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

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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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:

MedlinePlus related topics: Attention Deficit Hyperactivity Disorder

Drug Information available for: Methylphenidate Methylphenidate hydrochloride Atomoxetine hydrochloride Atomoxetine Lisdexamfetamine Lisdexamfetamine dimesylate

U.S. FDA Resources

Further study details as provided by Shire Development LLC:

Primary Outcome Measures:

Clinical Global Impression-Improvement (CGI-I) Score [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
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.

Secondary Outcome Measures:

ADHD-Rating Scale-IV [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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.

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

Ages Eligible for Study:	6 Years to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subject has had an historical or current inadequate response to 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01106430

Show 64 Study Locations

Sponsors and Collaborators

Shire Development LLC

Investigators

Principal Investigator:

Ralf W Dittmann, MD, PhD

Dept of Child and Adolescent Psychiatry and Psychotherapy, Central Inst of Mental Health

More Information

No publications provided

Responsible Party:	Shire Development LLC
ClinicalTrials.gov Identifier:	NCT01106430 History of Changes
Other Study ID Numbers:	SPD489-317
Study First Received:	April 14, 2010
Last Updated:	January 25, 2013
Health Authority:	United States: Food and Drug Administration Canada: Health Canada Canada: Ethics Review Committee Belgium: Federal Agency for Medicinal Products and Health Products France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Germany: Ministry of Health Italy: National Monitoring Centre for Clinical Trials - Ministry of Health The Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) Spain: Spanish Agency of Medicines Sweden: Medical Products Agency United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Shire Development LLC:

ADHD

Additional relevant MeSH terms:

Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Methylphenidate
Dextroamphetamine
Atomoxetine

Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses
Adrenergic Uptake Inhibitors
Adrenergic Agents

ClinicalTrials.gov processed this record on May 21, 2013