Effects of Vagus Nerve Stimulation (VNS) as a Treatment of Persistent Depression With Comorbid Personality Disorders (Impulse-VNS (Impuls-V)
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|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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)|