Effects of Vagus Nerve Stimulation (VNS) as a Treatment of Persistent Depression With Comorbid Personality Disorders (Impulse-VNS

Inclusion criteria

• embedding criteria according to "VNS manual for doctors"

• diagnosis of a recurrent depressive disorder (based on ICD-10 criteria) and a comorbid personality disorder (according to SKID I/II) with an ailment period of more than six months

• age 18-80 years

• verbal IQ (WST) 85 points

• HAM-D sum score > 20 points

• at least four depressive episodes in the anamnesis

• no amelioration of current depressive episodes under two different antidepressants in appropriate dosage for six weeks

• constant medication within the last two weeks (at the discretion of the supervising doctor)

• written consent after informing the patient about the study

• no VNS treatment to date

• no misuse of illegal drugs or alcohol

• Women in childbearing age are not permitted to participate in the study if a doctor has asserted the non-existence of pregnancy before the beginning of the study. Furthermore, the procedure of a pregnancy test is recommended after the completion of the study. During the study, a reliable type of contraception (such as the Pill) should be taken. The doctor provides further information.

Exclusion criteria according to "VNS manual for the doctor"

• present hospitalisation according to the federal states' PsychKG

• clinically relevant unstable bodily concomitant diseases

• former VNS treatment

• reduction of intelligence with verbal IQ < 85 (WST)

• conceivable use of an MRT examination after the implantation of the VNS-system

• for diagnostic examinations with the dTMS and the MRT: electric devices (such as cardiac pacemakers, medicine pumps etc.) or pieces of metal (ferromagnetic, e.g. screws after bone fractures) within or at the body, or large-scale tattoos

• conditions that do not allow to use VNS, such as relevant dysfunctions of the heart's stimulus conduction system or cardiac arrhythmia, stomach ulcer, dysphagia, palsy of parts of the n-vagus nerve

• insufficient knowledge of the German language

• pregnancy or lactation

• current misuse of substances