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

NCT ID: NCT01106430

Last Updated: 2021-06-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 267 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-28
• Study Completion Date: 2012-07-19

Brief Summary

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.

Conditions

Attention-Deficit/Hyperactivity Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Lisdexamfetamine Dimesylate

Group Type: EXPERIMENTAL

Lisdexamfetamine Dimesylate

Intervention Type: DRUG

Oral 30, 50, or 70mg once-daily for 9 weeks

Atomoxetine Hydrochloride

Group Type: ACTIVE_COMPARATOR

Atomoxetine Hydrochloride

Intervention Type: DRUG

Oral 10mg to 100mg once-daily for 9 weeks

Interventions

Lisdexamfetamine Dimesylate

Oral 30, 50, or 70mg once-daily for 9 weeks

Intervention Type: DRUG

Atomoxetine Hydrochloride

Oral 10mg to 100mg once-daily for 9 weeks

Intervention Type: DRUG

Other Intervention Names

Vyvanse; Strattera

Eligibility Criteria

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shire

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Study Director

Role: STUDY_DIRECTOR

Takeda

Locations

Harmonex Neuroscience Research, Inc

Dothan, Alabama, United States

Clinical Study Centers, LLC

Little Rock, Arkansas, United States

Shanti Clinical Trials

Colton, California, United States

Psychiatric Centers at San Diego Feighner Research

San Diego, California, United States

Elite Clinical Trials, Inc.

Wildomar, California, United States

Sarkis Clinical Trials

Gainesville, Florida, United States

Amedica Research Institute, Inc.

Hialeah, Florida, United States

Fidelity Clinical Research, Inc.

Lauderhill, Florida, United States

Clinical Neuroscience Solutions, INC

Orlando, Florida, United States

Northwest Behavioral Research Center

Roswell, Georgia, United States

Capstone Clinical Research

Libertyville, Illinois, United States

Baber Psychiatric Associates

Naperville, Illinois, United States

Clinco

Terre Haute, Indiana, United States

Heartland Research Associates, LLC

Wichita, Kansas, United States

Four Rivers Clinical Research, Inc

Paducah, Kentucky, United States

Louisianna Research Associates

New Orleans, Louisiana, United States

Office of Marc Hertzman, MD, PC

Rockville, Maryland, United States

Rochester Center for Behavioral Medicine

Rochester Hills, Michigan, United States

Midwest Research Group/Saint Charles Psychiatric Associates

Saint Charles, Missouri, United States

Premier Psychiatric Research Institute, LLC

Lincoln, Nebraska, United States

Center for Psychiatry and Behavioral Medicine, Inc.

Las Vegas, Nevada, United States

Children's Specialized Hospital

Toms River, New Jersey, United States

Richmond Behavioral Associates

Staten Island, New York, United States

Triangle Neuropsychiatry, PLLC

Durham, North Carolina, United States

Innovis Health

Fargo, North Dakota, United States

IPS Research Company

Oklahoma City, Oklahoma, United States

Cyn3rgy Research

Gresham, Oregon, United States

CRI Worldwide, LLC Kirkbride Division

Philadelphia, Pennsylvania, United States

Future Search Clinical Trials

Austin, Texas, United States

Red Oak Psychiatry Association, PA

Houston, Texas, United States

Western Clinical Investigations

Lubbock, Texas, United States

Cerebral Research, LLC

San Antonio, Texas, United States

Lifetree Clinical Research

Salt Lake City, Utah, United States

Eastside Therapeutic Resource

Kirkland, Washington, United States

ZiekenhuisNetwerk Antwerpen

Hoboken, Antwerpen, Belgium

Universitair Ziekenhuis Gasthuisberg

Leuven, Flemish Brabant, Belgium

Child and Adolescent Centre

Edmonton, Alberta, Canada

Centre for Anxiety Attention Deficit and Trauma

Hamilton, Ontario, Canada

AK Karan Holdings, Ltd.

Oakville, Ontario, Canada

The Kids Clinic

Whitby, Ontario, Canada

University of Saskatchewan

Saskatoon, Saskatchewan, Canada

Albert-Ludwigs-Universitat Freiburg

Freiburg im Breisgau, Baden-Wurttemberg, Germany

Zentralinstitut für Seelische Gesundheit Mannheim

Mannheim, Baden-Wurttemberg, Germany

Schwerpunktpraxis für Entwicklung und Lernen

Bamberg, Bavaria, Germany

Medizinisches Studienzentrum Würzburg

Würzburg, Bavaria, Germany

Klinikum Frankfurt/Oder

Frankfurt (Oder), Brandenburg, Germany

Praxis Dr. Wolff

Hagen, North Rhine-Westphalia, Germany

Szegedi Tudományegyetem Gyermek es lfjusagpszichlatrlai Osztaly

Szeged, Csongrád megye, Hungary

Vadaskert Korhaz es Szakambulancia Gyermek es lfjusagpszichiatria

Budapest, , Hungary

Bekes Megyei Kepviselotestulet Pandy Kalman Korhaza

Gyula, , Hungary

Gyermek- es lfjusagpszichiatriai Szakrendeles es Gondozo

Pécs, , Hungary

Azienda Ospedaliero-Universitaria di Cagliari

Cagliari, , Italy

Katedra i Klinika Psychiatarii

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland

Samodzielny Publiczny Dzieciecy Szpital Kliniczny

Warsaw, Masovian Voivodeship, Poland

Hospital Son Llàtzer

Palma de Mallorca, Balearic Islands, Spain

Hospital Sant Joan de Deu

Esplugues de Llobregat, Barcelona, Spain

Hospital Marítimo, Unidad de Salud Mental Infanto-Juvenil (USMI-J

Torremolinos, Malaga, Spain

Hospital Universitario de Canarias

San Cristóbal de La Laguna, Santa Cruz De Tenerife, Spain

Complejo Hospitalario Universitario de Badajoz

Badajoz, , Spain

Hospital Clinic i Provincial de Barcelona

Barcelona, , Spain

Drottning Silvias Barnsjukhus

Gothenburg, , Sweden

Astrid Lindgren Children's Hospital/Karolinska University Hospital

Stockholm, , Sweden

Basildon Hospital

Basildon, Essex, United Kingdom

Tayside Children's Hospital

Dundee, Scotland, United Kingdom

Countries

United States; Belgium; Canada; Germany; Hungary; Italy; Poland; Spain; Sweden; United Kingdom

References

Dittmann RW, Cardo E, Nagy P, Anderson CS, Bloomfield R, Caballero B, Higgins N, Hodgkins P, Lyne A, Civil R, Coghill D. Efficacy and safety of lisdexamfetamine dimesylate and atomoxetine in the treatment of attention-deficit/hyperactivity disorder: a head-to-head, randomized, double-blind, phase IIIb study. CNS Drugs. 2013 Dec;27(12):1081-92. doi: 10.1007/s40263-013-0104-8.

Reference Type: RESULT

PMID: 23959815 (View on PubMed)

Nagy P, Hage A, Coghill DR, Caballero B, Adeyi B, Anderson CS, Sikirica V, Cardo E. Functional outcomes from a head-to-head, randomized, double-blind trial of lisdexamfetamine dimesylate and atomoxetine in children and adolescents with attention-deficit/hyperactivity disorder and an inadequate response to methylphenidate. Eur Child Adolesc Psychiatry. 2016 Feb;25(2):141-9. doi: 10.1007/s00787-015-0718-0. Epub 2015 May 22.

Reference Type: DERIVED

PMID: 25999292 (View on PubMed)

Dittmann RW, Cardo E, Nagy P, Anderson CS, Adeyi B, Caballero B, Hodgkins P, Civil R, Coghill DR. Treatment response and remission in a double-blind, randomized, head-to-head study of lisdexamfetamine dimesylate and atomoxetine in children and adolescents with attention-deficit hyperactivity disorder. CNS Drugs. 2014 Nov;28(11):1059-69. doi: 10.1007/s40263-014-0188-9.

Reference Type: DERIVED

PMID: 25038977 (View on PubMed)

Other Identifiers

2009-011745-94

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

SPD489-317

Identifier Type: -

Identifier Source: org_study_id