Functional Differences in Effortful Control

NCT01993147 | Terminated

• 1 other identifier: IRB-MED-HUM00074465
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Methylphenidate; Placebo; functional Magnetic Resonance Imaging (fMRI); Attention Control

Outcome Measures

Primary Outcomes (1)

• Reaction Time on the Multi-Source Interference Task

  3 hours

Secondary Outcomes (2)

• Accuracy on the Multi-Source Interference Task

  3 hours

• Reaction time variability on the Multi-Source Interference Task

  3 hours

Study Arms (1)

Dual Task Paradigm

OTHER

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

Interventions

Dual task paradigm pilot BEHAVIORAL

Dual Task Paradigm

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Right-handedness

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

Rachel Upjohn Building, East Medical Campus

Ann Arbor, Michigan, 48109-2700, United States

Location

Study Officials

• Chandra Sekhar Sripada, MD, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chandra Sekhar Sripada, MD, PhD, Dept. of Psychiatry, UofM

Study Record Dates

• First Submitted: November 13, 2013
• First Posted: November 25, 2013
• Study Start: September 12, 2014
• Primary Completion: June 8, 2015
• Study Completion: June 8, 2015
• Last Updated: December 2, 2019

Record last verified: 2019-11

Locations

US (1)