Refractory DepressionPhase 1/2NCT04153812
Clinical Study on the Safety and Effectiveness of Vagus Nerve Stimulation in the Treatment of Refractory Depression
A Phase 1/2 study testing vagus nerve stimulation in people with Refractory Depression, run by Xijing Hospital at 1 site in China.
Trial summary
Based on the mechanism hypothesis and clinical efficacy of VNS in treating refractory depression, this study will evaluate the safety and efficacy of VNS in treating refractory depression through a small sample of clinical trials Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Refractory Depression
- What is being tested?
- vagus nerve stimulation
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2019to 30 May 2022
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with treatment-resistant depression (patients with Hamilton depression scale (HAMD) score reduction rate still less than 50% after adequate treatment with two or more antidepressants)
- age 18-65; Male or female
- the patient has a depressive course of 2 years or more or has 2 or more major depressive episodes
- HAMD-17 score> 17 was at baseline
Who cannot join
- pregnant or lactating women, women of childbearing age who plan or have no safe contraceptive measures
- a patient who is or has been diagnosed with a mental disorder other than depression; Depressive episode with psychotic symptoms
- patients currently at serious risk of suicide
- prior 12 months of alcohol or substance dependence, or prior 6 months of substance abuse other than nicotine
- patients with cardiovascular diseases (myocardial infarction or cardiac arrest) and organic brain diseases (such as cerebral hemorrhage, massive cerebral infarction, encephalitis and epilepsy)
- accept other clinical trials
- patients requiring systemic mri after implantation
Trial locations and contacts
1 site in 1 country.
Chen Yihuan contact
About this study
Based on the mechanism hypothesis and clinical efficacy of VNS in treating refractory depression, this study will evaluate the safety and efficacy of VNS in treating refractory depression through a small sample of clinical trials
Read the detailed description
This clinical trial is a prospective, self - controlled clinical validation study. Subjects who met the inclusion criteria and did not meet the exclusion criteria were screened to enter the test. After admission, subjects received vagus nerve stimulation and conventional treatment. Enrolled 10 subjects. Parameter setting and observation were performed 2 weeks after implantation of the vagus nerve stimulation lead and pulse generator, and follow-up evaluation was performed at 3, 6 and 12 months.
- Conditions
- Refractory Depression
- Being tested
- vagus nerve stimulation
- Medical subject headings
- Depressive Disorder, Treatment-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vagus nerve stimulationDevice
Vagus nerve stimulation (VNS) is a new technique for stimulating the left cervical vagus nerve through implanted lead and a programmable pulse generator.
What is being measured
The primary outcome is the main question the study is designed to answer.
HAMD-17
HAMD-17 score reduction rate at 6 months of follow-up compared to baseline
Measured: 6 months
Secondary outcomes (5)
HAMD-17
HAMD-17 score reduction rate at 3，12 months of follow-up compared to baseline
Measured: 12months
MADRS
Changes in MADRS scores at 3, 6, and 12 months of follow-up compared to baseline
Measured: 12months
IDS-SR
Changes in IDS-SR scores at 3, 6, and 12 months of follow-up compared to baseline
Measured: 12months
CGI
Changes in CGI scores at 3, 6, and 12 months of follow-up compared to baseline
Measured: 12months
PSQI
Changes in PSQI scores at 3, 6, and 12 months of follow-up compared to baseline
Measured: 12months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2019
- Study start1 Nov 2019 (estimated)
- Primary completion1 Oct 2021 (estimated)
- Study completion30 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory DepressionStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04153812
- Sponsor's protocol ID
- VNS20190620
- Status last verified
- Oct 2019
- First submitted
- 3 Nov 2019
- Last updated
- 6 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Safety and Effectiveness of Vagus Nerve Stimulation in the Treatment of Refractory Depression
- ClinicalTrials.gov ID
- NCT04153812
- Acronym / sponsor ID
- VNS20190620
- Conditions
- Refractory Depression
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 1 Nov 2019 (estimated)
- Primary completion
- 1 Oct 2021 (estimated)
- Study completion
- 30 May 2022 (estimated)
- First posted
- 6 Nov 2019 (actual)
- 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.
Based on the mechanism hypothesis and clinical efficacy of VNS in treating refractory depression, this study will evaluate the safety and efficacy of VNS in treating refractory depression through a small sample of clinical trials
Detailed description
This clinical trial is a prospective, self - controlled clinical validation study. Subjects who met the inclusion criteria and did not meet the exclusion criteria were screened to enter the test. After admission, subjects received vagus nerve stimulation and conventional treatment. Enrolled 10 subjects. Parameter setting and observation were performed 2 weeks after implantation of the vagus nerve stimulation lead and pulse generator, and follow-up evaluation was performed at 3, 6 and 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients with treatment-resistant depression (patients with Hamilton depression scale (HAMD) score reduction rate still less than 50% after adequate treatment with two or more antidepressants)
- age 18-65; Male or female
- the patient has a depressive course of 2 years or more or has 2 or more major depressive episodes
- HAMD-17 score> 17 was at baseline
Key exclusion criteria (7 listed)
- pregnant or lactating women, women of childbearing age who plan or have no safe contraceptive measures
- a patient who is or has been diagnosed with a mental disorder other than depression; Depressive episode with psychotic symptoms
- patients currently at serious risk of suicide
- prior 12 months of alcohol or substance dependence, or prior 6 months of substance abuse other than nicotine
- patients with cardiovascular diseases (myocardial infarction or cardiac arrest) and organic brain diseases (such as cerebral hemorrhage, massive cerebral infarction, encephalitis and epilepsy)
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 |
|---|---|---|
| vagus nerve stimulationVagus nerve stimulation (VNS) is a new technique for stimulating the left cervical vagus nerve through implanted lead and a programmable pulse generator. | Device | – |
Primary outcome
HAMD-17
Time frame: 6 months
HAMD-17 score reduction rate at 6 months of follow-up compared to baseline
5 secondary outcomes
HAMD-17
Time frame: 12months
MADRS
Time frame: 12months
IDS-SR
Time frame: 12months
CGI
Time frame: 12months
PSQI
Time frame: 12months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2019.
- Individual participant dataSharing planned: Undecided
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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.
Chen Yihuan contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing vagus nerve stimulation in people with Refractory Depression, run by Xijing Hospital at 1 site in China.
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 7 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 6 Nov 2019. 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 China. 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. 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 Wang Huaning (13609161341, xskzhu@fmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HAMD-17 (time frame: 6 months). 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 6 Nov 2019.