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A Phase 3b, Double-blind, Randomised, Active-controlled, Parallel Group Study to Assess the Time to Response of Lisdexamfetamine Dimesylate to Atomoxetine Hydrochloride in Children and Adolescents Aged 6-17 Years With Attention-Deficit/Hyperactivity Disorder (ADHD) Who Have Had an Inadequate Response to Methylphenidate Therapy

This study is currently Recruiting

November 2011 By Shire Pharmaceutical Development

First Recieved on April 14, 2010

Last Updated on November 8, 2011

Sponsor: Shire Pharmaceutical Development
Collaborators:
Information provided by: Shire Pharmaceutical Development
Identifier: NCT01106430

Purpose

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.

Study Type: Interventional
Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Eligibility

Ages Eligible for Study:6 Years
Genders Eligible for Study:Both
Accepts Healthy Volunteers:No
Criteria

Inclusion Criteria: - Subject has had an historical or current inadequate response to 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.

Investigators

  • Investigator: Ralf W Dittmann, MD, PhD - Principal Investigator - Dept of Child and Adolescent Psychiatry and Psychotherapy, Central Inst of Mental Health

Locations

  • Harmonex Neuroscience Research, Inc

    Dothan, Alabama 36303 United States

  • Clinical Study Centers, LLC

    Little Rock, Arkansas 72205 United States

  • Psychiatric Centers at San Diego Feighner Research

    San Diego, California 92108 United States

  • Elite Clinical Trials, Inc.

    Wildomar, California 92595 United States

  • Sarkis Clinical Trials

    Gainesville, Florida 32607 United States

  • Amedica Research Institute, Inc.

    Hialeah, Florida 33013 United States

  • Clinical Neuroscience Solutions, INC

    Orlando, Florida 32806 United States

  • Northwest Behavioral Research Center

    Roswell, Georgia 30060 United States

  • Capstone Clinical Research

    Libertyville, Illinois 60048 United States

  • Clinco

    Terre Haute, Indiana 47802 United States

  • Four Rivers Clinical Research, Inc

    Paducah, Kentucky 42003 United States

  • Louisianna Research Associates

    New Orleans, Louisiana 70114 United States

  • Mark Hartzman, MD, PC

    Rockville, Maryland 20852 United States

  • Rochester Center for Behavioral Medicine

    Rochester Hills, Michigan 48307 United States

  • Midwest Research Group/Saint Charles Psychiatric Associates

    St. Charles, Missouri 63301 United States

  • Center for Psychiatry and Behavioral Medicine, Inc.

    Las Vegas, Nevada 89128 United States

  • Children's Specialized Hospital

    Tom's River, New Jersey 8755 United States

  • Richmond Behavioral Associates

    Staten Island, New York 10312 United States

  • Triangle Neuropsychiatry, PLLC

    Durham, North Carolina 27707 United States

  • Innovis Health

    Fargo, North Dakota 58104 United States

  • IPS Research Company

    Oklahoma City, Oklahoma 73103 United States

  • CRI Worldwide, LLC Kirkbride Division

    Philadelphia, Pennsylvania 19149 United States

  • Future Search Clinical Trials

    Austin, Texas 78731 United States

  • Red Oak Psychiatry Association, PA

    Houston, Texas 77090 United States

  • Western Clinical Investigations

    Lubbock, Texas 79423 United States

  • Cerebral Research, LLC

    San Antonia, Texas 78247 United States

  • Eastside Therapeutic Resource

    Kirkland, Washington 98033 United States

  • ZiekenhuisNetwerk Antwerpen

    Hoboken, Antwerpen 2660 Belgium

  • Universitair Ziekenhuis Leuven

    Leuven, Flemish Brabant 3000 Belgium

  • Child and Adolescent Centre

    Edmonton, Alberta T5J-3S8 Canada

  • McMaster University Medical Centre

    Hamilton, Ontario L8N 3Z5 Canada

  • AK Karan Holding

    Oakville, Ontario L6J 0B2 Canada

  • The Kids Clinic

    Whitby, Ontario L1N 8M7 Canada

  • L'H?pital de Montr?al pour enfants

    Montreal, Quebec H3Z 1P2 Canada

  • University of Saskatchewan

    Saskatoon, Saskatchewan S7N 0W8 Canada

  • H?pital Robert Debr?

    Paris, Ile-de-france 75019 France

  • Centre Hospitalier Universitaire d'Amiens, H?pital Nord

    Amiens Cedex, Picardie 80054 France

  • H?pital Pierre Wertheimer

    Bron Cedex, 69677 France

  • Centre Hospitalier Universitaire Clocheville

    Tours, 37000 France

  • Zentralinstitut f?r Seelische Gesundheit Mannheim

    Mannheim, Baden-wuerttemberg 68159 Germany

  • Schwerpunktpraxis f?r Entwicklung und Lernen

    Bamberg, Bayern 96047 Germany

  • Medizinisches Studienzentrum W?rzburg

    Wurzburg, Bayern 97070 Germany

  • Azienda Ospedaliero-Universitaria di Cagliari

    Cagliari, 9124 Italy

  • Azienda Ospedaliera della 2? Universit? di Napoli

    Napoli, 80131 Italy

  • Katedra i Klinika Psychiatarii

    Bydgoszcz, Poland

  • Poradnia Psychiatryczna

    Warszawa, Poland

  • Hospital Son Ll?tzer

    Palma de Mallorca, Baleares 7198 Spain

  • Hospital Sant Joan de Deu

    Barcelona, 08950 Spain

  • Hospital Clinic i Provincial de Barcelona

    Barcelona, 8036 Spain

  • Hospital General Universitario Gregorio Mara??n

    Madrid, 28007 Spain

  • Hospital Ram?n y Cajal, Servicio de psiquiatr?a

    Madrid, 28034 Spain

  • Hospital Universitario de Canarias

    San Cristobal, Spain

  • Drottning Silvias Barnsjukhus

    G?teborg, Vastra Gotaland 411 18 Sweden

  • Astrid Lindgren Children's Hospital/Karolinska University Hospital

    Stockholm, 141 86 Sweden

  • Lighthouse Child Development Centre

    Essex, England SS2 6XT United Kingdom

  • Basildon Hospital

    Essex, England SS16 5NL United Kingdom

  • Tayside Children's Hospital

    Dundee, Scotland DD3 6HH United Kingdom

Conditions related to this trial:

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