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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-02-25

Study Completion Date

2004-10-25

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Strattera Treatment in Children With ADHD Who Have Poor Response to Stimulant Therapy

NCT00181948

ADHD

COMPLETED PHASE4

Efficacy Study of Strattera for Treating Attention Disorders in Traumatic Brain Injury (TBI)

NCT00702364

Traumatic Brain INjury

COMPLETED NA

Evaluation of Continuous Symptom Treatment of ADHD

NCT00486122

Attention Deficit Hyperactivity Disorder

COMPLETED PHASE4

Strattera Treatment in Adults With Attention Deficit Hyperactivity Disorder Not Otherwise Specified (ADHD NOS)

NCT00181766

ADHD NOS

COMPLETED PHASE4

Community-based Study Comparing Extended-release Methylphenidate and Atomoxetine in Children With Attention-deficit Hyperactivity Disorder

NCT00866996

Attention Deficit Hyperactivity Disorder

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Attention Deficit Disorder With Hyperactivity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Mixed salts of a single-entity amphetamine

Intervention Type DRUG

Atomoxetine hydrochloride

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

ADDERALL XR STRATTERA

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

19 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No