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

Brief Summary

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.

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
  • Study Primary Completion Date: May 2012

Interventions Used in this Clinical Trial

  • Device: VNS Pulse Model 102
    • Individual dosage within the realm of 0,25 mA – 3,5 mA. Uninterrupted stimulation of 24 h.
  • Device: VNS Pulse Model 102
    • Within this branch, study participants obtain the VNS therapy after a defined space of time of 12 weeks.

Arms, Groups and Cohorts in this Clinical Trial

  • Sham Comparator: Arm I
    • In this branch of study, study participants obtain the VNS therapy after a defined space of time of 12 weeks.
  • Experimental: Arm II
    • Within this space of time, study participants obtain the VNS therapy at once.

Outcome Measures for this Clinical Trial

Primary Measures

  • To analyse whether VNS is effective within the therapy of depression with comorbid personality disorders
    • Time Frame: 6 Month
      Safety Issue?: No

Secondary Measures

  • Acquisition of Alteration by means of BDI, TMT-A and B, WMS R, VLMT; WHO-QoL, GAF, CGM, SDS
    • Time Frame: 6 month
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

  • Lead Sponsor
    • University Medical Center Goettingen
  • Provider of Information About this Clinical Study
    • University Medical Center Goettingen, Dept. of Psychiatry and Psychotherapy
  • Overall Official(s)
    • Peter Falkai, MD, Study Director, Dept. of Psychiatry and Psychotherapy (University Medical Centre Goettingen, Germany)
    • Claus Wolff-Menzler, MD, Principal Investigator, Dept. of Psychiatry and Psychotherapy (University Medical Centre Goettingen, Germany)
  • Overall Contact(s)
    • Claus Wolff-Menzler, MD, +49 551 39 6610, cwolff@gwdg.de


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