Motivated Behavior in Adults With and Without ADHD

NCT02630017 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: 207259Pro00068353
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 2

Brief Summary

To investigate the effects of methylphenidate on motivated behavior in adults with and without ADHD

Conditions

ADHD

Outcome Measures

Primary Outcomes (1)

• Number of High-effort Selections in the Effort-based Decision Making Task

  Number of high-effort selections in the effort-based decision making task from the placebo to the methylphenidate condition. This is a decision-making task where participants make high- or low-effort choices to earn a small financial reward. High-effort selections require 100 button presses with non-dominant hand pinky finger and low-effort selections require 30 button presses with dominant hand index finger (within 15 seconds). The number of high effort selections are summed across 50 trials of the task. This task measures the willingness to perform effort in relation to changing reward magnitude and probability. This is a basic science experiment, the clinical and/or physiological relevance of these results are not established.

  1 hour post drug (or placebo) administration for each study session

Study Arms (2)

ADHD group

EXPERIMENTAL

Adults with ADHD

Drug: ADHD methylphenidate first, placebo second; Drug: ADHD placebo first, methylphenidate second

non-ADHD group

EXPERIMENTAL

Adults without ADHD

Drug: Non-ADHD methylphenidate first, placebo second; Drug: Non-ADHD placebo first, methylphenidate second

Interventions

ADHD methylphenidate first, placebo second DRUG

double-blind, counter-balanced administration

ADHD group

ADHD placebo first, methylphenidate second DRUG

double-blind, counter-balanced administration

ADHD group

Non-ADHD methylphenidate first, placebo second DRUG

double-blind, counter-balanced administration

non-ADHD group

Non-ADHD placebo first, methylphenidate second DRUG

non-ADHD group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• generally healthy
• between the ages of 18-45
• non-ADHD subjects do not meet criteria for ADHD diagnosis or any subtype as determined by the Conners Diagnostic Interview or any T-Score \> 55 on Inattentive Symptoms, Hyperactive-Impulsive Symptoms, Total Symptoms or ADHD Index subscales of the CAARS.
• ADHD subjects meet criteria for a primary diagnosis of ADHD, any subtype, based on DSM-5

You may not qualify if:

• inability to attend all required experimental sessions
• significant health problems (e.g., current and uncontrolled liver, lung, or heart problems, current or past seizure disorder, serious head trauma)
• primary diagnosis of Axis I psychiatric disorders other than ADHD (e.g., depression, anxiety disorder, schizophrenia)
• meet DSM-5 criteria for substance use disorder other than nicotine in the past 12 months
• use of psychoactive medications in the past 6 months as indicated by self-report
• positive urine drug screen for drugs or positive breath alcohol concentration
• contraindications for MPH
• among women, nursing or a positive pregnancy test
• IQ \< 80 on Kaufman Brief Intelligence Test, 2nd edition
• allergy to lactose
• hypertension (If subject is ≤ 40 years of age and has blood pressure over 135/85 or heart rate over 90 beats per minute. If subject is \> 40 years of age and has blood pressure over 130/80 or heart rate over 88 beats per minute)
• body mass ratio \> 30

Sponsors & Collaborators

• University of Arkansas: lead

Study Sites (2)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Duke University

Durham, North Carolina, 27705, United States

Location

Related Publications (1)

• Addicott MA, Schechter JC, Sapyta JJ, Selig JP, Kollins SH, Weiss MD. Methylphenidate increases willingness to perform effort in adults with ADHD. Pharmacol Biochem Behav. 2019 Aug;183:14-21. doi: 10.1016/j.pbb.2019.06.008. Epub 2019 Jun 18.

  PMID: 31226260 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Results Point of Contact

• Title: Merideth Addicott
• Organization: University of Arkansas for Medical Sciences

maddicott@uams.edu

501-526-8436

Study Officials

• Merideth A Addicott, PhD

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: There are two parallel arms of this study (ADHD or non-ADHD subjects). Within each arm, each subject will be exposed to placebo and a drug (each at a different timepoint in the study). Although all subjects will receive both placebo and the drug, the order of presentation of the placebo and drug is counterbalanced across subjects (i.e., approximately half will receive the drug first and approximately half will receive the placebo first). For both study arms, regardless of whether the placebo is received first or second, the outcome measure will be calculated as the number of high effort selections.

Study Record Dates

• First Submitted: December 8, 2015
• First Posted: December 15, 2015
• Study Start: March 7, 2016
• Primary Completion: September 21, 2018
• Study Completion: September 21, 2018
• Last Updated: August 27, 2021
• Results First Posted: August 27, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)