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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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

Other trials in United States

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

  1. 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.
  2. 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.
  3. 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
  4. Data Safety and Monitoring Plan
  5. 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.
  6. 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.
  7. 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 groups in NCT01852344
Study groupRoleWhat they receive
Placebo EasyOtherHealthy 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 HardOtherHealthy 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 EasyOtherHealthy 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 HardOtherHealthy 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.

  1. 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)
  1. Accuracy on the Multi-Source Interference Task.

    Patients completed 200 trials and the percentage of answers correct was calculated.

    Measured: 20-30 minutes

  2. 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.

  1. First posted13 May 2013 (estimated)
  2. Study startJun 2012
  3. Primary completion5 Jun 2013
  4. Study completion24 Apr 2017

Resources

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)
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
Data monitoring committee
No

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.

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Behavioral Differences in Effortful Control | AzTrials