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Clinical Trials/NCT01993147
NCT01993147
Terminated
Not Applicable

Functional Differences in Effortful Control

University of Michigan1 site in 1 country50 target enrollmentSeptember 12, 2014
ConditionsHealthy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Healthy
Sponsor
University of Michigan
Enrollment
50
Locations
1
Primary Endpoint
Reaction Time on the Multi-Source Interference Task
Status
Terminated
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 12, 2014
End Date
June 8, 2015
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Chandra Sekhar Sripada

Chandra Sekhar Sripada, MD, PhD, Dept. of Psychiatry, UofM

University of Michigan

Eligibility 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

Outcomes

Primary Outcomes

Reaction Time on the Multi-Source Interference Task

Time Frame: 3 hours

Secondary Outcomes

  • Accuracy on the Multi-Source Interference Task(3 hours)
  • Reaction time variability on the Multi-Source Interference Task(3 hours)

Study Sites (1)

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