Randomized, controlled, double-blind, two-armed clinical investigation to show the efficacy and safety of transcutaneous vagus nerve stimulation (t-VNS), applied at the left auricle, in schizophrenia. Study hypothesis: t-VNS may improve negative symptoms, depressive symptoms, cognitive impairment,and aggressive behavior of treated schizophrenia patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
20
Active stimulation of the left auricle by t-VNS
Sham stimulation of the left auricle with the t-VNS device
Department of Psychiatry and Psychotherapy, Ludwig-Maximilians-Universitaet Muenchen
Munich, Bavaria, Germany
Departement of Psychiatry and Psychotherapy, University Hospital of Goettingen
Göttingen, Lower Saxony, Germany
Safety and efficacy of t-VNS in schizophrenia
Time frame: 24 weeks
Recording of clinical performance of t-VNS in schizophrenia
self rating: * BDI * Fagerström rating by investigator * UKU * SANS * CDSS * MARDS * HAMD-21 * CGI * PSP * SWN\_K * St. Hans * VLMT * TMT-B * TMT-A * RWT * Corsi Block Tapping * Zahlennachsprechen * MWT-B * EKT * HR * dTMS
Time frame: 24 weeks
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