NCT00536419

Brief Summary

The purpose of this study is to determine whether motorcycle drivers with ADHD are at a greater risk for motorcycle accidents, and whether this risk can be mitigated by treatment with methylphenidate. We will evaluate the effectiveness of Methylphenidate on driving performance, among motorcycle drivers, and investigate the correlation between improvement of ADHD symptoms (inattention and impulsivity) and driving performance.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
53

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Sep 2007

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

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

September 1, 2007

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

September 26, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 27, 2007

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

September 27, 2007

Status Verified

September 1, 2007

First QC Date

September 26, 2007

Last Update Submit

September 26, 2007

Conditions

Attention Deficit Hyperactivity Disorder

Outcome Measures

Primary Outcomes (2)

  • Driving Performance

    After 4 days of medication

  • ADHD symptoms (ASRS)

    After 4 days of medication

Secondary Outcomes (2)

  • Clinical Global Impression (CGI)

    After 4 days of medication

  • Adverse effects

    After 4 days of medication

Study Arms (2)

2

PLACEBO COMPARATOR

4 days of placebo

Other: Placebo

1

EXPERIMENTAL

MPH-SODAS at day 1 (0.3/mg/kg/day); day 2 (0.7/mg/kg/day);days 3 and 4 (1.0 mg/kg/day)

Drug: Methylphenidate

Interventions

MethylphenidateDRUG

Methylphenidate SODAS 0.3 mg/kg/day (day 1); 0.7 mg/kg/day (day 2); 1.0 mg/kg/day (days 3 and 4)

1
PlaceboOTHER

Placebo, daily dose, 4 days, oral administration

2

Eligibility Criteria

Age19 Years - 29 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Professional Motorcycle Driver
  • Current diagnosis of ADHD

You may not qualify if:

  • Mental retardation
  • ADHD treatment in the last month
  • Psychosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-003, Brazil

RECRUITING

Related Links

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

  • Luis Augusto P Rohde, MD

    Hospital de Clinicas de Porto Alegre

    PRINCIPAL INVESTIGATOR

  • Claudia M Szobot, MD

    Hospital de Clinicas de Porto Alegre

    STUDY DIRECTOR

Central Study Contacts

Clarissa F Paim

CONTACT

55-51-21018094cfpaim@hcpa.ufrgs.br

Renata R Goncalves

CONTACT

55-51-33928433renata-rfg@uol.com.br

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 26, 2007

First Posted

September 27, 2007

Study Start

September 1, 2007

Study Completion

September 1, 2008

Last Updated

September 27, 2007

Record last verified: 2007-09

Locations

BR(1)