NCT01470261

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,398

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2012

Longer than P75 for all trials

Geographic Reach
4 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 9, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 11, 2011

Completed
3 months until next milestone

Study Start

First participant enrolled

February 1, 2012

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

September 21, 2016

Status Verified

September 1, 2016

Enrollment Period

3.9 years

First QC Date

November 9, 2011

Last Update Submit

September 20, 2016

Conditions

Attention Deficit Hyperactivity Disorder (ADHD)

Keywords

methylphenidateritalinAttention Deficit Disorder

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (4)

  • Changes in growth

    2 years

  • Changes to the cardiovascular system

    2 years

  • Effects on Psychiatric state

    2 years

  • Changes in neurological state

    2 years

Study Arms (3)

ADHD medicated

Children aged 5-17 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 5-17 years with clinical diagnosis and not previously treated with methylphenidate who have an agreement with their physician NOT to treat with methylphenidate

Non-ADHD controls

Any child, including siblings of a child in either the ADHD-medicated or ADHD-unmedicated control group, who is 5-17 years old. 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.

Eligibility Criteria

Age5 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Attention Deficit Disorder clinic

You may qualify if:

  • 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.
  • +6 more criteria

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Zentralinstitut fuer seelische gesundheit

Mannheim, Stadtkreis, Germany

Location

Vadaskert Child and Adolescent Psychiatry Hospital and Outpatient Clinic

Budapest, Hungary

Location

Universita degli Studi di Cagliari

Cagliari, Sardinia, Italy

Location

University of Dundee

Dundee, Tayside, DD1 9SY, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 27118284DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Officials

  • David Coghill, '

    University of Dundee

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Trial Manager

Study Record Dates

First Submitted

November 9, 2011

First Posted

November 11, 2011

Study Start

February 1, 2012

Primary Completion

January 1, 2016

Study Completion

April 1, 2016

Last Updated

September 21, 2016

Record last verified: 2016-09

Locations

IT(1)GB(1)HU(1)DE(1)