Kurzfassung

Any type of psychotherapeutical or pharmocological treatment of ADHD is embedded in psychoeducational methods as a basic support. A validated program for ADHD psychoeducation is the program of Prof. Döpfner ‘Wackelpeter und Trotzkopf’ (Döpfner et al., 2006, Kierfeld & Döpfner, 2006). Stimulants with their proven efficacy are only indicated when the symptoms are marked and psychoeducational support was without sufficient success during a couple of weeks (Stellungnahme „ADHS“-Langfassung...Any type of psychotherapeutical or pharmocological treatment of ADHD is embedded in psychoeducational methods as a basic support. A validated program for ADHD psychoeducation is the program of Prof. Döpfner ‘Wackelpeter und Trotzkopf’ (Döpfner et al., 2006, Kierfeld & Döpfner, 2006). Stimulants with their proven efficacy are only indicated when the symptoms are marked and psychoeducational support was without sufficient success during a couple of weeks (Stellungnahme „ADHS“-Langfassung der Bundesärztekammer vom 26.8.2005).
Due to ADHD practice parameters, during the weeks after a validated diagnosis primarily psychoeducational support is indicated. Afterwards an indication with a first choice pharmacological treatment (stimulant drug) or second choice (atomoxetine) and/ or psychotherapy may be considered. During the phase of psychoeducation, the additional application of a phytotherapeutic medication/ placebo or a nutritional supplement is ethically justified (“Add on”). In this case, the risk for the individual patient is minimized. This is the case in the proposed trial, because both treatment groups benefit from the psychoeducational treatment which may be considered as best supportive care. In addition, there might be an increased benefit by both verum and the placebo.
 
The trial objective has to be studied in humans, because of a lack of complex ADHD animal models covering core problems of the disorder. Etiologically, there is no single cause for ADHD. So far, the results of neuropsychological and neurobiological studies indicate, that deviations in the development of different central-nervous control cycles based on genetic and other factors are apparent. In particular, such neuronal systems which regulate attention, motor activity and impulsivitiy are impaired primarily in the dopaminergic and noradrenergic metabolism. Exogenic toxic factors, such as fetal nicotine exposure, cause higher risks for ADHD with similar neurobiological pathways. In addition, deviations of REM-sleep i.e. impaired sleep patterns are potential reasons for the development of ADHD.
Evidence indicates that PUFAs may play an important role in the prevention and treatment of certain mental health disorders (Bodnar and Wisner 2005, McNamara and Carlson 2006) like, for example, attention deficit hyperactivity disorder (ADHD). Several studies have been conducted, suggesting a link between omega-3/ omega-6 fatty acids on the one hand and ADHD symptoms and learning difficulties on the other (Stevens et al 1995). Trials with supplementation of a combination of two long-chained omega-3 acids, i.e. eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), in children with reading writing disorder (RWD), dyspraxia (i.e., motor coordination difficulties or developmental coordination disorder), and ADHD-related symptoms have reported significant symptom reductions (Stevens et al 2003, Richardson and Puri 2003, Richardson and Montgomery 2005).
The nutritional efficacy of PUFAs in combination with zinc and magnesium, in ADHD has to be examined according to scientific and ethical considerations. The nutritional efficacy has to be proven in agreement with the German Verordnung über Diätetische Lebensmittel (DiätV) and the corresponding European Directive 1999/21/EC. This objective is reached by performing a placebo-controlled supplementation study with a main efficacy criterion which is also being used in pivotal studies of stimulant and non-stimulant drugs, i.e. the treatment differences between final visit and baseline in the ADHDRS-IV-Parent Version (18-Item-Scale): Investigator Administered and Scored (ADHDRS-IV-Parent: Inv). This scale ranges from 0 to 54 points with a score of at least 24 points indicating the fulfilment of the diagnosis of ADHD according to DSM-IV. The biometrical planning is based on this primary efficacy criterion.


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