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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01106430
First Posted: April 19, 2010
Last Update Posted: June 12, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Shire
  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.

Condition Intervention Phase
Attention-Deficit/Hyperactivity Disorder Drug: Lisdexamfetamine Dimesylate Drug: Atomoxetine Hydrochloride Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Shire:

Primary Outcome Measures:
  • Time to First Response [ Time Frame: 9 weeks ]
    Time to first response was defined as a Clinical Global Impression-Improvement (CGI-I) value of 1 (very much improved) or 2 (much improved) first recorded following first dose of investigational product. CGI-I consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).


Secondary Outcome Measures:
  • Percent of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores - Last Observation Carried Forward (LOCF) [ Time Frame: 9 weeks ]
    Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.

  • Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-Fourth Edition (ADHD-RS-IV) Total Score at 9 Weeks - LOCF [ Time Frame: Baseline and 9 weeks ]
    ADHD-RS-IV consists of 18 items scored on a 4-point scale from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54. A decrease in score indicates an improvement in ADHD symptomology.

  • Change From Baseline in the Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P) Global Score at Up to 9 Weeks [ Time Frame: Baseline and up to 9 weeks ]
    The WFIRS-P is a 50-item scale with each item scored from 0 (never/not at all) to 3 (very often/very much). Mean scores range from 0 to 3. Higher scores indicate greater functional impairment.

  • Health Utilities Index-2 (HUI-2) Scores at Up to 9 Weeks [ Time Frame: up to 9 weeks ]
    HUI is used to describe health status and to obtain utility scores by collecting data using one or more questionnaires in formats selected to match the specific study design criteria. Scoring ranges from 0.00 (dead) to 1.00 (perfect health). Higher scores represent better health status.

  • Change From Baseline in Brief Psychiatric Rating Scale for Children (BPRS-C) Total Score at Up to 9 Weeks [ Time Frame: Baseline and up to 9 weeks ]
    The BPRS-C characterizes psychopathology. A total of 21 items are rated on a scale from 0 (not present) to 6 (extremely severe) with a total score ranging from 0 to 126. A decrease in score indicates a reduction in psychopathology.

  • Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: 9 weeks ]
    C-SSRS is a semi-structured interview that captures the occurence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The interview includes definitions and suggested questions to solicit the type of information needed to determine if a suicide-related thought or behaviour occurred. The assessment is done by the nature of the responses, not by a numbered scale.

  • Udvalg for Kliniske Undersogelser Side Effect Rating Scale - Clinician (UKU-SERS-Clin) With Side Effects Scores >=1 [ Time Frame: 9 weeks ]
    UKU-SERS-Clin is composed of 48 items each of which asks about a single side effect. Each side effect is rated based on a 4-point scale ranging from 0 (no or doubtful presence) to 3 (the least favorable rating). The rating is independent of whether the symptom is regarded as related to the investigational product.


Enrollment: 267
Study Start Date: June 2010
Study Completion Date: September 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lisdexamfetamine Dimesylate Drug: Lisdexamfetamine Dimesylate
Oral 30, 50, or 70mg once-daily for 9 weeks
Other Name: Vyvanse
Active Comparator: Atomoxetine Hydrochloride Drug: Atomoxetine Hydrochloride
Oral 10mg to 100mg once-daily for 9 weeks
Other Name: Strattera

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01106430


  Hide Study Locations
Locations
United States, Alabama
Harmonex Neuroscience Research, Inc
Dothan, Alabama, United States, 36303
United States, Arkansas
Clinical Study Centers, LLC
Little Rock, Arkansas, United States, 72205
United States, California
Shanti Clinical Trials
Colton, California, United States, 92324
Psychiatric Centers at San Diego Feighner Research
San Diego, California, United States, 92108
Elite Clinical Trials, Inc.
Wildomar, California, United States, 92595
United States, Florida
Sarkis Clinical Trials
Gainesville, Florida, United States, 32607
Amedica Research Institute, Inc.
Hialeah, Florida, United States, 33013
Fidelity Clinical Research, Inc.
Lauderhill, Florida, United States, 33319
Clinical Neuroscience Solutions, INC
Orlando, Florida, United States, 32806
United States, Georgia
Northwest Behavioral Research Center
Roswell, Georgia, United States, 30076
United States, Illinois
Capstone Clinical Research
Libertyville, Illinois, United States, 60048
Baber Psychiatric Associates
Naperville, Illinois, United States, 60563
United States, Indiana
Clinco
Terre Haute, Indiana, United States, 47802
United States, Kansas
Heartland Research Associates, LLC
Wichita, Kansas, United States, 67207
United States, Kentucky
Four Rivers Clinical Research, Inc
Paducah, Kentucky, United States, 42003
United States, Louisiana
Louisianna Research Associates
New Orleans, Louisiana, United States, 70114
United States, Maryland
Office of Marc Hertzman, MD, PC
Rockville, Maryland, United States, 20852
United States, Michigan
Rochester Center for Behavioral Medicine
Rochester Hills, Michigan, United States, 48307
United States, Missouri
Midwest Research Group/Saint Charles Psychiatric Associates
St. Charles, Missouri, United States, 63301
United States, Nebraska
Premier Psychiatric Research Institute, LLC
Lincoln, Nebraska, United States, 68526
United States, Nevada
Center for Psychiatry and Behavioral Medicine, Inc.
Las Vegas, Nevada, United States, 89128
United States, New Jersey
Children's Specialized Hospital
Toms River, New Jersey, United States, 08755
United States, New York
Richmond Behavioral Associates
Staten Island, New York, United States, 10312
United States, North Carolina
Triangle Neuropsychiatry, PLLC
Durham, North Carolina, United States, 27707
United States, North Dakota
Innovis Health
Fargo, North Dakota, United States, 58103
United States, Oklahoma
IPS Research Company
Oklahoma City, Oklahoma, United States, 73103
United States, Oregon
Cyn3rgy Research
Gresham, Oregon, United States, 97030
United States, Pennsylvania
CRI Worldwide, LLC Kirkbride Division
Philadelphia, Pennsylvania, United States, 19139
United States, Texas
Future Search Clinical Trials
Austin, Texas, United States, 78731
Red Oak Psychiatry Association, PA
Houston, Texas, United States, 77090
Western Clinical Investigations
Lubbock, Texas, United States, 79423
Cerebral Research, LLC
San Antonio, Texas, United States, 78247
United States, Utah
Lifetree Clinical Research
Salt Lake City, Utah, United States, 84106
United States, Washington
Eastside Therapeutic Resource
Kirkland, Washington, United States, 98033
Belgium
ZiekenhuisNetwerk Antwerpen
Hoboken, Antwerpen, Belgium, 2660
Universitair Ziekenhuis Gasthuisberg
Leuven, Flemish Brabant, Belgium, 3000
Canada, Alberta
Child and Adolescent Centre
Edmonton, Alberta, Canada, T6H 1P7
Canada, Ontario
Centre for Anxiety Attention Deficit and Trauma
Hamilton, Ontario, Canada, L8S 1B7
AK Karan Holdings, Ltd.
Oakville, Ontario, Canada, L6J 0B2
The Kids Clinic
Whitby, Ontario, Canada, L1N 8M7
Canada, Saskatchewan
University of Saskatchewan
Saskatoon, Saskatchewan, Canada, S7N 0W8
Germany
Albert-Ludwigs-Universitat Freiburg
Freiburg, Baden-Wuerttemberg, Germany, 79104
Zentralinstitut für Seelische Gesundheit Mannheim
Mannheim, Baden-wuerttemberg, Germany, 68159
Schwerpunktpraxis für Entwicklung und Lernen
Bamberg, Bayern, Germany, 96047
Medizinisches Studienzentrum Würzburg
Wurzburg, Bayern, Germany, 97070
Klinikum Frankfurt/Oder
Frankfurt/Oder, Brandenburg, Germany, 15236
Praxis Dr. Wolff
Hagen, Nordrhein-Westfalen, Germany, 58093
Hungary
Szegedi Tudományegyetem Gyermek es lfjusagpszichlatrlai Osztaly
Szeged, Csongrad, Hungary, 6720
Vadaskert Korhaz es Szakambulancia Gyermek es lfjusagpszichiatria
Budapest, Hungary
Bekes Megyei Kepviselotestulet Pandy Kalman Korhaza
Gyula, Hungary, 5700
Gyermek- es lfjusagpszichiatriai Szakrendeles es Gondozo
Pecs, Hungary
Italy
Azienda Ospedaliero-Universitaria di Cagliari
Cagliari, Italy, 9124
Poland
Katedra i Klinika Psychiatarii
Bydgoszcz, Kujawsko-Pomorskie, Poland, 85-096
Samodzielny Publiczny Dzieciecy Szpital Kliniczny
Warszawa, Mazowieckie, Poland, 00-576
Spain
Hospital Son Llàtzer
Palma de Mallorca, Baleares, Spain, 7198
Hospital Sant Joan de Deu
Esplugues De Llobregat, Barcelona, Spain, 08950
Hospital Marítimo, Unidad de Salud Mental Infanto-Juvenil (USMI-J
Torremolinos, Malaga, Spain, 29620
Hospital Universitario de Canarias
San Cristobal De La laguna, Santa Cruz De Tenerife, Spain, 38320
Complejo Hospitalario Universitario de Badajoz
Badajoz, Spain, 6010
Hospital Clinic i Provincial de Barcelona
Barcelona, Spain, 8036
Sweden
Drottning Silvias Barnsjukhus
Goteborg, Sweden, 411 18
Astrid Lindgren Children's Hospital/Karolinska University Hospital
Stockholm, Sweden, 141 86
United Kingdom
Basildon Hospital
Essex, England, United Kingdom, SS16 5NL
Tayside Children's Hospital
Dundee, Scotland, United Kingdom, DD1 9SY
Sponsors and Collaborators
Shire
Investigators
Principal Investigator: Ralf W Dittmann, MD, PhD Dept of Child and Adolescent Psychiatry and Psychotherapy, Central Inst of Mental Health
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01106430     History of Changes
Other Study ID Numbers: SPD489-317
2009-011745-94 ( EudraCT Number )
First Submitted: April 14, 2010
First Posted: April 19, 2010
Results First Submitted: May 3, 2013
Results First Posted: June 24, 2013
Last Update Posted: June 12, 2014
Last Verified: February 2014

Keywords provided by Shire:
ADHD

Additional relevant MeSH terms:
Disease
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Pathologic Processes
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Methylphenidate
Lisdexamfetamine Dimesylate
Atomoxetine Hydrochloride
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Adrenergic Uptake Inhibitors
Adrenergic Agents