SchizophreniaPhase 202VNS2009NCT01176721
Transcutaneous Non-invasive Vagus Nerve Stimulation (t-VNS) in the Treatment of Schizophrenia
A Phase 2 study testing t-VNS verum in people with Schizophrenia, run by cerbomed GmbH at 2 sites in Germany.
Trial summary
Randomized, controlled, double-blind, two-armed clinical investigation to show the efficacy and safety of transcutaneous vagus nerve stimulation (t-VNS), applied at the left auricle, in schizophrenia. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- t-VNS verum
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 2 sitesGermany
- Study dates
- Mar 2010to Feb 2012
- Phase
- Phase 2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of a schizophrenic disorder (F20 according to ICD-10),duration of disease ≥ 12 months
- Appliance of the t-VNS® medical device according to the manual
Who cannot join
- Improvent of the PANSS score within the period of 2 - 4 weeks from screening to the baseline
- Pregnancy
- Bronchial asthhma in medical history
- clinically relevant internistic, neurological or psychiatric diseases
- abuse of drugs or alcohol until 4 weeks to enrollment
- Traumatic brain injury in medical history as well as invasive and non-invasive methods of treatment (e.g. tumor surgery (Gammma knife surgery))
Show all 9Show fewer
- indication of structural impairment of the basal ganglia or the brain stem
- malformations of the pinna
- further circumstances that at the discretion of the investigator will not allow to include the subject into the clinical study
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Departement of Psychiatry and Psychotherapy, University Hospital of Goettingen
Göttingen, Lower Saxony, 37075
Department of Psychiatry and Psychotherapy, Ludwig-Maximilians-Universitaet Muenchen
Munich, Bavaria, 80336
About this study
Official title: Transcutaneous Non-invasive Vagus Nerve Stimulation (t-VNS) in the Treatment of Schizophrenia: a Randomized, Controlled, Double Blind, Two-armed Clinical Trial
Randomized, controlled, double-blind, two-armed clinical investigation to show the efficacy and safety of transcutaneous vagus nerve stimulation (t-VNS), applied at the left auricle, in schizophrenia.
Study hypothesis: t-VNS may improve negative symptoms, depressive symptoms, cognitive impairment,and aggressive behavior of treated schizophrenia patients.
- Conditions
- Schizophrenia
- Being tested
- t-VNS verum, t-VNS placebo
- Keywords
- schizophrenic disorders, psychosis, psychotic, dementia, delusional, delusions, hallucinations, residual-type schizophrenia, illusions, split mind, mental health disorder, schizoid, paranoid-type schizophrenia, disorganized-type schizophrenia, undifferentiated-type schizophrenia, catatonic-type schizophrenia, mental illness, tardive dyskinesia, neuroleptic malignant syndrome, NMS
- Medical subject headings
- Schizophrenia, Psychotic Disorders, Mental Disorders, Dementia, Delusions, Hallucinations, Illusions, Schizophrenia, Paranoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
t-VNS verumDevice
Active stimulation of the left auricle by t-VNS
t-VNS placeboDevice
Sham stimulation of the left auricle with the t-VNS device
| Study group | Role | What they receive |
|---|---|---|
| t-VNS verum | Active comparator | Active stimulation of the left auricle by t-VNS Receives: Device: t-VNS verum |
| Sham | Placebo comparator | Sham-simulation of the left auricle by the t-VNS device. Receives: Device: t-VNS placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and efficacy of t-VNS in schizophrenia
Measured: 24 weeks
Secondary outcomes (1)
Recording of clinical performance of t-VNS in schizophrenia
self rating:
- BDI
- Fagerström rating by investigator
- UKU
- SANS
- CDSS
- MARDS
- HAMD-21
- CGI
- PSP
- SWN_K
- St. Hans
- VLMT
- TMT-B
- TMT-A
- RWT
- Corsi Block Tapping
- Zahlennachsprechen
- MWT-B
- EKT
- HR
- dTMS
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2010 (estimated)
- Study startMar 2010
- Primary completionJul 2011
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- cerbomed GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01176721
- Sponsor's protocol ID
- 02VNS2009
- Acronym
- 02VNS2009
- Status last verified
- Sep 2012
- First submitted
- 5 Aug 2010
- Last updated
- 12 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Non-invasive Vagus Nerve Stimulation (t-VNS) in the Treatment of Schizophrenia: a Randomized, Controlled, Double Blind, Two-armed Clinical Trial
- ClinicalTrials.gov ID
- NCT01176721
- Acronym / sponsor ID
- 02VNS2009 / 02VNS2009
- Conditions
- Schizophrenia
- Keywords
- schizophrenic disorders, psychosis, psychotic, dementia, delusional, delusions, hallucinations, residual-type schizophrenia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- cerbomed GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH
- Study start
- Mar 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 6 Aug 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.
Randomized, controlled, double-blind, two-armed clinical investigation to show the efficacy and safety of transcutaneous vagus nerve stimulation (t-VNS), applied at the left auricle, in schizophrenia.
Study hypothesis: t-VNS may improve negative symptoms, depressive symptoms, cognitive impairment,and aggressive behavior of treated schizophrenia patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| t-VNS verum | Active comparator | Device: t-VNS verumActive stimulation of the left auricle by t-VNS |
| Sham | Placebo comparator | Device: t-VNS placeboSham-simulation of the left auricle by the t-VNS device. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of a schizophrenic disorder (F20 according to ICD-10),duration of disease ≥ 12 months
- Appliance of the t-VNS® medical device according to the manual
Key exclusion criteria (9 listed)
- Improvent of the PANSS score within the period of 2 - 4 weeks from screening to the baseline
- Pregnancy
- Bronchial asthhma in medical history
- clinically relevant internistic, neurological or psychiatric diseases
- abuse of drugs or alcohol until 4 weeks to enrollment
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 |
|---|---|---|
| t-VNS verumActive stimulation of the left auricle by t-VNS | Device | t-VNS verum |
| t-VNS placeboSham stimulation of the left auricle with the t-VNS device | Device | Sham |
Primary outcome
Safety and efficacy of t-VNS in schizophrenia
Time frame: 24 weeks
1 secondary outcome
Recording of clinical performance of t-VNS in schizophrenia
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing t-VNS verum in people with Schizophrenia, run by cerbomed GmbH at 2 sites 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 2 inclusion and 9 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: finished, as of the sponsor's last update on 12 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Safety and efficacy of t-VNS in schizophrenia (time frame: 24 weeks). 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 12 Sep 2012.