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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
April 14, 2010
April 19, 2010
May 3, 2013
June 24, 2013
June 12, 2014
June 2010
July 2012   (Final data collection date for primary outcome measure)
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).
Clinical Global Impression-Improvement (CGI-I) Score [ 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.
Complete list of historical versions of study NCT01106430 on ClinicalTrials.gov Archive Site
  • 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.
  • ADHD-Rating Scale-IV [ Time Frame: 9 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.
  • Clinical Global Impression-Severity (CGI-S) Score [ Time Frame: 9 weeks ]
    CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)
  • Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: 9 weeks ]
    The C-SSRS is a semi-structured interview that captures the occurrence, severity, and frequency of suicide-related thoughts and behaviours 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 Udvalg for Kliniske Undersøgelser Side Effect Rating Scale (UKU-SERS-Clin) [ Time Frame: 9 weeks ]
    The UKU-SERS-Clin is a comprehensive clinician-rated side effect scale with well-defined items to assess the side effects of psychopharmacological medications. It includes a global assessment of the influence of the reported side effects on daily performance, and an assessment of the probability of the causal relationship (or lack of it) of each item to the medication, which makes it useful for determining subsequent course of action.
  • Health Utilities Index - Mark 2 (HUI-2) [ Time Frame: 9 weeks ]
    The HUI-2 is a standardised measurement of health status and generic health-related quality of life to describe: 1) the experience of patients undergoing therapy, 2) long-term outcomes associated with disease or therapy; 3) the efficacy, effectiveness, and efficiency of healthcare interventions; and 4) the health status of general populations.
  • Brief Psychiatric Rating Scale for Children (BPRS-C) [ Time Frame: 9 weeks ]
    The BPRS-C provides a concise characterisation of the broad range of child and adolescent psychopathology. The 21-item BPRS-C is completed based on the clinician's interview with the child and parent/LAR.
Not Provided
Not Provided
 
Comparison of Lisdexamfetamine Dimesylate With Atomoxetine HCl in Attention-Deficit/Hyperactivity Disorder (ADHD) Subjects With an Inadequate Response to Methylphenidate
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 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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Attention-Deficit/Hyperactivity Disorder
  • Drug: Lisdexamfetamine Dimesylate
    Oral 30, 50, or 70mg once-daily for 9 weeks
    Other Name: Vyvanse
  • Drug: Atomoxetine Hydrochloride
    Oral 10mg to 100mg once-daily for 9 weeks
    Other Name: Strattera
  • Experimental: Lisdexamfetamine Dimesylate
    Intervention: Drug: Lisdexamfetamine Dimesylate
  • Active Comparator: Atomoxetine Hydrochloride
    Intervention: Drug: Atomoxetine Hydrochloride

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
267
September 2012
July 2012   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
6 Years to 17 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Canada,   Germany,   Hungary,   Italy,   Poland,   Spain,   Sweden,   United Kingdom,   United States
France
 
NCT01106430
SPD489-317
2009-011745-94 ( EudraCT Number )
No
Not Provided
Not Provided
Shire
Shire
Not Provided
Principal Investigator: Ralf W Dittmann, MD, PhD Dept of Child and Adolescent Psychiatry and Psychotherapy, Central Inst of Mental Health
Shire
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP