Trial record 24 of 106 for:    ADHD | Open Studies | United States | Child, Adult

Motivated Behavior in Adults With and Without ADHD (MOBE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2016 by Duke University
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT02630017
First received: December 8, 2015
Last updated: June 20, 2016
Last verified: June 2016
  Purpose
To investigate the effects of methylphenidate on motivated behavior in adults with and without ADHD

Condition Intervention
ADHD
Drug: methylphenidate
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: Motivated Behavior in Adults With and Without ADHD

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Change in motivated behavior on the bandit task [ Time Frame: 1 hour post drug administration ]

Estimated Enrollment: 30
Study Start Date: February 2016
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Drug condition
40 mg methylphenidate on one study day
Drug: methylphenidate
Placebo Comparator: Placebo condition
matching placebo on other study day
Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. generally healthy
  2. between the ages of 18-45
  3. 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.
  4. ADHD subjects meet criteria for a primary diagnosis of ADHD, any subtype, based on DSM-5

Exclusion Criteria:

  1. inability to attend all required experimental sessions
  2. significant health problems (e.g., current and uncontrolled liver, lung, or heart problems, current or past seizure disorder, serious head trauma)
  3. primary diagnosis of Axis I psychiatric disorders other than ADHD (e.g., depression, anxiety disorder, schizophrenia)
  4. meet DSM-5 criteria for substance use disorder other than nicotine in the past 12 months
  5. use of psychoactive medications in the past 6 months as indicated by self-report
  6. positive urine drug screen for drugs or positive breath alcohol concentration
  7. contraindications for MPH
  8. among women, nursing or a positive pregnancy test
  9. IQ < 80 on Kaufman Brief Intelligence Test, 2nd edition
  10. allergy to lactose
  11. 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)
  12. body mass ratio > 30
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02630017

Locations
United States, North Carolina
Duke University Recruiting
Durham, North Carolina, United States, 27705
Contact: Merideth Addicott, PhD    919-684-5237    merideth.addicott@duke.edu   
Principal Investigator: Merideth A Addicott, PhD         
Sponsors and Collaborators
Duke University
  More Information

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02630017     History of Changes
Other Study ID Numbers: Pro00068353 
Study First Received: December 8, 2015
Last Updated: June 20, 2016
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:
Methylphenidate
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on January 23, 2017