How to determine whether conceptual endophenotypes can improve clinical outcomes in patients suffering from major depression: An exploratory approach.

Depression is a complex mental health disorder, resulting in a high degree of disability. Since symptom constellation, course, and outcome are heterogeneous in these patients, current research initiatives are striving to establish stratified diagnostic and treatment approaches. In the past two decades, Dirk Hellhammer and his team introduced Neuropattern, a new diagnostic concept, which is based on conceptual endophenotypes of the stress response network. We explore how to use this concept in clinical practice in order to ultimately determine whether it brings any value over standard care. In view of the novelty of the concept and the difficulties dealing with such a concept at a practical level, it was necessary to initiate an exploratory study to determine key factors for planning future clinical trials. We report results and knowledge gained from an exploratory single-site study investigating the use and potential benefits of Neuropattern in standard care. Inpatients (ICD-10 diagnosis F32, F33; Nö=ö178) were allocated to either treatment as usual (standard group, SG) or a novel Neuropattern oriented exploratory treatment (intervention group, IG). Symptom severity was assessed with psychometric tests at admission to hospital, during the first six weeks, and upon discharge from the hospital. In addition, direct and indirect costs were assessed for the 3-month-intervals prior to and after the hospital stay. Compared to the SG, depression scores of patients in the IG showed a faster decline once psychotherapeutic and pharmacological treatment were based on an individualized explanatory model. The patients in the IG with an F33 diagnosis showed a more pronounced reduction of depression severity during the stay in the hospital and a stronger and quicker reduction of general symptom severity. Comparing the average depression scores at the start of the study and after six weeks, symptom severity was reduced in all Neuropattern groups. Some limitations of the study have to be mentioned: The study was not blinded, was single-site, included highly depressed inpatients only, and was conducted for no longer than 8 months. The results highlight some important issues regarding taking the Neuropattern approach to the bedside and researching its efficacy and effectiveness to support personalized treatments in clinical care.