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Hasan, Alkomiet; Roeh, Astrid; Leucht, Stefan; Langguth, Berthold; Hansbauer, Maximilian; Oviedo-Salcedo, Tatiana; Kirchner, Sophie K.; Papazova, Irina; Loehrs, Lisa; Wagner, Elias; Maurus, Isabel; Strube, Wolfgang; Rossner, Moritz J.; Wehr, Michael C.; Bauer, Ingrid; Heres, Stephan; Leucht, Claudia; Kreuzer, Peter M.; Zimmermann, Stephanie; Schneider-Axmann, Thomas; Goerlitz, Thomas; Karch, Susanne; Egert-Schwender, Silvia; Schossow, Beate; Rothe, Philipp; Falkai, Peter (2020): Add-on spironolactone as antagonist of the NRG1-ERBB4 signaling pathway for the treatment of schizophrenia: Study design and methodology of a multicenter randomized, placebo-controlled trial. In: Contemporary Clinical Trials Communications, Vol. 17, 100537
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Abstract

Background: Preclinical studies recently showed that the mineralocorticoid antagonist spironolactone acts also as an antagonist of the NRG1-ERBB4 signaling pathway and improves schizophrenia-like behaviour in Nrg1 transgenic mouse model. As this signaling pathway is critically linked to the pathophysiology of schizophrenia, especially in the context of working-memory dysfunction, spironolactone may be a novel treatment option for patients with schizophrenia targeting cognitive impairments. Aims: To evaluate whether spironolactone added to an ongoing antipsychotic treatment improves cognitive functioning in schizophrenia. Methods: The add-on spironolactone for the treatment of schizophrenia trial (SPIRO-TREAT) is a multicenter randomized, placebo-controlled trial with three arms (spironolactone 100 mg, spironolactone 200 mg and placebo). Schizophrenia patients are treated for three weeks and then followed-up for additional nine weeks. As primary outcome, we investigate changes in working memory before and at the end of the intervention phase. We will randomize 90 patients. Eighty-one patients are intended to reach the primary endpoint measure at the end of the three-week intervention period. Secondary endpoints include other measures of cognition, psychopathology, safety measures and biological measures. Conclusions: SPIRO-TREAT is the first study evaluating the efficacy of the mineralocorticoid receptor antagonist spironolactone to improve cognitive impairments in schizophrenia patients targeting the NRG1-ERBB4 signaling pathway. With SPIRO-TREAT, we intend to investigate a novel treatment option for cognitive impairments in schizophrenia that goes beyond the established concepts of interfering with dopaminergic neurotransmission as key pathway in schizophrenia treatment.