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

NCT01119053 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2022-08-19

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • University Medical Center Goettingen

    lead OTHER

Principal Investigators

  • Peter Falkai, MD · Dept. of Psychiatry and Psychotherapy (University Medical Centre Goettingen, Germany)

  • Claus Wolff-Menzler, MD · Dept. of Psychiatry and Psychotherapy (University Medical Centre Goettingen, Germany)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2012-05-31
Completion
2014-11-30

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01119053 on ClinicalTrials.gov