search
Back to results

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

Primary Purpose

Depression, Comorbid Personality Disorders

Status
Withdrawn
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
VNS Pulse Model 102
VNS Pulse Model 102
Sponsored by
University Medical Center Goettingen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring VNS, Depression, Personality-Disorder, Stimulation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dept. of Psychiatry and Psychotherapy (University Medical Centre)

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

Arm I

Arm II

Arm Description

In this branch of study, study participants obtain the VNS therapy after a defined space of time of 12 weeks.

Within this space of time, study participants obtain the VNS therapy at once.

Outcomes

Primary Outcome Measures

To analyse whether VNS is effective within the therapy of depression with comorbid personality disorders
The primary objective of this study is to analyse whether VNS is effective within the therapy of depression with comorbid personality disorders. It shall be verified, as a primary hypothesis, whether VNS with ongoing stimulation is significantly predominant to a non-stimulating control with respect to reducing depressive symptomatology (for differences within HAM-D score and the response rate as the percentage of patients with a reduction in the HAM-D score of at least 50%, week 1 - week 12, see flow-chart).

Secondary Outcome Measures

Acquisition of Alteration by means of BDI, TMT-A and B, WMS R, VLMT; WHO-QoL, GAF, CGM, SDS
Acquisition of the improvement of self-rated depressiveness (BDI), stress axis (cortisol of neurocognition, quality of life (WHO-QoL) and impairment through disease (GAF, CGI, SDS), examination of brain structural and functional parametres as predictors for therapy response (VBM-MRT), Region of Interest Approach and proton magnetic resonance spectroscopy, diagnostic TMS (dTMS) in the beginning of the study.

Full Information

First Posted
May 5, 2010
Last Updated
August 16, 2022
Sponsor
University Medical Center Goettingen
search

1. Study Identification

Unique Protocol Identification Number
NCT01119053
Brief Title
Effects of Vagus Nerve Stimulation (VNS) as a Treatment of Persistent Depression With Comorbid Personality Disorders (Impulse-VNS
Acronym
Impuls-V
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Withdrawn
Why Stopped
No recruitment
Study Start Date
November 2009 (undefined)
Primary Completion Date
May 2012 (Anticipated)
Study Completion Date
November 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Medical Center Goettingen

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Comorbid Personality Disorders
Keywords
VNS, Depression, Personality-Disorder, Stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I
Arm Type
Sham Comparator
Arm Description
In this branch of study, study participants obtain the VNS therapy after a defined space of time of 12 weeks.
Arm Title
Arm II
Arm Type
Experimental
Arm Description
Within this space of time, study participants obtain the VNS therapy at once.
Intervention Type
Device
Intervention Name(s)
VNS Pulse Model 102
Intervention Description
Individual dosage within the realm of 0,25 mA - 3,5 mA. Uninterrupted stimulation of 24 h.
Intervention Type
Device
Intervention Name(s)
VNS Pulse Model 102
Intervention Description
Within this branch, study participants obtain the VNS therapy after a defined space of time of 12 weeks.
Primary Outcome Measure Information:
Title
To analyse whether VNS is effective within the therapy of depression with comorbid personality disorders
Description
The primary objective of this study is to analyse whether VNS is effective within the therapy of depression with comorbid personality disorders. It shall be verified, as a primary hypothesis, whether VNS with ongoing stimulation is significantly predominant to a non-stimulating control with respect to reducing depressive symptomatology (for differences within HAM-D score and the response rate as the percentage of patients with a reduction in the HAM-D score of at least 50%, week 1 - week 12, see flow-chart).
Time Frame
6 Month
Secondary Outcome Measure Information:
Title
Acquisition of Alteration by means of BDI, TMT-A and B, WMS R, VLMT; WHO-QoL, GAF, CGM, SDS
Description
Acquisition of the improvement of self-rated depressiveness (BDI), stress axis (cortisol of neurocognition, quality of life (WHO-QoL) and impairment through disease (GAF, CGI, SDS), examination of brain structural and functional parametres as predictors for therapy response (VBM-MRT), Region of Interest Approach and proton magnetic resonance spectroscopy, diagnostic TMS (dTMS) in the beginning of the study.
Time Frame
6 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Falkai, MD
Organizational Affiliation
Dept. of Psychiatry and Psychotherapy (University Medical Centre Goettingen, Germany)
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Claus Wolff-Menzler, MD
Organizational Affiliation
Dept. of Psychiatry and Psychotherapy (University Medical Centre Goettingen, Germany)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept. of Psychiatry and Psychotherapy (University Medical Centre)
City
Göttingen
State/Province
Niedersachsen
ZIP/Postal Code
37075
Country
Germany

12. IPD Sharing Statement

Links:
URL
http://www.psychiatrie.med.uni-goettingen.de/
Description
Dept. of Psychiatry and Psychotherapy (University Medical Centre Goettingen)

Learn more about this trial

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

We'll reach out to this number within 24 hrs