Attention Deficit Hyperactivity Disorder Drugs Use Chronic Effects (ADDUCE)

This study is currently recruiting participants.
Verified February 2012 by NHS Tayside
Sponsor:
Collaborators:
Zentralinstitut fuer Seelische Gesundheit
Universita degli Studi di Cagliari
Vadaskert Child and Adolescent Psychiatry Clinic
Information provided by (Responsible Party):
Sarah Inglis, University of Dundee
ClinicalTrials.gov Identifier:
NCT01470261
First received: November 9, 2011
Last updated: February 8, 2012
Last verified: February 2012
  Purpose

The aim of the ADDUCE project is to investigate any adverse effects of methylphenidate (trade name ritalin) on growth, neurological system, psychiatric states and cardiovascular system over a two year period in children and adults.


Condition
Attention Deficit Hyperactivity Disorder (ADHD)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Attention Deficit Hyperactivity Disorder Drugs Use Chronic Effects

Resource links provided by NLM:


Further study details as provided by NHS Tayside:

Primary Outcome Measures:
  • The height velocity standard deviation score [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    Child's height velocity-mean height velocity for sex and age / Standard deviation of height velocity for sex and age.


Secondary Outcome Measures:
  • Changes in growth [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    • Proportion height < 2nd centile, 0.4th centile (according to best available country specific norms)
    • Weight (z-scores according to best available country specific norms)
    • Proportion weight < 2nd centile, 0.4th centile (according to best available country specific norms)
    • BMI (z-scores according to best available country specific norms)
    • Proportion BMI < 2nd centile, 0.4th centile (according to best available country specific norms)
    • Pubertal stage (Tanner stage)
    • Bone age (selected sample from Italian cohort)

  • Changes to the cardiovascular system [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    • Heart rate
    • Proportion heart rate > 120 bpm
    • Diastolic blood pressure
    • Proportion diastolic blood pressure > 90 mm/hg
    • Systolic blood pressure
    • Proportion systolic blood pressure > 95th centile

  • Effects on Psychiatric state [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    • SNAP-IV mean scores
    • Clinical Global Impressions score(CGI; severity, improvement)
    • Children's Global Assessment Scale score (CGAS)
    • Strengths and Difficulties questionnaire (SDQ)
    • Mood and Feelings Scale (parent and child ratings)
    • Developmental and Wellbeing Assessment
    • DAWBA Rapidly changing mood section (proportion > cut off)
    • DAWBA tics section (proportion > cut off)
    • Columbia - Suicide Severity Rating Scale
    • Psychosis-like symptoms
    • Substance Use Questionnaire

  • Changes in neurological state [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    • Child's Sleep Habits Questionnaire (CSHQ; total score and subscale scores, proportion > cut offs)
    • Abnormal Involuntary Movement Scale (AIMS; total score, Q8 score)


Estimated Enrollment: 1600
Study Start Date: November 2011
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
ADHD medicated
Children aged 6-17 years with clinical diagnosis of ADHD and not previously treated with methylphenidate who have an agreement with their physician to begin treatment with methylphenidate.
ADHD unmedicated controls
Children aged between 6-17 years with clinical diagnosis and not previously treated with methylphenidate who have an agreement with their physician NOT to treat with methylphenidate
Non-ADHD siblings controls
Siblings of a child in either the ADHD-medicated or ADHD-unmedicated control group who are 6-17 years old and living in the same family as the child with ADHD. These children must have a low rating (<1.5) on the clinician-rated Swanson Nolan and Pelham IV Rating scale (SNAP IV) and not be medicated with with either dexamfetamine or atomoxetine.

Detailed Description:

Attention deficit hyperactivity disorder (ADHD) is one of the most common neurodevelopmental disorders in children, affecting approximately 5% children in Europe. Methylphenidate (MPH, trade name ritalin) is the most-commonly prescribed medication for ADHD children; it is also increasingly used in ADHD adults. In 2007, the European Commission requested a referral to the Committee for Medicinal Products for Human Use (CHMP) under Article 31 of Directive 2001/83/EC, as amended, for MPH because of safety concerns. The CHMP concluded that study of the long-term effects of MPH on growth, sexual development, neurological system, psychiatric states and cardiovascular system is needed. In response to the CHMP s concerns, the ADDUCE (Attention Deficit Hyperactivity Disorder Drugs Use Chronic Effects) research team has been formed by a consortium of experts in the fields of ADHD, drug safety, neuro-psychopharmacology and cardiovascular research.

The ADDUCE project aims to investigate the long-term adverse effects of MPH on growth, neurological system, psychiatric states and cardiovascular system in children and adults.

Furthermore the ADDUCE team will develop research tools for the evaluation of adverse effects of MPH on cognition and motivation.

  Eligibility

Ages Eligible for Study:   6 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Attention Deficit Disorder clinic

Criteria

Inclusion Criteria:

ADHD-treated group:

  • Clinical diagnosis of ADHD
  • Aged between 6 and 17 years.
  • Not previously treated with methylphenidate
  • Agreement between clinician, patient and their family to commence on methylphenidate (baseline measures will be taken before first prescription of methylphenidate is issued).
  • Any co-medication other than dexamfetamine or atomoxetine will be allowed.
  • All psychiatric and physical illness comorbidities will be allowed

ADHD-unmedicated controls:

  • Clinical diagnosis of ADHD not previously treated with medication.
  • Aged between 6 and 17 years.
  • Agreement between clinician, patient and their family not to treat with methylphenidate.
  • Any medication other than dexamfetamine or atomoxetine will be allowed.
  • All comorbidities will be allowed.

Non-ADHD siblings controls:

  • Sibling of a member of the two ADHD groups (medicated or unmedicated).
  • Living in the same family as the proband.
  • Aged between 6 and 17 years.
  • Mean total clinician rated Swanson Nolan and Pelham IV Rating scale (SNAP IV) score (ADHD items) < 1.5
  • Parent rated Strengths and Difficulties Questionnaire (SDQ) Hyperactivity Score within normal range for country (e.g. < 6 for UK)
  • Any current medication other than dexamfetamine or atomoxetine will be allowed.
  • Any other mental health or physical illness diagnoses will be allowed.

Exclusion Criteria:

All Groups:

  • Current or past treatment with dexamfetamine or atomoxetine.

Un-medicated ADHD controls:

  • Previous or current treatment with methylphenidate.

Non-ADHD Siblings controls:

  • Previous or current treatment with methylphenidate.
  • Clinician rated SNAP score ≥ 1.5. Parent rated SDQ Hyperactivity Score in Borderline or Abnormal range.
  • Living in a different home to index case.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01470261

Locations
Germany
Zentralinstitut fuer seelische gesundheit Not yet recruiting
Mannheim, Stadtkreis, Germany
Contact: Tobias Banaschewski, MD PhD       beate.rothacker@zi-mannheim.de   
Principal Investigator: Tobias Banaschewski, MD PhD         
Hungary
Vadaskert Child and Adolescent Psychiatry Hospital and Outpatient Clinic Not yet recruiting
Budapest, Hungary
Contact: Julia Gadoros, MD PhD       gadoros@vadasnet.hu   
Principal Investigator: Julia Godoros, MD PhD         
Italy
Universita degli Studi di Cagliari Not yet recruiting
Cagliari, Sardegna, Italy
Contact: Alessandro Zuddas       azuddas@unica.it   
Principal Investigator: Alessandro Zuddas         
United Kingdom
University of Dundee Recruiting
Dundee, Tayside, United Kingdom, DD1 9SY
Contact: Sarah K Inglis, PhD    +44 1382 740134    s.k.inglis@dundee.ac.uk   
Principal Investigator: David Coghill         
Sponsors and Collaborators
NHS Tayside
Zentralinstitut fuer Seelische Gesundheit
Universita degli Studi di Cagliari
Vadaskert Child and Adolescent Psychiatry Clinic
Investigators
Principal Investigator: David Coghill, ` University of Dundee
  More Information

Additional Information:
No publications provided

Responsible Party: Sarah Inglis, Trial Manager, University of Dundee
ClinicalTrials.gov Identifier: NCT01470261     History of Changes
Other Study ID Numbers: 2011PW02
Study First Received: November 9, 2011
Last Updated: February 8, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by NHS Tayside:
methylphenidate
ritalin
Attention Deficit Disorder

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
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

ClinicalTrials.gov processed this record on April 15, 2014