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Study identifier: NCT01106430 Synced from ClinicalTrials.gov · August 08, 2026
● Study status: Completed

Comparison of Lisdexamfetamine Dimesylate With Atomoxetine HCl in Attention-Deficit/Hyperactivity Disorder (ADHD) Subjects With an Inadequate Response to Methylphenidate

Condition: Attention-Deficit/Hyperactivity Disorder  ·  Sponsor: Shire

PhasePhase 3
Planned participants267
Who can joinAll sexes, 6 Years to 17 Years
Healthy volunteersNoCheck eligibility criteria ↓
Where64 locations · 10 countries

Sponsor, CRO or site team? See where this study is running → — listed sites, countries and recruiting context. Everything below is written for patients and caregivers.

About this study

This study will evaluate how long it takes for ADHD symptoms to improve in subjects who are judged by the Investigator to have had an inadequate response to methylphenidate therapy. The study will also test the safety of Lisdexamfetamine Dimesylate and how well it works.

This description comes directly from the study's public registry record.

Talk to the study team

No contact information is available for this study as per the public registry record.

Always discuss trial participation with your own doctor first.

Full eligibility criteria (exactly as the study team wrote them)

Inclusion Criteria: * Subject has had an historical or current inadequate response to methylphenidate (MPH) treatment. Inadequate response includes but is not limited to the presence of some residual symptoms, with associated impairment inadequate duration of action and/or variability of symptom control, and/or Investigator feels that the subject may derive benefit from an alternative drug treatment to MPH therapy. * Subject is a male or female aged 6-17 years inclusive at the time of consent * Subject must meet Diagnostic and Statistical Manual of Mental Disorders, fourth edition. - Text Revision (DSM IV TR) criteria for a primary diagnosis of ADHD based on a detailed psychiatric evaluation * Subject must have a baseline ADHD-RS-IV total score 28. Exclusion Criteria: * Subject has taken more than 1 MPH treatment (for example, 2 or more different MPH treatments). Examples include but are not limited to RITALIN immediate release (IR) and EQUASYM IR; MEDIKINET IR and CONCERTA; RITALIN long-acting LA and CONCERTA. Note: this does not include subjects who have taken IR MPH for dose titration on a short-term basis (for example, £4 weeks) with an adequate response * In the Investigator's judgement, subject has failed to respond to more than 1 previous course(s) of MPH treatment. Failure to respond includes worsening of symptoms or no change/minimal improvement of symptoms. * Subject has previously been exposed to STRATTERA or to amphetamine therapy * Subject has previously demonstrated intolerable side effects to 1 MPH treatment which limited titration to acceptable efficacy or that required a decrease in dose resulting in unacceptable tolerability and/or efficacy * Subject has a current, controlled (requiring a restricted medication) or uncontrolled, comorbid psychiatric diagnosis with significant symptoms such as any severe comorbid Axis II disorder or severe Axis I disorder or other symptomatic manifestations, such as agitated states, marked anxiety, or tension that, in the opinion of the examining physician, will contraindicate treatment with SPD489 or STRATTERA or confound efficacy or safety assessments. * Subject has a conduct disorder. Oppositional Defiant Disorder is not exclusionary.

Reproduced word-for-word from the public registry record — the study team can answer questions about it.

Locations (64)

Harmonex Neuroscience Research, IncDothan, Alabama, United States
Clinical Study Centers, LLCLittle Rock, Arkansas, United States
Shanti Clinical TrialsColton, California, United States
Psychiatric Centers at San Diego Feighner ResearchSan Diego, California, United States
Elite Clinical Trials, Inc.Wildomar, California, United States
Sarkis Clinical TrialsGainesville, Florida, United States
Amedica Research Institute, Inc.Hialeah, Florida, United States
Fidelity Clinical Research, Inc.Lauderhill, Florida, United States
Clinical Neuroscience Solutions, INCOrlando, Florida, United States
Northwest Behavioral Research CenterRoswell, Georgia, United States
Capstone Clinical ResearchLibertyville, Illinois, United States
Baber Psychiatric AssociatesNaperville, Illinois, United States

+ 52 more locations — full list on the registry record.

More studies in these areas

This study lists sites in the areas below. Each link shows other recruiting studies near that city, from the public registry record.

DothanLittle RockColtonSan Diego

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