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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by University Medical Center Goettingen.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Medical Center Goettingen
ClinicalTrials.gov Identifier:
NCT01119053
First received: May 5, 2010
Last updated: June 28, 2010
Last verified: November 2009
  Purpose

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.


Condition Intervention
Depression
Comorbid Personality Disorders
Device: VNS Pulse Model 102

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

Resource links provided by NLM:


Further study details as provided by University Medical Center Goettingen:

Primary Outcome Measures:
  • To analyse whether VNS is effective within the therapy of depression with comorbid personality disorders [ Time Frame: 6 Month ] [ Designated as safety issue: No ]

    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 [ Time Frame: 6 month ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 40
Study Start Date: November 2009
Estimated Study Completion Date: November 2012
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: Arm I
In this branch of study, study participants obtain the VNS therapy after a defined space of time of 12 weeks.
Device: VNS Pulse Model 102
Within this branch, 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.
Device: VNS Pulse Model 102
Individual dosage within the realm of 0,25 mA - 3,5 mA. Uninterrupted stimulation of 24 h.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01119053

Contacts
Contact: Claus Wolff-Menzler, MD +49 551 39 6610 cwolff@gwdg.de
Contact: Thomas Wobrock, MD +49 551 39 6610 twobroc@gwdg.de

Locations
Germany
Dept. of Psychiatry and Psychotherapy (University Medical Centre) Recruiting
Goettingen, Niedersachsen, Germany, 37075
Contact: Claus Wolff-Menzler, MD    +49 551 39 6610    cwolff@gwdg.de   
Contact: Thomas Wobrock, MD    +49 551 39 6610    twobroc@gwdg.de   
Principal Investigator: Claus Wolff-Menzler, MD         
Sub-Investigator: Thomas Wobrock, MD         
Sub-Investigator: Alkomiet Hasan, MD         
Sponsors and Collaborators
University Medical Center Goettingen
Investigators
Study Director: Peter Falkai, MD Dept. of Psychiatry and Psychotherapy (University Medical Centre Goettingen, Germany)
Principal Investigator: Claus Wolff-Menzler, MD Dept. of Psychiatry and Psychotherapy (University Medical Centre Goettingen, Germany)
  More Information

Additional Information:
No publications provided

Responsible Party: University Medical Center Goettingen, Dept. of Psychiatry and Psychotherapy
ClinicalTrials.gov Identifier: NCT01119053     History of Changes
Other Study ID Numbers: 01VNS2009
Study First Received: May 5, 2010
Last Updated: June 28, 2010
Health Authority: Germany: Ethics Commission

Keywords provided by University Medical Center Goettingen:
VNS
Depression
Personality-Disorder
Stimulation

Additional relevant MeSH terms:
Personality Disorders
Depression
Depressive Disorder
Mental Disorders
Behavioral Symptoms
Mood Disorders

ClinicalTrials.gov processed this record on September 11, 2014