Comparison of Lisdexamfetamine Dimesylate With Atomoxetine HCl in Attention-Deficit/Hyperactivity Disorder (ADHD) Subjects With an Inadequate Response to Methylphenidate
Status: | |
---|---|
Conditions: | Neurology, Psychiatric |
Therapuetic Areas: | Neurology, Psychiatry / Psychology |
Healthy: | No |
Age Range: | Any |
Updated: | 7/16/2012 |
Start Date: | June 2010 |
End Date: | January 2014 |
Contact: | Shire Call Center |
Phone: | +1-866-842-5335 |
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.
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.
We found this trial at
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