Clinical trial NCT01106430: Comparison of Lisdexamfetamine Dimesylate With Atomoxetine HCl in Attention-Deficit/Hyperactivity Disorder (ADHD) Subjects With an Inadequate Response to Methylphenidate
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Attention-Deficit/Hyperactivity Disorder
Keywords: ADHD
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2010-04-19
Enrollment: 267
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Time to First Response
timeFrame: 9 weeks
Secondary outcomes:
measure: Percent of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores - Last Observation Carried Forward (LOCF)
timeFrame: 9 weeks
measure: Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-Fourth Edition (ADHD-RS-IV) Total Score at 9 Weeks - LOCF
timeFrame: Baseline and 9 weeks
measure: Change From Baseline in the Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P) Global Score at Up to 9 Weeks
timeFrame: Baseline and up to 9 weeks
measure: Health Utilities Index-2 (HUI-2) Scores at Up to 9 Weeks
timeFrame: up to 9 weeks
measure: Change From Baseline in Brief Psychiatric Rating Scale for Children (BPRS-C) Total Score at Up to 9 Weeks
timeFrame: Baseline and up to 9 weeks
measure: Columbia-Suicide Severity Rating Scale (C-SSRS)
timeFrame: 9 weeks
measure: Udvalg for Kliniske Undersogelser Side Effect Rating Scale - Clinician (UKU-SERS-Clin) With Side Effects Scores >=1
timeFrame: 9 weeks
Other outcomes:
Locations:
city: Dothan
country: United States
facility: Harmonex Neuroscience Research, Inc
state: Alabama
city: Little Rock
country: United States
facility: Clinical Study Centers, LLC
state: Arkansas
city: Colton
country: United States
facility: Shanti Clinical Trials
state: California
city: San Diego
country: United States
facility: Psychiatric Centers at San Diego Feighner Research
state: California
city: Wildomar
country: United States
facility: Elite Clinical Trials, Inc.
state: California
city: Gainesville
country: United States
facility: Sarkis Clinical Trials
state: Florida
city: Hialeah
country: United States
facility: Amedica Research Institute, Inc.
state: Florida
city: Lauderhill
country: United States
facility: Fidelity Clinical Research, Inc.
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions, INC
state: Florida
city: Roswell
country: United States
facility: Northwest Behavioral Research Center
state: Georgia
city: Libertyville
country: United States
facility: Capstone Clinical Research
state: Illinois
city: Naperville
country: United States
facility: Baber Psychiatric Associates
state: Illinois
city: Terre Haute
country: United States
facility: Clinco
state: Indiana
city: Wichita
country: United States
facility: Heartland Research Associates, LLC
state: Kansas
city: Paducah
country: United States
facility: Four Rivers Clinical Research, Inc
state: Kentucky
city: New Orleans
country: United States
facility: Louisianna Research Associates
state: Louisiana
city: Rockville
country: United States
facility: Office of Marc Hertzman, MD, PC
state: Maryland
city: Rochester Hills
country: United States
facility: Rochester Center for Behavioral Medicine
state: Michigan
city: Saint Charles
country: United States
facility: Midwest Research Group/Saint Charles Psychiatric Associates
state: Missouri
city: Lincoln
country: United States
facility: Premier Psychiatric Research Institute, LLC
state: Nebraska
city: Las Vegas
country: United States
facility: Center for Psychiatry and Behavioral Medicine, Inc.
state: Nevada
city: Toms River
country: United States
facility: Children's Specialized Hospital
state: New Jersey
city: Staten Island
country: United States
facility: Richmond Behavioral Associates
state: New York
city: Durham
country: United States
facility: Triangle Neuropsychiatry, PLLC
state: North Carolina
city: Fargo
country: United States
facility: Innovis Health
state: North Dakota
city: Oklahoma City
country: United States
facility: IPS Research Company
state: Oklahoma
city: Gresham
country: United States
facility: Cyn3rgy Research
state: Oregon
city: Philadelphia
country: United States
facility: CRI Worldwide, LLC Kirkbride Division
state: Pennsylvania
city: Austin
country: United States
facility: Future Search Clinical Trials
state: Texas
city: Houston
country: United States
facility: Red Oak Psychiatry Association, PA
state: Texas
city: Lubbock
country: United States
facility: Western Clinical Investigations
state: Texas
city: San Antonio
country: United States
facility: Cerebral Research, LLC
state: Texas
city: Salt Lake City
country: United States
facility: Lifetree Clinical Research
state: Utah
city: Kirkland
country: United States
facility: Eastside Therapeutic Resource
state: Washington
city: Hoboken
country: Belgium
facility: ZiekenhuisNetwerk Antwerpen
state: Antwerpen
city: Leuven
country: Belgium
facility: Universitair Ziekenhuis Gasthuisberg
state: Flemish Brabant
city: Edmonton
country: Canada
facility: Child and Adolescent Centre
state: Alberta
city: Hamilton
country: Canada
facility: Centre for Anxiety Attention Deficit and Trauma
state: Ontario
city: Oakville
country: Canada
facility: AK Karan Holdings, Ltd.
state: Ontario
city: Whitby
country: Canada
facility: The Kids Clinic
state: Ontario
city: Saskatoon
country: Canada
facility: University of Saskatchewan
state: Saskatchewan
city: Freiburg
country: Germany
facility: Albert-Ludwigs-Universitat Freiburg
state: Baden-Wuerttemberg
city: Mannheim
country: Germany
facility: Zentralinstitut für Seelische Gesundheit Mannheim
state: Baden-wuerttemberg
city: Bamberg
country: Germany
facility: Schwerpunktpraxis für Entwicklung und Lernen
state: Bayern
city: Wurzburg
country: Germany
facility: Medizinisches Studienzentrum Würzburg
state: Bayern
city: Frankfurt/Oder
country: Germany
facility: Klinikum Frankfurt/Oder
state: Brandenburg
city: Hagen
country: Germany
facility: Praxis Dr. Wolff
state: Nordrhein-Westfalen
city: Szeged
country: Hungary
facility: Szegedi Tudományegyetem Gyermek es lfjusagpszichlatrlai Osztaly
state: Csongrad
city: Budapest
country: Hungary
facility: Vadaskert Korhaz es Szakambulancia Gyermek es lfjusagpszichiatria
city: Gyula
country: Hungary
facility: Bekes Megyei Kepviselotestulet Pandy Kalman Korhaza
city: Pecs
country: Hungary
facility: Gyermek- es lfjusagpszichiatriai Szakrendeles es Gondozo
city: Cagliari
country: Italy
facility: Azienda Ospedaliero-Universitaria di Cagliari
city: Bydgoszcz
country: Poland
facility: Katedra i Klinika Psychiatarii
state: Kujawsko-Pomorskie
city: Warszawa
country: Poland
facility: Samodzielny Publiczny Dzieciecy Szpital Kliniczny
state: Mazowieckie
city: Palma de Mallorca
country: Spain
facility: Hospital Son Llàtzer
state: Baleares
city: Esplugues De Llobregat
country: Spain
facility: Hospital Sant Joan de Deu
state: Barcelona
city: Torremolinos
country: Spain
facility: Hospital Marítimo, Unidad de Salud Mental Infanto-Juvenil (USMI-J
state: Malaga
city: San Cristobal De La laguna
country: Spain
facility: Hospital Universitario de Canarias
state: Santa Cruz De Tenerife
city: Badajoz
country: Spain
facility: Complejo Hospitalario Universitario de Badajoz
city: Barcelona
country: Spain
facility: Hospital Clinic i Provincial de Barcelona
city: Goteborg
country: Sweden
facility: Drottning Silvias Barnsjukhus
city: Stockholm
country: Sweden
facility: Astrid Lindgren Children's Hospital/Karolinska University Hospital
city: Basildon
country: United Kingdom
facility: Basildon Hospital
state: Essex
city: Dundee
country: United Kingdom
facility: Tayside Children's Hospital
state: Scotland
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.