NCT00557960

Brief Summary

Evaluate the efficacy of treatment with ADDERALL XR and STRATTERA compared to placebo on simulated driving safety and performance of young adults with ADHD as measured by Driving Safety Scores derived by the Driving Simulator.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Feb 2004

Shorter than P25 for phase_3

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 25, 2004

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 25, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 25, 2004

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

November 9, 2007

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 14, 2007

Completed
Last Updated

May 25, 2021

Status Verified

May 1, 2021

Enrollment Period

8 months

First QC Date

November 9, 2007

Last Update Submit

May 21, 2021

Conditions

Attention Deficit Disorder With Hyperactivity

Outcome Measures

Primary Outcomes (1)

  • Overall Driving Safety Score derived by the driving simulator

    Weeks 3 & 6

Secondary Outcomes (3)

  • Driving Safety Scores at individual time points

    2, 7, and 12 hours post-dose at Weeks 3 & 6

  • Cog-Screen Aviator Predictor Score, ADHD-RS, CGI, Self-rating of driving simulator performance questionnaire

    Weeks 3 & 6

  • AEs, laboratory screens, PE, vital signs, ECG

    6 weeks

Interventions

Mixed salts of a single-entity amphetamineDRUG
Also known as: ADDERALL XR
Atomoxetine hydrochlorideDRUG
Also known as: STRATTERA

Eligibility Criteria

Age19 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • primary diagnosis of ADHD
  • not naive to pharmacologic ADHD treatment
  • valid driver's license with a minimum of 3 years driving experience

You may not qualify if:

  • recent history of drug dependence or substance use disorder
  • history of seizure in last 2 years, tic disorder or Tourette's disorder
  • female subject is pregnant or lactating

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington Neuropsychological Institute, LLC

Washington D.C., District of Columbia, United States

Location

Related Publications (1)

  • Kay GG, Michaels MA, Pakull B. Simulated driving changes in young adults with ADHD receiving mixed amphetamine salts extended release and atomoxetine. J Atten Disord. 2009 Jan;12(4):316-29. doi: 10.1177/1087054708322986. Epub 2008 Sep 24.

    PMID: 18815438RESULT

Related Links

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

SLI381Atomoxetine Hydrochloride

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic Chemicals

Study Officials

  • Study Director

    Takeda

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2007

First Posted

November 14, 2007

Study Start

February 25, 2004

Primary Completion

October 25, 2004

Study Completion

October 25, 2004

Last Updated

May 25, 2021

Record last verified: 2021-05

Locations

US(1)