BKH Augsburg
BKH Augsburg


Within our clinical trial group, we currently focus on two main areas: on the one hand, we are intensively engaged in the further development of treatment offers for people with schizophrenia spectrum disorders. On the other hand, we concern ourselves intensively with the further development of non-invasive stimulation methods (especially transcranial magnetic stimulation, rTMS) for people with persistent auditory hallucinations as well as depressive disorders. Participants are accompanied by our specially trained treatment team in an inpatient or outpatient setting. The well-being and safety of our study participants are our top priorities in accordance with the guidelines of Good Clinical Practice (GCP).


Following clinical trials are currently conducted as IIT under our direction


EARLY (Effects of early application of clozapine on remission rates in acute schizophrenia; DFG-funded)
The currently valid treatment guidelines for treating schizophrenia recommend the use of clozapine in cases of treatment resistance, i.e., when conventional antipsychotics of two different substance classes could not achieve sufficient therapeutic effects. However, there are scientific studies in patients with schizophrenia implicating that an early use of clozapine as a treatment option in patients with schizophrenia results in an earlier onset of remission (remission = lessening of symptoms of illness) and a higher remission rate. But so far, this has not been studied in clinical trials. Our clinical trial is investigating whether early use of clozapine at a stage of disease when treatment resistance has not yet set in will result in a better disease outcome than olanzapine as one of the most effective antipsychotics in schizophrenia treatment. Study participants will be treated with either clozapine or olanzapine for a period of 8 weeks while being accompanied by our specially trained treatment team. Further objectives of the study are to examine differences in side effects, symptom severity, safety, and cognitive function among participants.


TARGET Flame (BMBF-funded as part of an European consortium)

There is numerous evidence that immune dysfunction, and in particular inflammation, is associated with schizophrenia. Despite frequent references indicating that inflammation of nervous tissue contributes to the symptoms of schizophrenia, the underlying mechanisms have only been rudimentarily explored so far. Several studies indicate an association between low-grade inflammation of nervous tissue and increased production of factors damaging the nervous system. Overall, data suggest that these factors may have a direct or indirect effect on neurons and may trigger or exacerbate symptoms. Thus, if inflammation contributes to the symptoms of schizophrenia, treatment with additional anti-inflammatory drugs should improve clinical outcomes. Such a hypothesis has been tested in clinical trials administering steroids or nonsteroidal anti-inflammatory drugs, including certain anti-inflammatory drugs such as celecoxib and statins as an additional therapy. However, the results were inconsistent. None of the studies used a precision medicine approach to detect and select patients with an inflammatory blood profile. Therefore, in the Target Flame study, the clinical benefit of adding the anti-inflammatory drug celecoxib to treatment for a period of 8 weeks was assessed in a subset of schizophrenia patients with inflamed blood profiles (pro-inflammatory phenotype). A randomized, double-blind, phase III clinical trial in prospectively enrolled patients with schizophrenia will be conducted to further examine and better understand the underlying associations.


We are currently conducting the following clinical trials under the direction of other university hospitals:


cTBS-AH (DFG-funded)
In this study, TMS therapy is offered for the treatment of persistent auditory hallucinations (especially persistent voice hearing). Due to a new form of TMS therapy (so-called theta burst stimulation, TBS), the duration of individual treatments is so short (less than 5 minutes) that the applications are as little stressful as possible for the affected patients.


PREMISS (TMS study in people with schizophrenia and negative symptoms)
In this project, TMS therapy is part of an adjunctive magnetic resonance imaging (MRI) study treating especially negative symptoms. The MRI examinations are used to determine markers that may be decisive for a good treatment response. In the future, MRI will be used to develop an individualized offer for patients within the framework of routine clinical applications.


TBS-D  (TMS Study in People with Depression)
In this study, TMS therapy is offered to treat depressive disorders even before treatment resistance occurs (including no more than 3 treatment attempts to date and a duration of the current episode less than 2 years). Due to a new form of TMS therapy (so-called theta burst stimulation, TBS), the duration of the individual treatments is so short (a few minutes) that the applications are as little stressful as possible for the treated. By stimulating both frontal brain areas (right and left alternately), a particularly effective new application of TMS therapy for depression can be offered.


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  5. Strube W, Aksar A, Bauer I, Barbosa S, Benros M, Blankenstein C, Campana M, Davidovic L, Glaichenhaus N, Falkai P, Görlitz T, Hansbauer M, Heilig D, Khalfallah O, Leboyer M, Martinuzzi E, Mayer S, Moussiopoulou J, Papazova I, Perić N, … & Hasan, A (2022). Effects of add-on Celecoxib treatment on patients with schizophrenia spectrum disorders and inflammatory cytokine profile trial (TargetFlame): study design and methodology of a multicentre randomized, placebo-controlled trial. Journal of neural transmission (Vienna, Austria : 1996), 10.1007/s00702-022-02566-6. Advance online publication. ( https://link.springer.com/article/10.1007/s00702-022-02566-6)

  6. Strube W, Aksar A, Bauer I, Blankenstein C, Campana M, Falkai P, Görlitz T, Hansbauer M, Papazova I, … & Hasan A (2022). Effects of early clozapine treatment on remission rates in acute schizophrenia (EARLY): study design and methodology of a multicentre randomized, placebo-controlled trial. in prep. EudraCT Number: 2018-001514-15.