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

University Medical Center Goettingen

Status

Withdrawn

Conditions

Depression

Comorbid Personality Disorders

Treatments

Device: VNS Pulse Model 102

Study type

Interventional

Funder types

Other

Identifiers

NCT01119053

01VNS2009

Details and patient eligibility

About

In this monocentre two-armed double blind randomised placebo-controlled study - in which the control group obtains the VNS therapy within a defined space of time after 12 weeks - the impact of vagus nerve stimulation on depressive symptomatology of patients with therapy-resistant depressive personality disorders shall be analysed. Particularly in comorbid disorders, medicamentous treatment shows exceedingly bad response rates. Against the background of hitherto insufficient treatment strategies for chronic or persistent depression with comorbidities, the proceeding of a study on the effects of VNS on depressive patients with comorbid disorders is absolutely essential.

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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