Attention Deficit Hyperactivity Disorder Drugs Use Chronic Effects
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- NHS Tayside
- Enrollment
- 1,398
- Locations
- 4
- Primary Endpoint
- The height velocity standard deviation score
Study Overview
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 period in children and adults.
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 5 Years to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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 Criteria
- •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.
- •Parent rated SDQ Hyperactivity Score in Borderline or Abnormal range.
Outcomes
Primary Outcomes
The height velocity standard deviation score
Time Frame: 2 years
Child's height velocity-mean height velocity for sex and age / Standard deviation of height velocity for sex and age.
Secondary Outcomes
- Changes to the cardiovascular system(2 years)
- Effects on Psychiatric state(2 years)
- Changes in growth(2 years)
- Changes in neurological state(2 years)
Investigators
Sarah Inglis
Trial Manager
University of Dundee