Behavioral Differences in Effortful Control
Condition: Healthy
Study type: Interventional

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.

      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

        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

      i. Data Safety and Monitoring Plan

        1. 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.

        2. 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.

        3. 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.
    

Intervention name(s): Methylphenidate; Placebo; Easy Behavioral Task; Hard Behavioral Task
Intervention type(s): Drug; Drug; Behavioral; Behavioral
Intervention description(s): 20 mgs of methylphenidate or placebo to be administered one hour before task performance; 20 mgs of methylphenidate or a placebo to be administered one hour before task performance; Subjects do an easy version of the Letter E Task.; Subjects do a hard version of the Letter E Task.
Other intervention name(s): Ritalin; sugar pill
Intervention MeSH terms: Methylphenidate
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Methylphenidate; Effortful Control; Attention Control; Cognitive functions