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Methylphenidate in Healthy Young Adults

NCT00815841 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2008-12-31

No results posted yet for this study

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

Conditions

  • Healthy

Interventions

DRUG

METHYLPHENIDATE

15-20mg during one of the two sessions

Sponsors & Collaborators

  • Shaare Zedek Medical Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2009-12-31
Completion
2009-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00815841 on ClinicalTrials.gov