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

Not Applicable

Withdrawn

• Conditions: Depression; Comorbid Personality Disorders
• Interventions: Device: VNS Pulse Model 102

• Registration Number: NCT01119053
• Lead Sponsor: University Medical Center Goettingen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2010-05-05
• Study First Submitted QC: 2010-05-06
• Study First Posted: 2010-05-07
• Primary Completion: 2012-05
• Study Completion: 2014-11
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-16
• Last Update Posted: 2022-08-19

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm I	VNS Pulse Model 102	In this branch of study, study participants obtain the VNS therapy after a defined space of time of 12 weeks.
Arm II	VNS Pulse Model 102	Within this space of time, study participants obtain the VNS therapy at once.

Primary Outcome Measures

Name	Time	Method
To analyse whether VNS is effective within the therapy of depression with comorbid personality disorders	6 Month	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

Name	Time	Method
Acquisition of Alteration by means of BDI, TMT-A and B, WMS R, VLMT; WHO-QoL, GAF, CGM, SDS	6 month	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.

Trial Locations

Locations (1)

Dept. of Psychiatry and Psychotherapy (University Medical Centre); 🇩🇪 Göttingen, Niedersachsen, Germany