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Status:

WITHDRAWN

Event Rate and Effects of Stimulants in ADHD

Lead Sponsor:

University Ghent

Collaborating Sponsors:

Fund for Scientific Research, Flanders, Belgium

Shire

Conditions:

Attention Deficit Hyperactivity Disorder

Eligibility:

All Genders

7-12 years

Phase:

PHASE3

Brief Summary

Stimulants alleviate information processing and task performance deficits in Attention Deficit/Hyperactivity Disorder (ADHD). Long acting formulations of amphetamines such as lisdexamphetamine dimesyl...

Detailed Description

* Primary purpose: pathophysiology and basic science The aim of this study is to enlarge the knowledge of the mechanism action of long acting formulations of amphetamines and the neurobiological basis...

Eligibility Criteria

Inclusion

  • Children with ADHD (male and female)
  • Age: form 7 years old until the end of 12 years old at screening
  • Official diagnosis of ADHD (one of the three subtypes) as confirmed by administration of the Diagnostic Interview Scale for Children for DSM-IV (DISC-IV) interview at screening
  • No prior use of stimulant medication (Drug naïve)

Exclusion

  • Comorbid disorders (severe anxiety or mood disorder, Autism Spectrum Disorder, Conduct disorder, Tic disorder, other major psychiatric pathologies)
  • Other neurological disorder or chronic illness/disability
  • Intelligence quotient (IQ) below 80
  • Body weight below 22.7 kg
  • Use of a psychoactive medication (especially use of monoamine oxidase inhibitors (MAOI))
  • History of cardiac disease, family history of premature (sudden/unexpected) death in children or young adults, hypertrophic cardiomyopathy, clinically important arrhythmias including long QT syndrome (LQTS), Marfan syndrome
  • Abnormal findings on physical examination indicating cardiac disease
  • Glaucoma
  • Sensitive or allergic to stimulants or other ingredients of LDX

Key Trial Info

Start Date :

January 1 2014

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

January 1 2014

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT01913912

Start Date

January 1 2014

End Date

January 1 2014

Last Update

December 2 2021

Active Locations (2)

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Page 1 of 1 (2 locations)

1

Ghent University Hospital

Ghent, Belgium, 9000

2

Ghent University

Ghent, Belgium, 9000