Overview

This trial is active, not recruiting.

Condition healthy
Treatments methylphenidate, placebo
Sponsor University of Michigan
Start date October 2013
End date May 2017
Trial size 180 participants
Trial identifier NCT01993147, IRB-MED-HUM00074465

Summary

The purpose of this study is to learn more about the brain circuits involved with effortful control in healthy adult participants. Study participants will be given either methylphenidate (also known as 'Ritalin')which is an FDA approved, most widely-used medication given to those diagnosed with Attention Deficit Hyperactivity Disorder (ADHD)or a placebo, which is a sugar pill. Each participant will 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. Our goal is to learn more about the brain mechanisms by which methylphenidate improves effortful control.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model single group assignment
Masking double blind (subject, investigator)
Primary purpose basic science
Arm
(Placebo Comparator)
Healthy adult participants to be given either 20mgs of Methylphenidate or a placebo one hour before fMRI and task performance.
methylphenidate Ritalin
20mgs of methlyphenidate or placebo to be administered one hour before fMRI and task performance.
placebo sugar pill
20mgs of methylphenidate or a placebo to be administered one hour before fMRI and task performance.
(Active Comparator)
Healthy adult participants to be given either 20mgs of Methylphenidate or a placebo one hour before fMRI and task performance.
methylphenidate Ritalin
20mgs of methlyphenidate or placebo to be administered one hour before fMRI and task performance.
placebo sugar pill
20mgs of methylphenidate or a placebo to be administered one hour before fMRI and task performance.
(No Intervention)
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.

Primary Outcomes

Measure
Reaction Time on the Multi-Source Interference Task
time frame: Two years

Secondary Outcomes

Measure
Accuracy on the Multi-Source Interference Task
time frame: Two years
Reaction time variability on the Multi-Source Interference Task
time frame: Two years

Eligibility Criteria

Male or female participants from 18 years up to 35 years old.

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

Additional Information

Official title Functional Differences in Effortful Control
Principal investigator Chandra Sekhar Sripada, MD, PhD
Description This study involves two total visits. All visits are scheduled at the Rachel Upjohn Building on East Medical Campus of the University of Michigan. Participation in this study will end once the participant has completed both study visits which are a total of 4 hours. The first visit will require one to complete various questionnaires regarding behavior and general health and takes about 1 hour to complete. The second visit will be scheduled approximately 2 to 7 days after the first study visit and includes the fMRI scanning session. The second visit will last about 3 hours.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by University of Michigan.