Clinical trial NCT01470261: Attention Deficit Hyperactivity Disorder Drugs Use Chronic Effects
Official title: Attention Deficit Hyperactivity Disorder Drugs Use Chronic Effects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Attention Deficit Hyperactivity Disorder (ADHD)
Keywords: methylphenidate
ritalin
Attention Deficit Disorder
Lead sponsor: NHS Tayside
Sponsor class: OTHER_GOV
Collaborators: name: Zentralinstitut für Seelische Gesundheit Mannheim
name: Universita degli Studi di Cagliari
name: Vadaskert Child and Adolescent Psychiatric Hospital
First posted: 2011-11-11
Enrollment: 1398
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Attention Deficit Disorder clinic

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.

Eligibility criteria: 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 ≥ 1.5. Parent rated SDQ Hyperactivity Score in Borderline or Abnormal range.

Primary outcomes:
measure: The height velocity standard deviation score
timeFrame: 2 years
Secondary outcomes:
measure: Changes in growth
timeFrame: 2 years
measure: Changes to the cardiovascular system
timeFrame: 2 years
measure: Effects on Psychiatric state
timeFrame: 2 years
measure: Changes in neurological state
timeFrame: 2 years
Other outcomes:
Locations:
city: Mannheim
country: Germany
facility: Zentralinstitut fuer seelische gesundheit
state: Stadtkreis
city: Budapest
country: Hungary
facility: Vadaskert Child and Adolescent Psychiatry Hospital and Outpatient Clinic
city: Cagliari
country: Italy
facility: Universita degli Studi di Cagliari
state: Sardegna
city: Dundee
country: United Kingdom
facility: University of Dundee
state: Tayside
Study officials:
affiliation: University of Dundee
name: David Coghill, '
role: PRINCIPAL_INVESTIGATOR
References:
citation: Inglis SK, Carucci S, Garas P, Hage A, Banaschewski T, Buitelaar JK, Dittmann RW, Falissard B, Hollis C, Kovshoff H, Liddle E, McCarthy S, Nagy P, Neubert A, Rosenthal E, Sonuga-Barke E, Wong I, Zuddas A, Coghill DC; ADDUCE Consortium. Prospective observational study protocol to investigate long-term adverse effects of methylphenidate in children and adolescents with ADHD: the Attention Deficit Hyperactivity Disorder Drugs Use Chronic Effects (ADDUCE) study. BMJ Open. 2016 Apr 26;6(4):e010433. doi: 10.1136/bmjopen-2015-010433.