Randomized, Double-blind Safety and Efficacy Study of Lisdexamfetamine Dimesylate (LDX) in Children and Adolescents Aged 6-17
- Conditions
- ADHD
- Interventions
- Registration Number
- NCT00763971
- Lead Sponsor
- Shire
- Brief Summary
The main aim of this study is to see if giving LDX to children and adolescents aged 6-17 years with ADHD decreases symptoms of ADHD.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 336
- 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.
- Subject has blood pressure measurements within the 95th percentile for age, gender, and height at Screening and Baseline.
- Subject is able to swallow a capsule.
- Subject has failed to respond to more than one adequate course (dose and duration) of stimulant therapy. One course must have been a long-acting formulation.
- Subject has a conduct disorder. Oppositional Defiant Disorder is not exclusionary.
- Subject is currently considered a suicide risk, has previously made a suicide attempt or has a prior history of, or is currently, demonstrating active suicidal ideation.
- Subject has glaucoma.
- Subject weighs less than 22.7kg (50lbs).
- Subject is significantly overweight based on Centre for Disease Control and Prevention Body Mass Index (BMI)-for-age gender specific charts at Screening. Significantly overweight is defined as a BMI >97th percentile for this study.
- Subject has a documented allergy, hypersensitivity, or intolerance to amphetamine or methylphenidate.
- Subject has a documented allergy, hypersensitivity, or intolerance to any excipients in the test or reference products.
- Subject has a history of seizures (other than infantile febrile seizures), a tic disorder, or a current diagnosis and/or a known family history of Tourette's Disorder.
- Subject has a known history of symptomatic cardiovascular disease, advance arteriosclerosis, structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious cardiac problems that may place them at increased vulnerability to the sympathomimetic effects of a stimulant drug.
- Subject has a known family history of sudden cardiac death or ventricular arrhythmia.
- Subject is well controlled on their current ADHD medication with acceptable tolerability.
- Subject has a pre-existing severe gastrointestinal tract narrowing (pathologic or iatrogenic).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Lisdexamfetamine Dimesylate (LDX) Lisdexamfetamine Dimesylate (LDX) Overencapsulated LDX 30, 50, or 70mg Placebo Placebo Overencapsulated Placebo Methylphenidate Hydrochloride Methylphenidate Hydrochloride Overencapsulated Concerta 18, 36, or 54mg
- Primary Outcome Measures
Name Time Method Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at up to 7 Weeks Baseline and up to 7 weeks The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging 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.
- Secondary Outcome Measures
Name Time Method Change From Baseline in Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P) Global Score at up to 7 Weeks Baseline and up to 7 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.
Columbia-Suicide Severity Rating Scale (C-SSRS) Up to 7 weeks C-SSRS is a 19-item semi-structured interview designed to capture suicide-related thoughts and behaviors.
Health Utilities Index-2 (HUI-2) Scores at up to 7 Weeks Baseline and up to 7 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 the Child Health and Illness Profile, Child Edition: Parent Report Form (CHIP-CE:PRF) Global T-score at up to 7 Weeks Baseline and up to 7 weeks The CHIP-CE:PRF evaluates health-related quality of life. It is composed of 5 domains (satisfaction, comfort, resilience, avoidance, and achievement) consisting of a total of 76 items. The global score is an average of the scores for the 5 domains. The majority of items assess frequency of events using a 5-point response format. There is no range for a total score. Raw scale scores are used to generate T-scores. Higher scores indicate better health.
Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores Up to 7 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 Conner's Parent Rating Scale - Revised (CPRS-R) Total Score at up to 7 Weeks Baseline and up to 7 weeks The Conner's Parent rating Scale-revised short version (CPRS-R) consists of 27 questions graded on a scale from 0 (not true at all) to 3 (very much true) with a total score ranging from 0 to 81. Higher scores are indicative of increased ADHD. This scale allows parents to respond on the basis of the child's behavior and help assess ADHD and evaluate problem behavior.
Change From Baseline in Brief Psychiatric Rating Scale for Children (BPRS-C) Total Score at up to 7 Weeks Baseline and up to 7 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.
Trial Locations
- Locations (49)
Afdeling Psychiatrie, UZ Herestraat 49, Bus 07003
🇧🇪Leuven, Belgium
Universitair Ziekenhuis Gent, Kinder-en Jeugdpsychiatrie, De Pintelaan 185
🇧🇪Ghent, East Flanders, Belgium
Hospital Archet 2
🇫🇷Nice, Cedex 03, France
Hôpital Robert Debré, Service de Psychopathologie de l'Enfant et de l'Adolescent
🇫🇷Paris, Ile-De-France, France
Centre Hospitalier Charles Perrens, Bordeaux, Service de Psychiatrie de l'Enfant et de l'Adolescent
🇫🇷Bordeaux Cédex, France
Hôpital Gui de Chauliac, 80, avenue Augustin Fliche
🇫🇷Montpellier Cedex 05, France
Zentralinstitut für Seelische Gesundheit Mannheim, Klinik für Psychiatrie und Psychotherapie des Kindes-und Jug, J4/J5
🇩🇪Mannheim, Baden Wuttemburg, Germany
Schwerpunktpraxis für Entwicklung und Lernen, Heinrichsdamm 6
🇩🇪Bamberg, Bayern, Germany
Medizinisches Studienzentrum Würzburg, Augustinerstrasse 10
🇩🇪Würzburg, Bayern, Germany
Universität Würzburg, Klinik und Poliklinik fuer Kinder-und Jugendpsychiatrie und Psychotherapie
🇩🇪Würzburg, Bayern, Germany
Universitatsklinikum Gießen und Marburg GmbH, Hans-Sachs-Strasse 4
🇩🇪Marburg, Hessen, Germany
Universitat Gottingen
🇩🇪Göttingen, Niedersachsen, Germany
Klinikum der Johannes Gutenberg-Universität Mainz, Klinik und Poliklinik für Kinder-und Jugendpsychiatrie und-psychotherapie,
🇩🇪Mainz, Rheinland-Pfalz, Germany
Universitätsmedizin Berlin
🇩🇪Berlin, Germany
Albert-Ludwigs-Universitat Freiburg
🇩🇪Freiburg, Germany
Praxis Dr. Walter Robert Otto
🇩🇪Fulda, Germany
Praxis Dr. Wolff
🇩🇪Hagen, Germany
Praxis Dr. med. Friedrich Kaiser und Dr. med. Ingrid Marinesse
🇩🇪Hamburg, Germany
Praxis für Neuropädiatrie, Schomburgstrasse 120
🇩🇪Hamburg, Germany
Gyermek és Ifjúságpszichiátriai Szakrendelés és Gondozó
🇭🇺Pécs, Hungary
Azienda Ospedaliera della 2 Universita di Napoli
🇮🇹Napoli, Italy
Academisch Ziekenhuis Maastricht
🇳🇱Maastricht, Netherlands
Universitair Medisch Centrum Sint Radboud, Reinier Postlaan 10
🇳🇱Nijmegen, Netherlands
Wojewodzki Osrodek Lecznictwa Psychiatrycznego
🇵🇱Torun, Kujawsko-pomorskie, Poland
Gdanski Uniwersytet Medyczna w Gdansku
🇵🇱Gdansk, Pomorskie, Poland
Hospital Sant Joan de Dèu
🇪🇸Esplugues de Llobregat, Barcelona, Spain
Hospital Marítimo, Unidad de Salud Mental Infanto-Juvenil (USMI-J), Carretera del Sanatorio s/n
🇪🇸Torremolinos, Malaga, Spain
Clínica Universitaria de Navarra, Unidad de Psiquiatría Infantil y Adolescente, Dept. de Psiquiatría y Psicología Médica
🇪🇸Pamplona, Navarra, Spain
Complejo Hospitalario Universitario de Badajoz
🇪🇸Badajoz, Spain
Mutua de Terrassa
🇪🇸Barcelona, Spain
Hospital Ramón y Cajal, Servicio de psiquiatría
🇪🇸Madrid, Spain
Utvecklingsneurologiska Enheten (UNE), BUC, Lockerudsv 12
🇸🇪Mariestad, Vastergotland, Sweden
Drottning Silvias Barnsjukhus
🇸🇪Goteborg, Sweden
Astrid Lindgren Children's Hospital, Karolinska University Hospital
🇸🇪Stockholm, Sweden
Basildon Hospital, Child Developement Centre, Nethermayne
🇬🇧Basildon, Essex, United Kingdom
Barn och Ungdomsmedicin klinik Mölnlycke, Ekdalavägen 2,Box 9
🇸🇪Stockholm, Sweden
Lighthouse Child Development Centre, Snakes Lane
🇬🇧Southend-on-Sea, Essex, United Kingdom
Victoria Hospital, Paediatric Unit, Hayfield Road
🇬🇧Kirkcaldy, Fife, Scotland, United Kingdom
Tayside Childrens Hospital, Clinical Research Facility, Level 4
🇬🇧Dundee, Scotland, United Kingdom
Ryegate Children's Centre, Tapton Crescent Road
🇬🇧Sheffield, Yorkshire, United Kingdom
Hospital Universitario de Canarias C/Ofra
🇪🇸San Cristóbal de la Laguna, Santa Cruz De Tenerife, Spain
Università degli Studi di Cagliari, Dipartimento di Neuroscienze
🇮🇹Cagliari, Italy
Azienda Ospedaliera Universitaria Policlinico G. Martino
🇮🇹Messina, Italy
ZiekenhuisNetwerk Antwerpen, Commandant Weynsstraat 165, Campus Hoge Beuken
🇧🇪Hoboken, Antwerp, Belgium
Pándy Kálmán Kórház
🇭🇺Gyula, Hungary
Vadaskert Kórház és Szakambulancia
🇭🇺Budapest, Hungary
Szpital Uniwersytecki im. dr. Antoniego Jurasza w Bydgoszczy
🇵🇱Bydgoszcz, Kujawsko-pomorskie, Poland
Samodzielny Publiczny Dzieciecy Szpital Kliniczny
🇵🇱Warszawa, Mazowieckie, Poland
Szegedi Tudományegyetem
🇭🇺Szeged, Hungary