Functional Differences in Effortful Control | NCT01993147

Studies
Functional Differences in Effortful Control

NCT01993147

Sponsor

University of Michigan

Status

Terminated

Last Update Posted

Dec 2, 2019Actual

Enrollment

50Actual

Phase

Not Applicable

Conditions

Healthy

Interventions

Dual task paradigm pilot

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2019

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Behavioral manipulation failed so the trial did not occur

Expanded Access Info

Start Date

Sep 12, 2014Actual

Primary Completion Date

Jun 8, 2015Actual

Completion Date

Jun 8, 2015Actual

First Submitted Date

Nov 13, 2013

First Submission Date that Met QC Criteria

Nov 20, 2013

First Posted Date

Nov 25, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 27, 2019

Last Update Posted Date

Dec 2, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Chandra Sekhar Sripada, Chandra Sekhar Sripada, MD, PhD, Dept. of Psychiatry, UofM, University of MichiganPrincipal Investigator

Lead Sponsor

University of MichiganOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Dual task paradigm pilot	Behavioral		Dual Task Paradigm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Reaction Time on the Multi-Source Interference Task		3 hours

Secondary Outcomes

Measure	Description	Time Frame
Accuracy on the Multi-Source Interference Task	Accuracy is the calculated percentage of correct responses over total trials	3 hours
Reaction time variability on the Multi-Source Interference Task

Other Outcomes

Not provided

Eligibility Module

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
Liver or kidney disease

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Chandra Sekhar Sripada, MD, PhD	University of Michigan	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rachel Upjohn Building, East Medical Campus		Ann Arbor	Michigan	48109-2700	United States