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

Primary Purpose

Attention-Deficit/Hyperactivity Disorder

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Lisdexamfetamine Dimesylate
Atomoxetine Hydrochloride
Sponsored by
Shire
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention-Deficit/Hyperactivity Disorder focused on measuring ADHD

Eligibility Criteria

6 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Harmonex Neuroscience Research, Inc
  • Clinical Study Centers, LLC
  • Shanti Clinical Trials
  • Psychiatric Centers at San Diego Feighner Research
  • Elite Clinical Trials, Inc.
  • Sarkis Clinical Trials
  • Amedica Research Institute, Inc.
  • Fidelity Clinical Research, Inc.
  • Clinical Neuroscience Solutions, INC
  • Northwest Behavioral Research Center
  • Capstone Clinical Research
  • Baber Psychiatric Associates
  • Clinco
  • Heartland Research Associates, LLC
  • Four Rivers Clinical Research, Inc
  • Louisianna Research Associates
  • Office of Marc Hertzman, MD, PC
  • Rochester Center for Behavioral Medicine
  • Midwest Research Group/Saint Charles Psychiatric Associates
  • Premier Psychiatric Research Institute, LLC
  • Center for Psychiatry and Behavioral Medicine, Inc.
  • Children's Specialized Hospital
  • Richmond Behavioral Associates
  • Triangle Neuropsychiatry, PLLC
  • Innovis Health
  • IPS Research Company
  • Cyn3rgy Research
  • CRI Worldwide, LLC Kirkbride Division
  • Future Search Clinical Trials
  • Red Oak Psychiatry Association, PA
  • Western Clinical Investigations
  • Cerebral Research, LLC
  • Lifetree Clinical Research
  • Eastside Therapeutic Resource
  • ZiekenhuisNetwerk Antwerpen
  • Universitair Ziekenhuis Gasthuisberg
  • Child and Adolescent Centre
  • Centre for Anxiety Attention Deficit and Trauma
  • AK Karan Holdings, Ltd.
  • The Kids Clinic
  • University of Saskatchewan
  • Albert-Ludwigs-Universitat Freiburg
  • Zentralinstitut für Seelische Gesundheit Mannheim
  • Schwerpunktpraxis für Entwicklung und Lernen
  • Medizinisches Studienzentrum Würzburg
  • Klinikum Frankfurt/Oder
  • Praxis Dr. Wolff
  • Szegedi Tudományegyetem Gyermek es lfjusagpszichlatrlai Osztaly
  • Vadaskert Korhaz es Szakambulancia Gyermek es lfjusagpszichiatria
  • Bekes Megyei Kepviselotestulet Pandy Kalman Korhaza
  • Gyermek- es lfjusagpszichiatriai Szakrendeles es Gondozo
  • Azienda Ospedaliero-Universitaria di Cagliari
  • Katedra i Klinika Psychiatarii
  • Samodzielny Publiczny Dzieciecy Szpital Kliniczny
  • Hospital Son Llàtzer
  • Hospital Sant Joan de Deu
  • Hospital Marítimo, Unidad de Salud Mental Infanto-Juvenil (USMI-J
  • Hospital Universitario de Canarias
  • Complejo Hospitalario Universitario de Badajoz
  • Hospital Clinic i Provincial de Barcelona
  • Drottning Silvias Barnsjukhus
  • Astrid Lindgren Children's Hospital/Karolinska University Hospital
  • Basildon Hospital
  • Tayside Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Lisdexamfetamine Dimesylate

Atomoxetine Hydrochloride

Arm Description

Outcomes

Primary Outcome Measures

Time to First Response
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)
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
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
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
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
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)
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
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.

Full Information

First Posted
April 14, 2010
Last Updated
June 1, 2021
Sponsor
Shire
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1. Study Identification

Unique Protocol Identification Number
NCT01106430
Brief Title
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

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
June 28, 2010 (Actual)
Primary Completion Date
July 19, 2012 (Actual)
Study Completion Date
July 19, 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shire

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention-Deficit/Hyperactivity Disorder
Keywords
ADHD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
267 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lisdexamfetamine Dimesylate
Arm Type
Experimental
Arm Title
Atomoxetine Hydrochloride
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Lisdexamfetamine Dimesylate
Other Intervention Name(s)
Vyvanse
Intervention Description
Oral 30, 50, or 70mg once-daily for 9 weeks
Intervention Type
Drug
Intervention Name(s)
Atomoxetine Hydrochloride
Other Intervention Name(s)
Strattera
Intervention Description
Oral 10mg to 100mg once-daily for 9 weeks
Primary Outcome Measure Information:
Title
Time to First Response
Description
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).
Time Frame
9 weeks
Secondary Outcome Measure Information:
Title
Percent of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores - Last Observation Carried Forward (LOCF)
Description
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.
Time Frame
9 weeks
Title
Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-Fourth Edition (ADHD-RS-IV) Total Score at 9 Weeks - LOCF
Description
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.
Time Frame
Baseline and 9 weeks
Title
Change From Baseline in the Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P) Global Score at Up to 9 Weeks
Description
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.
Time Frame
Baseline and up to 9 weeks
Title
Health Utilities Index-2 (HUI-2) Scores at Up to 9 Weeks
Description
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.
Time Frame
up to 9 weeks
Title
Change From Baseline in Brief Psychiatric Rating Scale for Children (BPRS-C) Total Score at Up to 9 Weeks
Description
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.
Time Frame
Baseline and up to 9 weeks
Title
Columbia-Suicide Severity Rating Scale (C-SSRS)
Description
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.
Time Frame
9 weeks
Title
Udvalg for Kliniske Undersogelser Side Effect Rating Scale - Clinician (UKU-SERS-Clin) With Side Effects Scores >=1
Description
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.
Time Frame
9 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
Facility Name
Harmonex Neuroscience Research, Inc
City
Dothan
State/Province
Alabama
ZIP/Postal Code
36303
Country
United States
Facility Name
Clinical Study Centers, LLC
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Shanti Clinical Trials
City
Colton
State/Province
California
ZIP/Postal Code
92324
Country
United States
Facility Name
Psychiatric Centers at San Diego Feighner Research
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
Elite Clinical Trials, Inc.
City
Wildomar
State/Province
California
ZIP/Postal Code
92595
Country
United States
Facility Name
Sarkis Clinical Trials
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
Facility Name
Amedica Research Institute, Inc.
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33013
Country
United States
Facility Name
Fidelity Clinical Research, Inc.
City
Lauderhill
State/Province
Florida
ZIP/Postal Code
33319
Country
United States
Facility Name
Clinical Neuroscience Solutions, INC
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Northwest Behavioral Research Center
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30076
Country
United States
Facility Name
Capstone Clinical Research
City
Libertyville
State/Province
Illinois
ZIP/Postal Code
60048
Country
United States
Facility Name
Baber Psychiatric Associates
City
Naperville
State/Province
Illinois
ZIP/Postal Code
60563
Country
United States
Facility Name
Clinco
City
Terre Haute
State/Province
Indiana
ZIP/Postal Code
47802
Country
United States
Facility Name
Heartland Research Associates, LLC
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67207
Country
United States
Facility Name
Four Rivers Clinical Research, Inc
City
Paducah
State/Province
Kentucky
ZIP/Postal Code
42003
Country
United States
Facility Name
Louisianna Research Associates
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70114
Country
United States
Facility Name
Office of Marc Hertzman, MD, PC
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20852
Country
United States
Facility Name
Rochester Center for Behavioral Medicine
City
Rochester Hills
State/Province
Michigan
ZIP/Postal Code
48307
Country
United States
Facility Name
Midwest Research Group/Saint Charles Psychiatric Associates
City
Saint Charles
State/Province
Missouri
ZIP/Postal Code
63301
Country
United States
Facility Name
Premier Psychiatric Research Institute, LLC
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68526
Country
United States
Facility Name
Center for Psychiatry and Behavioral Medicine, Inc.
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Children's Specialized Hospital
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08755
Country
United States
Facility Name
Richmond Behavioral Associates
City
Staten Island
State/Province
New York
ZIP/Postal Code
10312
Country
United States
Facility Name
Triangle Neuropsychiatry, PLLC
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27707
Country
United States
Facility Name
Innovis Health
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58103
Country
United States
Facility Name
IPS Research Company
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
Cyn3rgy Research
City
Gresham
State/Province
Oregon
ZIP/Postal Code
97030
Country
United States
Facility Name
CRI Worldwide, LLC Kirkbride Division
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19139
Country
United States
Facility Name
Future Search Clinical Trials
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Red Oak Psychiatry Association, PA
City
Houston
State/Province
Texas
ZIP/Postal Code
77090
Country
United States
Facility Name
Western Clinical Investigations
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79423
Country
United States
Facility Name
Cerebral Research, LLC
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78247
Country
United States
Facility Name
Lifetree Clinical Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84106
Country
United States
Facility Name
Eastside Therapeutic Resource
City
Kirkland
State/Province
Washington
ZIP/Postal Code
98033
Country
United States
Facility Name
ZiekenhuisNetwerk Antwerpen
City
Hoboken
State/Province
Antwerpen
ZIP/Postal Code
2660
Country
Belgium
Facility Name
Universitair Ziekenhuis Gasthuisberg
City
Leuven
State/Province
Flemish Brabant
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Child and Adolescent Centre
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6H 1P7
Country
Canada
Facility Name
Centre for Anxiety Attention Deficit and Trauma
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8S 1B7
Country
Canada
Facility Name
AK Karan Holdings, Ltd.
City
Oakville
State/Province
Ontario
ZIP/Postal Code
L6J 0B2
Country
Canada
Facility Name
The Kids Clinic
City
Whitby
State/Province
Ontario
ZIP/Postal Code
L1N 8M7
Country
Canada
Facility Name
University of Saskatchewan
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 0W8
Country
Canada
Facility Name
Albert-Ludwigs-Universitat Freiburg
City
Freiburg
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
79104
Country
Germany
Facility Name
Zentralinstitut für Seelische Gesundheit Mannheim
City
Mannheim
State/Province
Baden-wuerttemberg
ZIP/Postal Code
68159
Country
Germany
Facility Name
Schwerpunktpraxis für Entwicklung und Lernen
City
Bamberg
State/Province
Bayern
ZIP/Postal Code
96047
Country
Germany
Facility Name
Medizinisches Studienzentrum Würzburg
City
Wurzburg
State/Province
Bayern
ZIP/Postal Code
97070
Country
Germany
Facility Name
Klinikum Frankfurt/Oder
City
Frankfurt/Oder
State/Province
Brandenburg
ZIP/Postal Code
15236
Country
Germany
Facility Name
Praxis Dr. Wolff
City
Hagen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
58093
Country
Germany
Facility Name
Szegedi Tudományegyetem Gyermek es lfjusagpszichlatrlai Osztaly
City
Szeged
State/Province
Csongrad
ZIP/Postal Code
6720
Country
Hungary
Facility Name
Vadaskert Korhaz es Szakambulancia Gyermek es lfjusagpszichiatria
City
Budapest
Country
Hungary
Facility Name
Bekes Megyei Kepviselotestulet Pandy Kalman Korhaza
City
Gyula
ZIP/Postal Code
5700
Country
Hungary
Facility Name
Gyermek- es lfjusagpszichiatriai Szakrendeles es Gondozo
City
Pecs
Country
Hungary
Facility Name
Azienda Ospedaliero-Universitaria di Cagliari
City
Cagliari
ZIP/Postal Code
9124
Country
Italy
Facility Name
Katedra i Klinika Psychiatarii
City
Bydgoszcz
State/Province
Kujawsko-Pomorskie
ZIP/Postal Code
85-096
Country
Poland
Facility Name
Samodzielny Publiczny Dzieciecy Szpital Kliniczny
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
00-576
Country
Poland
Facility Name
Hospital Son Llàtzer
City
Palma de Mallorca
State/Province
Baleares
ZIP/Postal Code
7198
Country
Spain
Facility Name
Hospital Sant Joan de Deu
City
Esplugues De Llobregat
State/Province
Barcelona
ZIP/Postal Code
08950
Country
Spain
Facility Name
Hospital Marítimo, Unidad de Salud Mental Infanto-Juvenil (USMI-J
City
Torremolinos
State/Province
Malaga
ZIP/Postal Code
29620
Country
Spain
Facility Name
Hospital Universitario de Canarias
City
San Cristobal De La laguna
State/Province
Santa Cruz De Tenerife
ZIP/Postal Code
38320
Country
Spain
Facility Name
Complejo Hospitalario Universitario de Badajoz
City
Badajoz
ZIP/Postal Code
6010
Country
Spain
Facility Name
Hospital Clinic i Provincial de Barcelona
City
Barcelona
ZIP/Postal Code
8036
Country
Spain
Facility Name
Drottning Silvias Barnsjukhus
City
Goteborg
ZIP/Postal Code
411 18
Country
Sweden
Facility Name
Astrid Lindgren Children's Hospital/Karolinska University Hospital
City
Stockholm
ZIP/Postal Code
141 86
Country
Sweden
Facility Name
Basildon Hospital
City
Basildon
State/Province
Essex
ZIP/Postal Code
SS16 5NL
Country
United Kingdom
Facility Name
Tayside Children's Hospital
City
Dundee
State/Province
Scotland
ZIP/Postal Code
DD1 9SY
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
23959815
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.
Results Reference
result
PubMed Identifier
25999292
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.
Results Reference
derived
PubMed Identifier
25038977
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.
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Comparison of Lisdexamfetamine Dimesylate With Atomoxetine HCl in Attention-Deficit/Hyperactivity Disorder (ADHD) Subjects With an Inadequate Response to Methylphenidate

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