Depressive DisorderPhase 1/2NCT02562703
tVNS for Depression
A Phase 1/2 study testing Transcutaneous Vagus Nerve Stimulation in people with Depressive Disorder, run by Santa Casa Medical School.
Trial summary
This is a phase II, randomized, sham controlled, clinical trial. This clinical trial has as primary objective to evaluate changes in depressive symptoms of a transcutaneous Vagus Nerve Stimulation (tVNS) treatment protocol for patients with moderate / severe depressive episode. Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Depressive Disorder
- What is being tested?
- Transcutaneous Vagus Nerve Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Nov 2015to Jul 2016
- Phase
- Phase 1/2
- 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 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- patients between 18 and 69 years
- patients with a diagnosis of depression according to the SCID
- score greater than or equal to 18 on the Hamilton Rating Scale 17-item version (equivalent to moderate or severe depressive episode)
- agreement to participate in the study as recommended in the IC.
Who cannot join
- patients with psychiatric indication for hospitalization
- patients with psychiatric comorbidity
- patients with a diagnosis of personality disorder
- presence of severe neurological or medical diseases such as neoplasms in activity, neurodegenerative diseases and chronic diseases uncompensated.
Trial locations and contacts
No sites are listed yet.
Alisson P Trevizol, MD contact
About this study
Official title: Transcutaneous Vagus Nerve Stimulation for Treating Major Depressive Disorder: a Phase II, Randomized, Double-blind Clinical Trial
This is a phase II, randomized, sham controlled, clinical trial. This clinical trial has as primary objective to evaluate changes in depressive symptoms of a transcutaneous Vagus Nerve Stimulation (tVNS) treatment protocol for patients with moderate / severe depressive episode.
- Conditions
- Depressive Disorder
- Being tested
- Transcutaneous Vagus Nerve Stimulation
- Medical subject headings
- Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Vagus Nerve StimulationDevice
tVNS will be applied by the external simulator (Monarch). The stimulation will be conducted at a frequency of 120 Hz with pulse duration of 250 microseconds. The current intensity will be individually established and should be equivalent to a slight feeling of not painful paresthesia .The stimulus generates a pulse and asymmetric biphasic waveform. Electrodes (25cm2) will be placed over the mastoid process bilaterally. The study protocol will follow the rational of our previous trials with TNS.
| Study group | Role | What they receive |
|---|---|---|
| ACTIVE tVNS | Active comparator | tVNS will be applied by the external simulator (Monarch). The stimulation will be conducted at a frequency of 120 Hz with pulse duration of 250 microseconds. The current intensity will be individually established and should be equivalent to a slight feeling of not painful paresthesia .The stimulus generates a pulse and asymmetric biphasic waveform. Electrodes (25cm2) will be placed over the mastoid process bilaterally. The study protocol will follow the rational of our previous trials with TNS. Receives: Device: Transcutaneous Vagus Nerve Stimulation |
| SHAM tVNS | Sham comparator | tVNS will be applied by the external simulator (Monarch). The stimulation will be turned off after 60 seconds following previous trials. Receives: Device: Transcutaneous Vagus Nerve Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
• Hamilton Depressive Rating Scale version 17 items (HDRS-17)
This clinical trial has as primary objective to evaluate the effect of the tVNS on depressive symptoms measured by the Hamilton Depressive Rating Scale version 17 items (HDRS-17) in patients with moderate / severe depressive episode.
Measured: Change from baseline in depressive symptoms at 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2015 (estimated)
- Study startNov 2015
- Primary completionFeb 2016 (estimated)
- Study completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Depressive DisorderStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Santa Casa Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pedro Shiozawa, Santa Casa Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02562703
- Sponsor's protocol ID
- tVNS
- Status last verified
- Sep 2015
- First submitted
- 25 Sep 2015
- Last updated
- 29 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Trevizol AP, Sato IA, Bonadia B, Liquidato BM, Barros MD, Cordeiro Q, Shiozawa P. Trigeminal Nerve Stimulation (TNS) for Major Depressive Disorder in Pregnancy: A Case Study. Brain Stimul. 2015 Sep-Oct;8(5):988-9. doi: 10.1016/j.brs.2015.07.034. Epub 2015 Jul 23. No abstract available.
PubMed 26358492Shiozawa P, Duailibi MS, da Silva ME, Cordeiro Q. Trigeminal nerve stimulation (TNS) protocol for treating major depression: an open-label proof-of-concept trial. Epilepsy Behav. 2014 Oct;39:6-9. doi: 10.1016/j.yebeh.2014.07.021. Epub 2014 Aug 23.
PubMed 25150403Cook IA, Schrader LM, Degiorgio CM, Miller PR, Maremont ER, Leuchter AF. Trigeminal nerve stimulation in major depressive disorder: acute outcomes in an open pilot study. Epilepsy Behav. 2013 Aug;28(2):221-6. doi: 10.1016/j.yebeh.2013.05.008. Epub 2013 Jun 14.
PubMed 23773978
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Vagus Nerve Stimulation for Treating Major Depressive Disorder: a Phase II, Randomized, Double-blind Clinical Trial
- ClinicalTrials.gov ID
- NCT02562703
- Acronym / sponsor ID
- tVNS
- Conditions
- Depressive Disorder
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Santa Casa Medical SchoolUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Feb 2016 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 29 Sep 2015 (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.
This is a phase II, randomized, sham controlled, clinical trial. This clinical trial has as primary objective to evaluate changes in depressive symptoms of a transcutaneous Vagus Nerve Stimulation (tVNS) treatment protocol for patients with moderate / severe depressive episode.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACTIVE tVNS | Active comparator | Device: Transcutaneous Vagus Nerve StimulationtVNS will be applied by the external simulator (Monarch). The stimulation will be conducted at a frequency of 120 Hz with pulse duration of 250 microseconds. The current intensity will be individually established and should be equivalent to a slight feeling of not painful paresthesia .The stimulus generates a pulse and asymmetric biphasic waveform. Electrodes (25cm2) will be placed over the mastoid process bilaterally. The study protocol will follow the rational of our previous trials with TNS. |
| SHAM tVNS | Sham comparator | Device: Transcutaneous Vagus Nerve StimulationtVNS will be applied by the external simulator (Monarch). The stimulation will be turned off after 60 seconds following previous trials. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- patients between 18 and 69 years
- patients with a diagnosis of depression according to the SCID
- score greater than or equal to 18 on the Hamilton Rating Scale 17-item version (equivalent to moderate or severe depressive episode)
- agreement to participate in the study as recommended in the IC.
Key exclusion criteria (4 listed)
- patients with psychiatric indication for hospitalization
- patients with psychiatric comorbidity
- patients with a diagnosis of personality disorder
- presence of severe neurological or medical diseases such as neoplasms in activity, neurodegenerative diseases and chronic diseases uncompensated.
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 |
|---|---|---|
| Transcutaneous Vagus Nerve StimulationtVNS will be applied by the external simulator (Monarch). The stimulation will be conducted at a frequency of 120 Hz with pulse duration of 250 microseconds. The current intensity will be individually established and should be equivalent to a slight feeling of not painful paresthesia .The stimulus generates a pulse and asymmetric biphasic waveform. Electrodes (25cm2) will be placed over the mastoid process bilaterally. The study protocol will follow the rational of our previous trials with TNS. | Device | ACTIVE tVNS, SHAM tVNS |
Primary outcome
• Hamilton Depressive Rating Scale version 17 items (HDRS-17)
Time frame: Change from baseline in depressive symptoms at 2 weeks
This clinical trial has as primary objective to evaluate the effect of the tVNS on depressive symptoms measured by the Hamilton Depressive Rating Scale version 17 items (HDRS-17) in patients with moderate / severe depressive episode.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2015.
- Results publication: PubMed 26358492Trevizol AP, Sato IA, Bonadia B, Liquidato BM, Barros MD, Cordeiro Q, Shiozawa P. Trigeminal Nerve Stimulation (TNS) for Major Depressive Disorder in Pregnancy: A Case Study. Brain Stimul. 2015 Sep-Oct;8(5):988-9. doi: 10.1016/j.brs.2015.07.034. Epub 2015 Jul 23. No abstract available.
- Results publication: PubMed 25150403Shiozawa P, Duailibi MS, da Silva ME, Cordeiro Q. Trigeminal nerve stimulation (TNS) protocol for treating major depression: an open-label proof-of-concept trial. Epilepsy Behav. 2014 Oct;39:6-9. doi: 10.1016/j.yebeh.2014.07.021. Epub 2014 Aug 23.
- Results publication: PubMed 23773978Cook IA, Schrader LM, Degiorgio CM, Miller PR, Maremont ER, Leuchter AF. Trigeminal nerve stimulation in major depressive disorder: acute outcomes in an open pilot study. Epilepsy Behav. 2013 Aug;28(2):221-6. doi: 10.1016/j.yebeh.2013.05.008. Epub 2013 Jun 14.
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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.
Alisson P Trevizol, MD contact
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Transcutaneous Vagus Nerve Stimulation in people with Depressive Disorder, run by Santa Casa Medical School.
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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 29 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alisson P Trevizol, MD (alisson.trevizol@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• Hamilton Depressive Rating Scale version 17 items (HDRS-17) (time frame: Change from baseline in depressive symptoms at 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02562703, which also lists 3 linked publications.
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 29 Sep 2015.