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

Depression Clinical Trial

— Impuls-V  

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01119053
• Other study ID #: 01VNS2009
• Status: Withdrawn
• Phase: N/A
• Start date: November 2009
• Est. completion date: November 2014

Study information

• Verified date: August 2022
• Source: University Medical Center Goettingen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2014
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Comorbid Personality Disorders
• Depression
• Depressive Disorder
• Personality Disorders

Intervention

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

Locations

Country	Name	City	State
Germany	Dept. of Psychiatry and Psychotherapy (University Medical Centre)	Göttingen	Niedersachsen

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center Goettingen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	6 Month
Secondary	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.	6 month

External Links

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