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Functional Differences in Effortful Control (FDEC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE November 13, 2013
First Posted Date  ICMJE November 25, 2013
Last Update Posted Date December 2, 2019
Actual Study Start Date  ICMJE September 12, 2014
Actual Primary Completion Date June 8, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 27, 2019)
Reaction Time on the Multi-Source Interference Task [ Time Frame: 3 hours ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 20, 2013)
Reaction Time on the Multi-Source Interference Task [ Time Frame: Two years ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 27, 2019)
  • Accuracy on the Multi-Source Interference Task [ Time Frame: 3 hours ]
    Accuracy is the calculated percentage of correct responses over total trials
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 20, 2013)
  • Accuracy on the Multi-Source Interference Task [ Time Frame: Two years ]
    Accuracy is the calculated percentage of correct responses over total trials
  • Reaction time variability on the Multi-Source Interference Task [ Time Frame: Two years ]
    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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures
 (submitted: November 20, 2013)
Quantify functional relationships between brain regions [ Time Frame: Two years ]
We will quantify functional connectivity which is the correlation between the BOLD (Blood Oxygen Level Dependent signal, the signal that is measured by fMRI) time series between anatomical regions of interest that have been identified from previous cognitive regulation studies. These include dorsal lateral prefrontal cortex, anterior insula dorsal anterior cingulate regions.
 
Descriptive Information
Brief Title  ICMJE Functional Differences in Effortful Control
Official Title  ICMJE Functional Differences in Effortful Control
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Healthy
Intervention  ICMJE Behavioral: Dual task paradigm pilot
Study Arms  ICMJE 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.
Intervention: Behavioral: Dual task paradigm pilot
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: November 27, 2019)
50
Original Estimated Enrollment  ICMJE
 (submitted: November 20, 2013)
100
Actual Study Completion Date  ICMJE June 8, 2015
Actual Primary Completion Date June 8, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01993147
Other Study ID Numbers  ICMJE IRB-MED-HUM00074465
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Chandra Sekhar Sripada, University of Michigan
Study Sponsor  ICMJE University of Michigan
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Chandra Sekhar Sripada, MD, PhD University of Michigan
PRS Account University of Michigan
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP