Brandeis D. EU - Europäische Union 684809: NEWROFEED - für Kinder und Jugendlichen mit einer AD(H)S. 09/2016-10/2017.
Die Aufmerksamkeitsdefizit-/Hyperaktivitätsstörung (ADHS) ist eine der häufigsten psychischen Erkrankungen bei Kindern und Jugendlichen. Obwohl es gute Möglichkeiten der psychotherapeutischen und medikamentösen Behandlung gibt, besteht eine große Nachfrage nach alternativen und ergänzenden Therapiemethoden. Neurofeedback ist ein neueres nichtmedikamentöses therapeutisches Verfahren, bei dem Patienten lernen können, die elektrische Aktivität ihres Gehirns gezielt zu regulieren. Die NEWROFEED-Studie untersucht erstmals die Wirksamkeit eines personalisierten Neurofeedback-Trainingsgeräts für den Heimgebrauch (ADHD@Home) im Vergleich mit medikamentöser Therapie bei der Behandlung von Kindern und Jugendlichen mit ADHS (7–13 Jahre). Nach einer ausführlichen Diagnostik werden die Teilnehmer nach dem Zufallsprinzip in einem Verhältnis von 3:2 einer Neurofeedback-Behandlung oder einer medikamentösen Behandlung mit dem Wirkstoff Methylphenidat zugeteilt. Die Teilnehmer der Medikamenten-Gruppe erhalten eine individuelle medikamentöse Einstellung und Behandlung durch einen erfahrenen Kinder-und Jugendpsychiater. Die Teilnehmer der Neurofeedback-Gruppe und deren Eltern werden ausführlich in die Nutzung des Neurofeedback-Trainingsgerätes eingewiesen und führen anschließend das Neurofeedback-Training zuhause auf einem Tablet-Computer durch. Das Training umfasst 40 Sitzungen von jeweils 45 Minuten. Dabei wird die Hirnaktivität im Rahmen kleiner Spiele in Echtzeit zurückgemeldet. Die Dauer der Studienteilnahme beträgt insgesamt circa 3 Monate. Ziel der Studie ist nachzuweisen, dass das personalisierte Neurofeedbacktraining einer sorgfältigen medikamentösen Behandlung in der Wirksamkeit nicht unterlegen ist.
Dittmann RW. EU - Europäische Union 278948: TACTICS: Translational Adolescent and Childhood Therapeutic Interventions in Compulsive Syndromes.
Compulsivity is characterized by a repetitive, irresistible urge to perform a behavior, the experience of loss of voluntary control over this intense urge, the diminished ability to delay or inhibit thoughts or behaviors, and the tendency to perform repetitive acts in a habitual or stereotyped manner. Compulsivity is a cross-disorder trait underlying phenotypically distinct psychiatric disorders that emerge in childhood (autism spectrum disorder, ASD; obsessive-compulsive disorder, OCD) or adolescence (substance abuse). Our approach integrates clinical data sets for ‘addictive’ (ADHD high risk for substance use), ‘anxious’ (OCD) and ‘stereotypical’ (ASD) compulsive behaviors with highly predictive animal models for new pharmacotherapy. In a series of ‘proof-of-concept’ studies, the cohesion of structural neuroimaging studies (MRI/DTI), neurochemistry (MRS/microdialysis), behavior, genetics (GWAS), proteomics and (Bayesian) machine learning tools in both male and female paediatric clinical populations and behavioral animal models will seek to better understand underlying mechanisms related to glutamate dysfunction in frontostriatal circuits and its remediation / prevention by early intervention studies with glutamate-based (riluzole and memantine) clinically used drugs. The leading drug-based interventions will be tested in pilot Phase IIb-like studies for ‘proof-of-principle’ efficacy in paediatric OCD and ASD populations.
This approach will
1) establish predictive neural, genetic and molecular markers of compulsivity in pediatric populations;
2) provide evidence of disorder modifying pharmacologic strategies as a therapeutic approach;
3) develop a novel animal model for pharmaceutical screening and proof of concept
studies,
4) build and valorize a translational biomarker compulsivity database and
5) provide pilot efficacy and safety data in paediatric clinical populations to support future large scale clinical trials according to these strategies.
Dittmann RW. EU - Europäische Union 241959: PERS: Paediatric European Risperidone Studies.
The PERS project addresses major gaps in the evidence-base of the use of risperidone for the treatment of conduct disorder in children and adolescents. PERS proposes 3 clinical studies that will provide information on efficacy and tolerability for the use of risperidone in children and adolescents with conduct disorder and long term safety of risperidone in children and adolescents receiving risperidone for a variety of conditions.
Dittmann RW. EU - Europäische Union 261411: STOP: Suicidality: Treatment Occurring in Paediatrics.
The emergence of suicidality in patients receiving drug treatment is of concern because of the overall burden
and the possible link with completed suicide. The lack of uniform requirements for defining, detecting and
recording suicidality and the presence of disease related confounders create major problems. It is possible
that Medication-Related Suicidality (MRS) differs from Psychopathology-Related Suicidality (PRS) in terms of
phenomenology, clinical expression and time course, and may vary between children and adults. Unlike PRS,
the time-course of MRS may be associated with possible differences in drug pharmacokinetics; abrupt onset;
absence of suicidality prior to start of medication; and emergence of suicidality related co-morbidities after
treatment.
This project will focuses on developing a web-based comprehensive methodology for the assessment and
monitoring of suicidality and its mediators in children and adolescents using the HealthTrackerTM (a paediatric
web-based health outcome monitoring system), with the aim of developing a Suicidality Assessment and
Monitoring Module, a Bio-psycho-social Mediators of Suicidality Assessment Module, and a Suicidality-Related
Psychiatric and Physical Illness Module. The information obtained will be used to computer-generate
classification of suicidality using the Classification of Suicide-Related Thoughts and Behaviour (Silverman et
al, 2007) and the Columbia Classification Algorithm of Suicidal Assessment (C-CASA) (Posner et al, 2007).
The existing Medication Characteristics Module will be expanded to allow documentation of pharmacological
characteristics of medication, to explore whether they mediate MRS. The methodology will then be tested in
3 paediatric observational trials (risperidone in conduct disorder; fluoxetine in depression, and montelukast
in bronchial asthma) and standardized, which can be used pharmacovigilance and in epidemiological,
observational, and registration trials.
Dittmann RW, Banaschewski T. BMBF - Bundesministerium für Bildung und Forschung 01KG0914: Klinische Prüfung DEMIJO BMBF Johanniskraut (SJW) bei leichter bis mittelschwerer Depression (MDD) bei Jugendlichen.
Mit der Johanniskraut-Studie soll die Wirksamkeit des pflanzlichen Arzneimittels Johanniskraut bei Jugendlichen mit Depressionen überprüft werden.
Banaschewski T. EU - Europäische Union 728018: Eat2beNice.
The project's goal is to identify nutrition and lifestyle drivers that can be employed to prevent detrimental impulsivity/compulsivity in humans across the lifespan. The project aims to characterize the etiologic paths leading to extreme behaviour and promote policy changes to counteract maladaptive impulsivity/compulsivity by disseminating evidence-based information about health-related behaviours to families, clinicians, policy makers and the general public.
Banaschewski T. EU - Europäische Union 260576: ADDUCE: Attention Deficit Hyperactivity Disorder Drugs Use Chronic Effects.
Attention deficit hyperactivity disorder (ADHD) is one of the most common neurodevelopmental disorders in children, affecting approximately 5% children in Europe. Methylphenidate (MPH) 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. The ADDUCE team will use multiple pharmaco-epidemiological research methods to achieve its aim:
(1) Retrospective analysis of existing databases.
(2) 2-year prospective cohort study recruiting 800 MPH-treated children and adolescents and 800 controls.
(3) Cross-sectional study (600 MPH-treated patients and 600 controls) in late adolescents and young adults.
Furthermore the ADDUCE team will develop research tools for the evaluation of adverse effects of MPH on cognition and motivation.
The ADDUCE consortium comprises 12 academic partners, 1 SME and 1 EU professional network.
The ADDUCE team will directly interact with the European Medicines Agency to assist them in making regulatory decisions on the safety of MPH in children and adults.
The ADDUCE team will adopt an open-access policy to ensure the information and results have the maximum public health impact.