Attention Deficit Hyperactivity Disorder (ADHD) Clinical Trial
Official title:
Attention Deficit Hyperactivity Disorder Drugs Use Chronic Effects
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.
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.
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Observational Model: Cohort, Time Perspective: Prospective
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03260205 -
Safety and Efficacy Study in Preschool Children Aged 4-5 Years With Attention-deficit/Hyperactivity Disorder (ADHD)
|
Phase 3 | |
| Withdrawn |
NCT03546400 -
Safety, Tolerability and PK Study of Methylphenidate HCl ERCT in 4-5 Year Old Children With ADHD.
|
Phase 4 | |
| Completed |
NCT02917109 -
LearningRx Cognitive Training for ADHD
|
N/A | |
| Completed |
NCT02248948 -
Superiority of Omega-3 Versus Placebo on the Improvement of ADHD in Children
|
N/A | |
| Recruiting |
NCT01750307 -
The Relationship of Essential Fatty Acids to Adult ADHD: The OCEAN Study (Oils and Cognitive Effects in Adult ADHD Neurodevelopment)
|
N/A | |
| Recruiting |
NCT06170996 -
Internet-Assisted Behavioral Parent Training Intervention for Children With Attention Deficit Hyperactivity Disorder
|
N/A | |
| Completed |
NCT00735371 -
Efficacy and Safety of Lisdexamfetamine Dimesylate (LDX) in Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD)
|
Phase 3 | |
| Withdrawn |
NCT03580005 -
A 6-week Study to Evaluate the Safety and Efficacy of Quillichew ERCT in 4-5 Year Old Children With ADHD.
|
Phase 4 | |
| Completed |
NCT02578030 -
Pharmacokinetic Study in Children and Adolescents Aged 6 to 17 Years Who Have Been Diagnosed With ADHD
|
Phase 1 | |
| Completed |
NCT02574273 -
Pilot Trial of a Social Skills Group Treatment (Secret Agent Society Program)
|
N/A | |
| Completed |
NCT02257216 -
Vayarin® Medical Food Study for Adults With Attention Deficit Hyperactivity Disorder (ADHD)
|
N/A | |
| Recruiting |
NCT04943796 -
A Study to Learn About the Occurrence of ADHD in Adults With Mental Conditions and Their Quality of Life
|
||
| Recruiting |
NCT04634006 -
Home-Based tDCS in Children With ADHD: A Randomized, Sham-Controlled tDCS and fNIRS Study
|
N/A | |
| Active, not recruiting |
NCT02908802 -
Probiotic Supplement as Treatment for Students With ADHD
|
N/A | |
| Completed |
NCT02604407 -
Safety and Efficacy Study of SHP465 in Adults Aged 18-55 Years With Attention-deficit/ Hyperactivity Disorder (ADHD)
|
Phase 3 | |
| Completed |
NCT05870605 -
Drug Use Study With Intuniv® in European Countries
|
||
| Terminated |
NCT03481959 -
Effectiveness of Methylphenidate Late Formula to Reduce Cannabis Use in Young Cannabis-Related Patients and Attention Deficit Disorder Hyperactivity
|
Phase 3 | |
| Terminated |
NCT03638466 -
Exploratory fMRI Study on the Treatment for Impulsive Aggression in Children With Attention-Deficit/Hyperactivity Disorder
|
Phase 2 | |
| Completed |
NCT03709940 -
Brain Connectivity in Attention Deficit Hyperactivity Disorder (ADHD)
|
N/A | |
| Completed |
NCT02795637 -
Study of the What the Body Does to the Drug in Subjects With Mild, Moderate, and Severe Liver Dysfunction
|
Phase 1 |