NCT01119053

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University Medical Center Goettingen · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Depression
• Comorbid Personality Disorders

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2009-11-01
• Primary completion: 2012-05-01
• Completion: 2014-11-01
• First posted: 2010-05-07
• Last updated: 2022-08-19

Locations

1 site across 1 country: Germany