DepressionImpuls-VNCT01119053
Effects of Vagus Nerve Stimulation (VNS) as a Treatment of Persistent Depression With Comorbid Personality Disorders (Impulse-VNS
A study testing VNS Pulse Model 102 in people with Depression and Comorbid Personality Disorders, run by University Medical Center Goettingen at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Depression, Comorbid Personality Disorders
- What is being tested?
- VNS Pulse Model 102
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2009to Nov 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- embedding criteria according to "VNS manual for doctors"
- 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
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- 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.
Who cannot join
- present hospitalisation according to the federal states' PsychKG
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Dept. of Psychiatry and Psychotherapy (University Medical Centre)
Göttingen, Lower Saxony, 37075
About this study
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
- Depression, Comorbid Personality Disorders
- Being tested
- VNS Pulse Model 102
- Keywords
- VNS, Depression, Personality-Disorder, Stimulation
- Medical subject headings
- Depression, Personality Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VNS Pulse Model 102Device
Individual dosage within the realm of 0,25 mA - 3,5 mA. Uninterrupted stimulation of 24 h.
VNS Pulse Model 102Device
Within this branch, study participants obtain the VNS therapy after a defined space of time of 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Sham comparator | In this branch of study, study participants obtain the VNS therapy after a defined space of time of 12 weeks. Receives: Device: VNS Pulse Model 102 |
| Arm II | Experimental | Within this space of time, study participants obtain the VNS therapy at once. Receives: Device: VNS Pulse Model 102 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To analyse whether VNS is effective within the therapy of depression with comorbid personality disorders
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).
Measured: 6 Month
Secondary outcomes (1)
Acquisition of Alteration by means of BDI, TMT-A and B, WMS R, VLMT; WHO-QoL, GAF, CGM, SDS
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.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2010 (estimated)
- Study startNov 2009
- Primary completionMay 2012 (estimated)
- Study completionNov 2014 (estimated)
Why it stopped: No recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Goettingen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claus Wolff-Menzler, University Medical Center Goettingen
- Investigators
- Peter Falkai, MD, Study director, Dept. of Psychiatry and Psychotherapy (University Medical Centre Goettingen, Germany)Claus Wolff-Menzler, MD, Principal investigator, Dept. of Psychiatry and Psychotherapy (University Medical Centre Goettingen, Germany)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01119053
- Sponsor's protocol ID
- 01VNS2009
- Acronym
- Impuls-V
- Status last verified
- Aug 2022
- First submitted
- 5 May 2010
- Last updated
- 19 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Vagus Nerve Stimulation (VNS) as a Treatment of Persistent Depression With Comorbid Personality Disorders (Impulse-VNS
- ClinicalTrials.gov ID
- NCT01119053
- Acronym / sponsor ID
- Impuls-V / 01VNS2009
- Conditions
- Depression, Comorbid Personality Disorders
- Keywords
- VNS, Depression, Personality-Disorder, Stimulation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No recruitment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Medical Center GoettingenUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- May 2012 (estimated)
- Study completion
- Nov 2014 (estimated)
- First posted
- 7 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I | Sham comparator | Device: VNS Pulse Model 102In this branch of study, study participants obtain the VNS therapy after a defined space of time of 12 weeks. |
| Arm II | Experimental | Device: VNS Pulse Model 102Within this space of time, study participants obtain the VNS therapy at once. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- embedding criteria according to "VNS manual for doctors"
- 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
Key exclusion criteria (10 listed)
- present hospitalisation according to the federal states' PsychKG
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VNS Pulse Model 102Individual dosage within the realm of 0,25 mA - 3,5 mA. Uninterrupted stimulation of 24 h. | Device | Arm II |
| VNS Pulse Model 102Within this branch, study participants obtain the VNS therapy after a defined space of time of 12 weeks. | Device | Arm I |
Primary outcome
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).
1 secondary outcome
Acquisition of Alteration by means of BDI, TMT-A and B, WMS R, VLMT; WHO-QoL, GAF, CGM, SDS
Time frame: 6 month
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Falkai, MD study director
Dept. of Psychiatry and Psychotherapy (University Medical Centre Goettingen, Germany)
Claus Wolff-Menzler, MD principal investigator
Dept. of Psychiatry and Psychotherapy (University Medical Centre Goettingen, Germany)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VNS Pulse Model 102 in people with Depression and Comorbid Personality Disorders, run by University Medical Center Goettingen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 19 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To analyse whether VNS is effective within the therapy of depression with comorbid personality disorders (time frame: 6 Month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2022; AzTrials last refreshed its copy on 8 Nov 2026.