylphenidate Easy | Other | Drug: Methylphenidate, Behavioral: Easy Behavioral TaskHealthy participants are given 20 mgs of methylphenidate one hour before task performance and will perform an easy task. |
| Methylphenidate Hard | Other | Drug: Methylphenidate, Behavioral: Hard Behavioral TaskHealthy participants are given 20 mgs of methylphenidate one hour before task performance and will perform a hard task. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Age range 18-35
Key exclusion criteria (7 listed)
- Pregnant or nursing (females)
- Any clinically significant medical condition
- Currently taking any medications (i.e., decongestants)
- Currently taking any psychoactive medications
- Alcohol or substance abuse (current or in the past 2 years)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MethylphenidateAlso: Ritalin20 mgs of methylphenidate or placebo to be administered one hour before task performance | Drug | Methylphenidate Easy, Methylphenidate Hard |
| PlaceboAlso: sugar pill20 mgs of methylphenidate or a placebo to be administered one hour before task performance | Drug | Placebo Easy, Placebo Hard |
| Easy Behavioral TaskSubjects do an easy version of the Letter E Task. | Behavioural | Methylphenidate Easy, Placebo Easy |
| Hard Behavioral TaskSubjects do a hard version of the Letter E Task. | Behavioural | Methylphenidate Hard, Placebo Hard |
Primary outcome
Reaction Time on the Multi-Source Interference Task
Time frame: 20-30 minutes for task completion
Reaction time on the Multi-Source Interference Task is measured in milliseconds. Participants were given 200 trials and their mean reaction time was calculated.
2 secondary outcomes
Accuracy on the Multi-Source Interference Task.
Time frame: 20-30 minutes
Reaction Time Variability on the Multi-Source Interference Task.
Time frame: 20-30 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chandra Sekhar Sripada, MD, PhD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Methylphenidate, Easy Behavioral Task and Hard Behavioral Task in people with Healthy, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Jan 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reaction Time on the Multi-Source Interference Task (time frame: 20-30 minutes for task completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2018.