Effects of Vagus Nerve Stimulation (VNS) as a Treatment of Persistent Depression With Comorbid Personality Disorders (Impulse-VNS
NCT ID: NCT01119053
Last Updated: 2022-08-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2009-11-30
2014-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Arm I
In this branch of study, study participants obtain the VNS therapy after a defined space of time of 12 weeks.
VNS Pulse Model 102
Within this branch, study participants obtain the VNS therapy after a defined space of time of 12 weeks.
Arm II
Within this space of time, study participants obtain the VNS therapy at once.
VNS Pulse Model 102
Individual dosage within the realm of 0,25 mA - 3,5 mA. Uninterrupted stimulation of 24 h.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
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University Medical Center Goettingen
OTHER
Responsible Party
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Claus Wolff-Menzler
Dr
Principal Investigators
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Peter Falkai, MD
Role: STUDY_DIRECTOR
Dept. of Psychiatry and Psychotherapy (University Medical Centre Goettingen, Germany)
Claus Wolff-Menzler, MD
Role: PRINCIPAL_INVESTIGATOR
Dept. of Psychiatry and Psychotherapy (University Medical Centre Goettingen, Germany)
Locations
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Dept. of Psychiatry and Psychotherapy (University Medical Centre)
Göttingen, Lower Saxony, Germany
Countries
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Related Links
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Dept. of Psychiatry and Psychotherapy (University Medical Centre Goettingen)
Other Identifiers
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01VNS2009
Identifier Type: -
Identifier Source: org_study_id
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