Effects of Vagus Nerve Stimulation (VNS) as a Treatment of Persistent Depression With Comorbid Personality Disorders (Impulse-VNS (Impuls-V)
Recruitment status was Recruiting
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
- To analyse whether VNS is effective within the therapy of depression with comorbid personality disorders [ Time Frame: 6 Month ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]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.
|Study Start Date:||November 2009|
|Estimated Study Completion Date:||November 2012|
|Estimated Primary Completion Date:||May 2012 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: 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)|