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Functional Differences in Effortful Control (FDEC)

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ClinicalTrials.gov Identifier: NCT01993147
Recruitment Status : Terminated (Behavioral manipulation failed so the trial did not occur)
First Posted : November 25, 2013
Last Update Posted : December 2, 2019
Sponsor:
Information provided by (Responsible Party):
Chandra Sekhar Sripada, University of Michigan

Brief Summary:
The purpose of this study was to learn more about the brain circuits involved with effortful control in healthy adult participants. It was planned that the study would enroll 80 participants to a dual task paradigm pilot while undergoing a fMRI scan to assess brain mechanisms that cause the "depletion effect". This effect refers to the observation that people perform more poorly on effortful control tasks after they have already performed task requiring effortful control. Then subsequent study participants would be given either methylphenidate (also known as 'Ritalin') which is FDA approved and the most widely-used medication for Attention Deficit Hyperactivity Disorder (ADHD) or a placebo, which is a sugar pill. Each participant would also perform some computer tasks that have been shown in previous studies to require effortful control while undergoing an fMRI (functional Magnetic Resonance Imaging) which takes a special kind of picture of the brain. The study's goal was to learn more about the brain mechanisms by which methylphenidate improves effortful control. After enrolling the first 50 participants, the study assessed whether a depletion effect was observed in the dual task paradigm. It was found that there was not: there was no statistically significant difference in effortful control performance comparing subjects who did and did not perform a prior effortful control task. Because the behavioral manipulation failed, it was determined that the drug manipulation portion of the study was no longer justified. Thus, after enrolling 50 participants to the pilot part of the study, the decision was made to terminate the study without beginning the trial of methylphenidate.

Condition or disease Intervention/treatment Phase
Healthy Behavioral: Dual task paradigm pilot Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Functional Differences in Effortful Control
Actual Study Start Date : September 12, 2014
Actual Primary Completion Date : June 8, 2015
Actual Study Completion Date : June 8, 2015

Arm Intervention/treatment
Dual Task Paradigm
This arm does not involve any drug intervention, it is an experimental type consisting of 80 subjects to study the dual task paradigm implemented during the fMRI scanning session. 80 subjects will perform the fMRI scan but will not undergo any drug intervention.
Behavioral: Dual task paradigm pilot



Primary Outcome Measures :
  1. Reaction Time on the Multi-Source Interference Task [ Time Frame: 3 hours ]

Secondary Outcome Measures :
  1. Accuracy on the Multi-Source Interference Task [ Time Frame: 3 hours ]
    Accuracy is the calculated percentage of correct responses over total trials

  2. Reaction time variability on the Multi-Source Interference Task [ Time Frame: 3 hours ]
    Reaction Time Variability is the standard deviation of the trial to trial reaction time distribution (the standard deviation is a unitless quantity) on the Multi-Source Interference Task.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Right-handedness

Exclusion Criteria:

  • Any clinically significant personal or family history of cardiac problems
  • Any current Axis I psychiatric disorder (diagnosis as verified by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders-IV)
  • A previous adequate trial with methylphenidate (Ritalin)
  • Currently taking any psychoactive medications
  • Any clinically significant medical condition
  • Any clinically significant neurological problem (seizures, tics, serious head injury)
  • Contraindications to MRI (metal objects in body or claustrophobia)
  • Currently pregnant or lactating
  • Alcohol or substance abuse (current or in the past 2 years)
  • Left-handedness or ambidextrous
  • Liver or kidney disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01993147


Locations
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United States, Michigan
Rachel Upjohn Building, East Medical Campus
Ann Arbor, Michigan, United States, 48109-2700
Sponsors and Collaborators
University of Michigan
Investigators
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Principal Investigator: Chandra Sekhar Sripada, MD, PhD University of Michigan
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Responsible Party: Chandra Sekhar Sripada, Chandra Sekhar Sripada, MD, PhD, Dept. of Psychiatry, UofM, University of Michigan
ClinicalTrials.gov Identifier: NCT01993147    
Other Study ID Numbers: IRB-MED-HUM00074465
First Posted: November 25, 2013    Key Record Dates
Last Update Posted: December 2, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chandra Sekhar Sripada, University of Michigan:
Methylphenidate
Placebo
functional Magnetic Resonance Imaging (fMRI)
Attention Control