Status:
COMPLETED
Attention Deficit Hyperactivity Disorder Drugs Use Chronic Effects
Lead Sponsor:
NHS Tayside
Collaborating Sponsors:
Zentralinstitut für Seelische Gesundheit Mannheim
Universita degli Studi di Cagliari
Conditions:
Attention Deficit Hyperactivity Disorder (ADHD)
Eligibility:
All Genders
5-17 years
Brief Summary
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...
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 rita...
Eligibility Criteria
Inclusion
- ADHD-treated group:
- Clinical diagnosis of ADHD
- Aged between 5 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 5 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 controls:
- Child who does not have ADHD.
- Aged between 5 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.
- Must never have taken methylphenidate
- Any other mental health or physical illness diagnoses will be allowed.
Exclusion
- All Groups:
- Current or past treatment with dexamfetamine or atomoxetine.
- Un-medicated ADHD controls:
- Previous or current treatment with methylphenidate.
- Non-ADHD controls:
- Previous or current treatment with methylphenidate.
- Clinician rated SNAP score ≥ 1.5. Parent rated SDQ Hyperactivity Score in Borderline or Abnormal range.
Key Trial Info
Start Date :
February 1 2012
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2016
Estimated Enrollment :
1398 Patients enrolled
Trial Details
Trial ID
NCT01470261
Start Date
February 1 2012
End Date
April 1 2016
Last Update
September 21 2016
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Zentralinstitut fuer seelische gesundheit
Mannheim, Stadtkreis, Germany
2
Vadaskert Child and Adolescent Psychiatry Hospital and Outpatient Clinic
Budapest, Hungary
3
Universita degli Studi di Cagliari
Cagliari, Sardinia, Italy
4
University of Dundee
Dundee, Tayside, United Kingdom, DD1 9SY