Attention Deficit Hyperactivity Disorder Drugs Use Chronic Effects

Attention Deficit Hyperactivity Disorder (ADHD) Clinical Trial

— ADDUCE  

Official title:

Attention Deficit Hyperactivity Disorder Drugs Use Chronic Effects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01470261
• Other study ID #: 2011PW02
• Status: Completed
• Phase: N/A
• First received: November 9, 2011
• Last updated: September 20, 2016
• Start date: February 2012
• Est. completion date: April 2016

Study information

• Verified date: September 2016
• Source: NHS Tayside
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1398
• Est. completion date: April 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 5 Years to 17 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder (ADHD)
• Disease
• Hyperkinesis

Locations

Country	Name	City	State
Germany	Zentralinstitut fuer seelische gesundheit	Mannheim	Stadtkreis
Hungary	Vadaskert Child and Adolescent Psychiatry Hospital and Outpatient Clinic	Budapest
Italy	Universita degli Studi di Cagliari	Cagliari	Sardegna
United Kingdom	University of Dundee	Dundee	Tayside

Sponsors (4)

Lead Sponsor	Collaborator
NHS Tayside	Universita degli Studi di Cagliari, Vadaskert Child and Adolescent Psychiatric Hospital, Zentralinstitut für Seelische Gesundheit Mannheim

Countries where clinical trial is conducted

Germany,  Hungary,  Italy,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The height velocity standard deviation score	Child's height velocity-mean height velocity for sex and age / Standard deviation of height velocity for sex and age.	2 years	Yes
Secondary	Changes in growth	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)	2 years	Yes
Secondary	Changes to the cardiovascular system	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	2 years	Yes
Secondary	Effects on Psychiatric state	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	2 years	Yes
Secondary	Changes in neurological state	Child's Sleep Habits Questionnaire (CSHQ; total score and subscale scores, proportion > cut offs); Abnormal Involuntary Movement Scale (AIMS; total score, Q8 score)	2 years	Yes

External Links

•   Study website