Functional Differences in Effortful Control

Healthy Clinical Trial

— FDEC  

Official title:

Functional Differences in Effortful Control

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01993147
• Other study ID #: IRB-MED-HUM00074465
• Status: Terminated
• Phase: N/A
• Start date: September 12, 2014
• Est. completion date: June 8, 2015

Study information

• Verified date: November 2019
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 50
• Est. completion date: June 8, 2015
• Est. primary completion date: June 8, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Behavioral:
• Dual task paradigm pilot

Locations

Country	Name	City	State
United States	Rachel Upjohn Building, East Medical Campus	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reaction Time on the Multi-Source Interference Task		3 hours
Secondary	Accuracy on the Multi-Source Interference Task	Accuracy is the calculated percentage of correct responses over total trials	3 hours
Secondary	Reaction time variability on the Multi-Source Interference Task	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