Dittmann RW. EU - Europäische Union 278948: TACTICS: Translational Adolescent and Childhood Therapeutic Interventions in Compulsive Syndromes. 01/2012-12/2016.
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. 05/2010-04/2015.
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. 11/2010-04/2014.
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. 10/2009-06/2013.
Mit der Johanniskraut-Studie soll die Wirksamkeit des pflanzlichen Arzneimittels Johanniskraut bei Jugendlichen mit Depressionen überprüft werden.