ADDERALL XR (Mixed Salts of a Single-entity Amphetamine) and STRATTERA ( Atomoxetine Hydrochloride) Compared to Placebo on Simulated Driving Safety and Performance and Cognitive Functioning in Adults With ADHD

Attention Deficit Disorder With Hyperactivity Clinical Trial

Official title:

A Phase IIIb Study to Evaluate the Efficacy and Time Course of Treatment With ADDERALL XR and STRATTERA Compared to Placebo on Simulated Driving Safety and Performance and Cognitive Functioning in Adults With Attention Deficit Hyperactivity Disorder (ADHD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00557960
• Other study ID #: SLI381-316
• Status: Completed
• Phase: Phase 3
• Start date: February 25, 2004
• Est. completion date: October 25, 2004

Study information

• Verified date: May 2021
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: October 25, 2004
• Est. primary completion date: October 25, 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 25 Years

Eligibility

Inclusion Criteria:

• primary diagnosis of ADHD

• not naive to pharmacologic ADHD treatment

• valid driver's license with a minimum of 3 years driving experience

Exclusion Criteria:

• recent history of drug dependence or substance use disorder

• any specific cardiac condition that would, in the opinion of the investigator, require exclusion

• history of seizure in last 2 years, tic disorder or Tourette's disorder

• female subject is pregnant or lactating

Related Conditions & MeSH terms

• Attention Deficit Disorder With Hyperactivity
• Hyperkinesis

Intervention

Drug:
• Mixed salts of a single-entity amphetamine

• Atomoxetine hydrochloride

Locations

Country	Name	City	State
United States	Washington Neuropsychological Institute, LLC	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Shire

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Driving Safety Score derived by the driving simulator		Weeks 3 & 6
Secondary	Driving Safety Scores at individual time points		2, 7, and 12 hours post-dose at Weeks 3 & 6
Secondary	Cog-Screen Aviator Predictor Score, ADHD-RS, CGI, Self-rating of driving simulator performance questionnaire		Weeks 3 & 6
Secondary	AEs, laboratory screens, PE, vital signs, ECG		6 weeks

External Links

•   FDA Recall Information