Behavioral Differences in Effortful Control

NCT01852344 | Completed Results

• 1 other identifier: K23AA020297
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

Effortful control refers to the mental processes that help a person to regulate his or her own attention, thoughts, and emotions. This study will examine behavioral differences in healthy individuals when performing a task that induces fatigue. The purpose of this study is to examine the effects of methylphenidate on the cognitive functions in healthy individuals when performing fatiguing cognitive tasks.

Conditions

Healthy

Keywords

Methylphenidate; Effortful Control; Attention Control; Cognitive functions

Outcome Measures

Primary Outcomes (1)

• Reaction Time on the Multi-Source Interference Task

  Reaction time on the Multi-Source Interference Task is measured in milliseconds. Participants were given 200 trials and their mean reaction time was calculated.

  20-30 minutes for task completion

Secondary Outcomes (2)

• Accuracy on the Multi-Source Interference Task.

  20-30 minutes

• Reaction Time Variability on the Multi-Source Interference Task.

  20-30 minutes

Study Arms (4)

Placebo Easy

OTHER

Healthy participant to be given 20 mgs of a placebo one hour before task performance and will perform an easy task.

Drug: Placebo; Behavioral: Easy Behavioral Task

Placebo Hard

OTHER

Healthy participants are given 20 mgs of placebo one hour before task performance and will perform a hard task.

Drug: Placebo; Behavioral: Hard Behavioral Task

Methylphenidate Easy

OTHER

Healthy participants are given 20 mgs of methylphenidate one hour before task performance and will perform an easy task.

Drug: Methylphenidate; Behavioral: Easy Behavioral Task

Methylphenidate Hard

OTHER

Healthy participants are given 20 mgs of methylphenidate one hour before task performance and will perform a hard task.

Drug: Methylphenidate; Behavioral: Hard Behavioral Task

Interventions

Methylphenidate DRUG

20 mgs of methylphenidate or placebo to be administered one hour before task performance

Also known as: Ritalin

Methylphenidate Easy; Methylphenidate Hard

Placebo DRUG

20 mgs of methylphenidate or a placebo to be administered one hour before task performance

Also known as: sugar pill

Placebo Easy; Placebo Hard

Easy Behavioral Task BEHAVIORAL

Subjects do an easy version of the Letter E Task.

Methylphenidate Easy; Placebo Easy

Hard Behavioral Task BEHAVIORAL

Subjects do a hard version of the Letter E Task.

Methylphenidate Hard; Placebo Hard

Eligibility Criteria

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

You may qualify if:

• Age range 18-35

You may not qualify if:

• Pregnant or nursing (females)
• Any clinically significant medical condition
• Currently taking any medications (i.e., decongestants)
• Currently taking any psychoactive medications
• Alcohol or substance abuse (current or in the past 2 years)
• Liver or Kidney disease
• Any clinically significant personal or family history of cardiac problems

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

Rachel Upjohn Building, East Medical Campus

Ann Arbor, Michigan, 48109-2700, United States

Location

MeSH Terms

Interventions

Methylphenidate; Sugars

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbohydrates

Results Point of Contact

• Title: Dr. Chandra Sripada, MD PhD
• Organization: University of Michigan

csripada@umich.edu

Study Officials

• Chandra Sekhar Sripada, MD, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Psychiatry, Medical School

Study Record Dates

• First Submitted: May 1, 2013
• First Posted: May 13, 2013
• Study Start: June 1, 2012
• Primary Completion: June 5, 2013
• Study Completion: April 24, 2017
• Last Updated: January 8, 2018
• Results First Posted: January 8, 2018

Record last verified: 2018-01

Locations

US (1)