Effects of Vagus Nerve Stimulation (VNS) as a Treatment of Persistent Depression With Comorbid Personality Disorders (Impulse-VNS (Impuls-V)
|ClinicalTrials.gov Identifier: NCT01119053|
Recruitment Status : Unknown
Verified November 2009 by University Medical Center Goettingen.
Recruitment status was: Recruiting
First Posted : May 7, 2010
Last Update Posted : June 29, 2010
|Condition or disease||Intervention/treatment||Phase|
|Depression Comorbid Personality Disorders||Device: VNS Pulse Model 102||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Study Start Date :||November 2009|
|Estimated Primary Completion Date :||May 2012|
|Estimated Study Completion Date :||November 2012|
Sham Comparator: Arm I
In this branch of study, study participants obtain the VNS therapy after a defined space of time of 12 weeks.
Device: VNS Pulse Model 102
Within this branch, study participants obtain the VNS therapy after a defined space of time of 12 weeks.
Experimental: Arm II
Within this space of time, study participants obtain the VNS therapy at once.
Device: VNS Pulse Model 102
Individual dosage within the realm of 0,25 mA - 3,5 mA. Uninterrupted stimulation of 24 h.
- To analyse whether VNS is effective within the therapy of depression with comorbid personality disorders [ Time Frame: 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).
- Acquisition of Alteration by means of BDI, TMT-A and B, WMS R, VLMT; WHO-QoL, GAF, CGM, SDS [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01119053
|Contact: Claus Wolff-Menzler, MD||+49 551 39 firstname.lastname@example.org|
|Contact: Thomas Wobrock, MD||+49 551 39 email@example.com|
|Dept. of Psychiatry and Psychotherapy (University Medical Centre)||Recruiting|
|Goettingen, Niedersachsen, Germany, 37075|
|Contact: Claus Wolff-Menzler, MD +49 551 39 6610 firstname.lastname@example.org|
|Contact: Thomas Wobrock, MD +49 551 39 6610 email@example.com|
|Principal Investigator: Claus Wolff-Menzler, MD|
|Sub-Investigator: Thomas Wobrock, MD|
|Sub-Investigator: Alkomiet Hasan, MD|
|Study Director:||Peter Falkai, MD||Dept. of Psychiatry and Psychotherapy (University Medical Centre Goettingen, Germany)|
|Principal Investigator:||Claus Wolff-Menzler, MD||Dept. of Psychiatry and Psychotherapy (University Medical Centre Goettingen, Germany)|