Attention Deficit Hyperactivity Disorder (ADHD)ADDUCENCT01470261
Attention Deficit Hyperactivity Disorder Drugs Use Chronic Effects
An observational study of Attention Deficit Hyperactivity Disorder (ADHD), run by NHS Tayside at 4 sites in 4 countries.
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. Read more about this study
- Who is it for?
- Ages 5 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder (ADHD)
- Type of treatment
- Injection or infusion
- How many people
- 1,398 participants
- Where
- 4 sitesin 4 countries
- Study dates
- Feb 2012to Apr 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Attention Deficit Disorder clinic
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
Hungary1 site
Vadaskert Child and Adolescent Psychiatry Hospital and Outpatient Clinic
Budapest
About this study
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.
Read the 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.
- Keywords
- methylphenidate, ritalin, Attention Deficit Disorder
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (4)
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)
Measured: 2 years
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
Measured: 2 years
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
Measured: 2 years
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)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2011 (estimated)
- Study startFeb 2012
- Primary completionJan 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Hyperactivity Disorder (ADHD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,398 participants (actual)
Sponsor and investigators
- Lead sponsor
- NHS Tayside
- Sponsor type
- Other government
- Collaborators
- Zentralinstitut für Seelische Gesundheit Mannheim, Universita degli Studi di Cagliari, Vadaskert Child and Adolescent Psychiatric Hospital
- Responsible party
- Principal investigator, Sarah Inglis, University of Dundee
- Investigators
- David Coghill, ', Principal investigator, University of Dundee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01470261
- Sponsor's protocol ID
- 2011PW02
- Acronym
- ADDUCE
- Status last verified
- Sep 2016
- First submitted
- 9 Nov 2011
- Last updated
- 21 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 27118284
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Attention Deficit Hyperactivity Disorder Drugs Use Chronic Effects
- ClinicalTrials.gov ID
- NCT01470261
- Acronym / sponsor ID
- ADDUCE / 2011PW02
- Keywords
- methylphenidate, ritalin, Attention Deficit Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,398 participants (actual)
- Lead sponsor
- NHS TaysideOther government
- Collaborators
- Zentralinstitut für Seelische Gesundheit Mannheim, Universita degli Studi di Cagliari, Vadaskert Child and Adolescent Psychiatric Hospital
- Study start
- Feb 2012
- Primary completion
- Jan 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 11 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Attention Deficit Disorder clinic
Key inclusion criteria (21 listed)
- 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.
Key exclusion criteria (7 listed)
- Current or past treatment with dexamfetamine or atomoxetine.
- Previous or current treatment with methylphenidate.
- Previous or current treatment with methylphenidate.
- Clinician rated SNAP score ≥ 1.5. Parent rated SDQ Hyperactivity Score in Borderline or Abnormal range.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
4 secondary outcomes
Changes in growth
Time frame: 2 years
Changes to the cardiovascular system
Time frame: 2 years
Effects on Psychiatric state
Time frame: 2 years
Changes in neurological state
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2016.
- Derived from this study: PubMed 27118284Inglis 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.
- Study websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Coghill, ' principal investigator
University of Dundee
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Attention Deficit Hyperactivity Disorder (ADHD), run by NHS Tayside at 4 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany, Hungary, Italy, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The height velocity standard deviation score (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01470261, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2016.