NCT00223561

Brief Summary

The primary purpose of this study is to determine the effects of methylphenidate versus placebo on driving ability of adult ADHD patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Feb 2003

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2003

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2006

Completed
Last Updated

March 1, 2006

Status Verified

February 1, 2006

First QC Date

September 13, 2005

Last Update Submit

February 28, 2006

Conditions

ADHD

Keywords

adult

Outcome Measures

Primary Outcomes (1)

  • Driving test:Standard Deviation of Lateral Position (SDLP, cm);i.e. the weaving of the car [single dose effects]

Secondary Outcomes (3)

  • Other Driving test parameters: Standard Deviation of Speed, mean speed, mean lateral position.

  • Memory test: immediate & delayed word recall, delayed recognition.[single dose effects]

  • Continuous Performance test: RT, %errors [single dose effects]

Interventions

methylphenidateDRUG

Eligibility Criteria

Age21 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • adult ADHD patient over 21 years old
  • valid driver's license for at least 3 years
  • treated with methylphenidate
  • written informed consent

You may not qualify if:

  • use of illicit drugs
  • use of drugs or having medical conditions known to affect driving ability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Utrecht Institute for Pharmaceutical Sciences

Utrecht, 3508 TB, Netherlands

Location

Related Publications (1)

  • Verster JC, Bekker EM, Kooij JJ, Buitelaar JK, Verbaten MN, Volkerts ER, Olivier B. Methylphenidate significantly improves declarative memory functioning of adults with ADHD. Psychopharmacology (Berl). 2010 Oct;212(2):277-81. doi: 10.1007/s00213-010-1952-2. Epub 2010 Jul 20.

    PMID: 20645078DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Methylphenidate

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PhenylacetatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Joris Verster, PhD

    Utrecht Institute for Pharmaceutical Sciences

    PRINCIPAL INVESTIGATOR

  • Edmund Volkerts, PhD

    Utrecht Institute for Pharmaceutical Sciences

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 22, 2005

Study Start

February 1, 2003

Study Completion

February 1, 2006

Last Updated

March 1, 2006

Record last verified: 2006-02

Locations

NL(1)