- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01993147
Functional Differences in Effortful Control (FDEC)
November 27, 2019 updated by: Chandra Sekhar Sripada, University of Michigan
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48109-2700
- Rachel Upjohn Building, East Medical Campus
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 35 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Reaction Time on the Multi-Source Interference Task
Time Frame: 3 hours
|
3 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Accuracy on the Multi-Source Interference Task
Time Frame: 3 hours
|
Accuracy is the calculated percentage of correct responses over total trials
|
3 hours
|
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.
|
3 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Chandra Sekhar Sripada, MD, PhD, University of Michigan
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 12, 2014
Primary Completion (Actual)
June 8, 2015
Study Completion (Actual)
June 8, 2015
Study Registration Dates
First Submitted
November 13, 2013
First Submitted That Met QC Criteria
November 20, 2013
First Posted (Estimate)
November 25, 2013
Study Record Updates
Last Update Posted (Actual)
December 2, 2019
Last Update Submitted That Met QC Criteria
November 27, 2019
Last Verified
November 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- IRB-MED-HUM00074465
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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