Methylphenidate in Healthy Young Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00815841
Recruitment Status : Unknown
Verified December 2008 by Shaare Zedek Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : December 31, 2008
Last Update Posted : December 31, 2008
Information provided by:
Shaare Zedek Medical Center

Brief Summary:
Background: There is a paucity of data as to the effect of methylphenidate (MPH) on young adults who do not have attention deficit hyperactivity disorder (ADHD). The existing data is equivocal and focuses on neuropsychological functions that are not always relevant to the clinical aspects of attention. Objective: To determine the effect of MPH on a diagnostic continuous performance task that assesses attention per se (TOVA) and on a decision making test (Modified Gamble Decision Test) in young, healthy adults. Methods: Fifty young adults, men and women ages 20-30, without ADHD, learning disabilities, history of past or present use of MPH or other psychotropic drugs, will be eligible to participate. Design: The experiment will be conducted in 2 sessions, the first lasting 3.5 hours and the second 2.5 hours in a randomized, double-blind prospective design. In the first session, the subjects will be screened for ADHD past and present, major psychiatric diagnosis (depression, anxiety, etc), use of MPH in the past, psychotropic medications or recreational drugs and any other chronic illness; urine will be tested for beta-hCG to rule out pregnancy. Blood pressure and heart rate will be measured. The participants will then be given either placebo or MPH (15-20 mg) and after 90 minutes will proceed to complete the TOVA (that lasts 22 minutes) and Modified Gamble-Decision Test (15 minutes). Before taking the pill and prior to the testing, the subjects will complete the Visual Analogue Scale (VAS) which quantifies their subjective feelings regarding present mental and emotional state. In the second session, 2 weeks later, blood pressure and heart will be measured and the VAS completed prior to and 90 minutes after taking the tablet. The subjects then undergo the TOVA and Modified Gamble-Decision Test. Data Analysis: will be performed using the paired t-tests for parametric variables and one way ANOVA with repeated measurements. Significance: Results of this study are important since MPH is used and abused by healthy students as a "study aid" although its objective effects in normal young adults are not well delineated

Condition or disease Intervention/treatment Phase
Healthy Drug: METHYLPHENIDATE Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Study Start Date : January 2009
Estimated Primary Completion Date : December 2009
Estimated Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

Intervention Details:
    15-20mg during one of the two sessions

Primary Outcome Measures :
  1. The TOVA score [ Time Frame: January - December 2009 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • ages 20-30

Exclusion Criteria:

  • ADHD
  • learning disabilities
  • history of past or present use of MPH or other psychotropic drugs
  • pregnancy
  • chronic illness

Responsible Party: VARDA GROSS-TSUR MD, SHAARE ZEDEK MEDICAL CENTER Identifier: NCT00815841     History of Changes
Other Study ID Numbers: ShaareZMC.ctil
First Posted: December 31, 2008    Key Record Dates
Last Update Posted: December 31, 2008
Last Verified: December 2008

Keywords provided by Shaare Zedek Medical Center:
Determine the effect of MPH on a diagnostic continuous performance task that assesses attention and on a decision making test in young healthy adults

Additional relevant MeSH terms:
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