Treatment Resistant DepressionRESTORE-LIFENCT03320304
A Study to Assess Effectiveness and Efficiency of VNS Therapy in Patients With Difficult to Treat Depression.
An observational study of Treatment Resistant Depression, run by LivaNova at 18 sites in 4 countries.
Trial summary
The primary objective of this study is to assess short, mid and long-term clinical outcomes in patients with difficult to treat depression (such as patients with treatment resistant depression) treated with Vagus Nerve Stimulation (VNS) Therapy as adjunctive therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Treatment Resistant Depression
- What is being tested?
- Vagal Nerve Simulation (VNS) Therapy
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- 18 sitesin 4 countries
- Study dates
- 14 Dec 2017to 1 Dec 2031
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The population under study comprises a real-world patient population with difficult to treat depression: patients diagnosed with unipolar or bipolar disorder with chronic or recurrent depression who fail to achieve an adequate response to standard psychiatric management. The diagnosis of depression and comorbid disorders will be determined based on the Mini International Neuropsychiatric Interview (MINI).
Who may be able to join
- Be at least 18 years of age.
- Have a documented primary diagnosis of chronic (>2 years) or recurrent (2 or more prior episodes) major depressive episode that has not adequately responded to an adequate number of antidepressant treatments, as per local medical standards. This diagnosis must be confirmed using the MINI.
- Provide written Ethics Committee (EC) or Institutional Review Board (IRB) approved informed consent and Health Insurance Portability and Accountability Act (HIPAA, US only) authorization (as applicable according to local requirements).
- Currently is receiving at least one antidepressant treatment (i.e., antidepressant drug, maintenance electroconvulsive therapy, or formal psychotherapy including supportive psychotherapy) or mood stabilizing treatment for bipolar patients (such as lithium, anticonvulsants, or atypical antipsychotics).
- Able and willing to comply with the frequency of (outpatient) clinic visits and to reliably complete all the evaluations as specified in the study protocol.Hence based on the nature of their disease, the following patients should not be included: patients with mental retardation, current severe or significant substance/alcohol abuse, diagnosis of one or more schizophrenia-spectrum or other psychotic disorders, diagnosis of borderline or severe personality disorder as determined by clinical judgment which, in the investigator's opinion, would significantly interfere with subject's participation in the study)
Who cannot join
- There are no exclusion criteria; the investigator should refer to the (local applicable) VNS Therapy Physician's Manual.
Trial locations and contacts
18 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
Gaia Giannicola contact
18 sites in 4 countries
Germany12 sites, 6 recruiting
- Withdrawn
Sozialstiftung Bamberg - Klinikum am Bruderwald
Bamberg
- Recruiting
Universitätsklinikum Bonn
Bonn
Margaretha Klein, MD
- Recruiting
Universitätsklinikum Köln
Cologne
Fritz-Georg Lehnhardt
- Recruiting
LVR-Hospital Essen
Essen, 45147
Norbert Scherbaum, Prof.
- Recruiting
Universitätsklinikum Frankfurt
Frankfurt
Christine Reif-Leonhard
- Completed
Universitätsklinikum Freiburg
Freiburg im Breisgau
- Withdrawn
Universitätsmedizin Göttingen
Göttingen
- Withdrawn
Medizinische Hochschule Hannover
Hanover
- Completed
Universitätsklinikum Jena
Jena
- Recruiting
Universitätsklinik Leipzig
Leipzig, 04103
Maria Strauss, MD
- Recruiting
University Hospital Münster
Münster
Bernhard Baune, Prof.
- Active, not recruiting
Klinikum Wilhelmshaven
Wilhelmshaven
United Kingdom4 sites, 3 recruiting
- Recruiting
Glenfield hospital
Leicester, LE3 9EJ
Ganesh Kunjithapatham, Dr.
- Recruiting
King's College London
London
Roland Zahn, Prof.
- Recruiting
Academic Psychiatry Wolfson Research Centre
Newcastle upon Tyne
Tiago da Silva Costa, Dr.
- Active, not recruiting
Mendip HTT / St Andrew's Ward
Wells, BA5 1TH
Austria1 site, 1 recruiting
- Recruiting
AKH Allgemeines Krankenhaus der Stadt Wien
Vienna, 1090
Christoph Kraus, Dr.
Belgium1 site, 1 recruiting
- Recruiting
KU Leuven
Leuven
Koen Demyttenaere, Prof.
About this study
Official title: A Global PRospective, Multi-cEnter, ObServational Post-markeT Study tO Assess shoRt, Mid and Long-term Effectiveness and Efficiency of VNS Therapy® as Adjunctive Therapy in reaL-world patIents With diFficult to Treat dEpression.
The primary objective of this study is to assess short, mid and long-term clinical outcomes in patients with difficult to treat depression (such as patients with treatment resistant depression) treated with Vagus Nerve Stimulation (VNS) Therapy as adjunctive therapy.
Read the detailed description
The population under study comprises a real-world patient population with difficult to treat depression: patients diagnosed with unipolar or bipolar disorder with chronic or recurrent depression who fail to achieve an adequate response to standard psychiatric management.
The diagnosis of depression and comorbid disorders will be determined based on the Mini International Neuropsychiatric Interview (MINI).
A minimum of five hundred (500) patients will be implanted with a VNS Therapy System and up to eighty (80) sites may participate in this study.
Enrollment will take 11 years, based on competitive enrollment. For each subject a baseline visit will occur between 1 and 6 weeks before implant.
Once implanted with the device, subjects will be followed-up for a minimum of 36 months and a maximum of 60 months. The study may stop when the last subject has reached the 36 months follow-up.
- Conditions
- Treatment Resistant Depression
- Being tested
- Vagal Nerve Simulation (VNS) Therapy
- Keywords
- Difficult to Treat Depression, TRD, VNS Therapy, Vagus Nerve Stimulation, VNS
- 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.
Vagal Nerve Simulation (VNS) TherapyDevice
A VNS Therapy System used for vagus nerve stimulation and consisting of an implantable VNS Therapy generator, lead, and external programming system.
| Study group | Role | What they receive |
|---|---|---|
| Vagal Nerve Simulation (VNS) Therapy | The aim of this study is to include patients with difficult to treat depression from a global "real world" (standard of care) population who are referred for treatment with VNS Therapy. Receives: Device: Vagal Nerve Simulation (VNS) Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint of this study is response defined as reduction in Montgomery Åsberg Depression Rating Scale (MADRS) total score of at least 50% from baseline to 12 months post implant.
MADRS is a 10-item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. Each item yields a score of 0 to 6. The overall score ranges from 0 to 60. Higher MADRS score indicates more severe depression.
A 'Responder' is a subject that achieved ≥ 50% reduction from baseline in MADRS total score at the M12 assessment. A 'Non-Responder' is any patient who did not achieve ≥ 50% reduction from baseline in MADRS score at the M12 assessment.
No formal hypothesis testing is presented; all the proposed statistical tests are descriptive in nature.
The Primary endpoint analysis as defined above will be done only on patients that are enrolled while in a major depressive episode (MDE); the cut off point for current MDE at time of implant will be a MADRS score of 20.
For the patients with a MADRS score below 20 at time of enrollment, only the continuous change in MADRS can be described (as the MADRS can only worsen or stay the same).
Measured: 12 months
Secondary outcomes (16)
Duration of response
computed as the difference between the first recorded date post baseline that response is achieved (MADRS reduction from baseline ≥ 50%) and the first date at which MADRS again increased to a level of <40% from baseline.
Measured: through study completion, an average of 4 years
Change in MADRS
Change in MADRS over time
Measured: through study completion, an average of 4 years
Cumulative response
Cumulative percentage of first-time MADRS responders (MADRS reduction from baseline ≥ 50%) at any post-baseline visit.
Measured: through study completion, an average of 4 years
Cumulative remission
Cumulative percentage of subjects in remission (MADRS ≤9) at any post-baseline visit.
Measured: through study completion, an average of 4 years
Changes in depression score As measured by the Quick Inventory of Depressive Symptomatology Self-Report (QIDS-SR).
The Quick Inventory of Depressive Symptomatology (QIDS-SR) is a 16-item, subject-completed questionnaire of the symptoms of mood and depression. The total score ranges from 0 to 27. A higher QIDS-SR score indicates a more severe depression.
Measured: through study completion, an average of 4 years
Changes in mania score as measured by the Altman Self-Rating Mania Scale (ASRM)*.
*Optional assessments: to be done at selected sites only and based on investigator's clinical judgment to decide which subjects complete them.
The Altman Self-rating Mania Scale (ASRM) is a 5-item self-reported diagnostic scale which can be used to assess the presence and severity manic and hypomanic symptoms, most commonly in patients diagnosed with bipolar disorder. The total score ranges from 0 to 20. A score of 6 or higher indicates a high probability of a manic or hypomanic condition.
Measured: through study completion, an average of 4 years
Changes in Quality of Life as measured by the EuroQol five dimensions questionnaire (EQ-5D-5L)
The EuroQol five dimensions questionnaire (EQ-5D-5L) is a standardized 5-item subject completed questionnaire measuring generic health status and quality of life.
Measured: through study completion, an average of 4 years
Changes in patient function as measured by the Work Productivity and Activity Impairment Scale (WPAI)
The Work Productivity and Activity Impairment Questionnaire (WPAI) is a subject self-reported 6-item questionnaire that measures impairments in work and activities. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.
Measured: through study completion, an average of 4 years
Changes in Quality of Life and patient function as measured by the Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF)
The Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) is a standardized 16-item, self-report scale to assess the degree of enjoyment and satisfaction experienced by the subject during the past week.
Measured: through study completion, an average of 4 years
Changes in suicidality as measured by item #10 of MADRS.
Item 10 on the Montgomery-Åsberg Depression Rating Scale (MADRS) scale assesses suicidal thoughts as representing the feeling that life is not worth living, that a natural death would be welcome, suicidal thoughts and preparations for suicide and is rated from 0 to 6. A score of ≥ 4 ('probably better off dead') is of particular interest.
Measured: through study completion, an average of 4 years
Changes in suicidality as measured by item #12 of QIDS-SR.
For Item 12 of the Quick Inventory of Depressive Symptomatology (QIDS-SR), the subject assesses any thoughts of death or suicide over the previous 7 days on a 4- point scale; a score of ≥ 2 ('I think of suicide or death several times a week for several minutes') being of interest.
Measured: through study completion, an average of 4 years
Changes in adjunctive antidepressant pharmacological treatment
All adjunctive concomitant antidepressant and psychotropic medications will be collected
Measured: through study completion, an average of 4 years
Changes in adjunctive antidepressant non-pharmacological treatment
The following adjunctive non-pharmacological treatments will be collected: maintenance electroconvulsive therapy (ECT), Transcranial Magnetic Stimulation (TMS) and psychotherapy
Measured: through study completion, an average of 4 years
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
The following adverse events will be collected: serious adverse events, deaths, VNS Therapy related adverse events and device deficiencies.
Measured: through study completion, an average of 4 years
Changes in cognition
As measured by THINC-it® Tool*.
*Optional assessments: to be done at selected sites only and based on investigator's clinical judgment to decide which subjects complete them.
Measured: through study completion, an average of 4 years
Changes in anxiety as measured by the Generalized Anxiety Disorder Assessment (GAD 7)*.
*Optional assessments: to be done at selected sites only and based on investigator's clinical judgment to decide which subjects complete them.
The Generalized Anxiety Disorder 7 (GAD-7) is a 7-item self-reported questionnaire for screening and severity measuring of generalized anxiety disorder (GAD). GAD-7 has seven items and uses a normative system of scoring. Assessment is indicated by the total score, which made up by adding together the scores for the scale all seven items.
Measured: through study completion, an average of 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2017
- Study start14 Dec 2017
- Primary completion1 Dec 2029 (estimated)
- Study completion1 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Treatment Resistant 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- LivaNova
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Koen Demyttenaere, Prof., Principal investigator, KU LeuvenAllan Young, Prof., Principal investigator, King's College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03320304
- Sponsor's protocol ID
- LNN800
- Acronym
- RESTORE-LIFE
- Status last verified
- Aug 2026
- First submitted
- 5 Oct 2017
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Kavakbasi E, Kraus C, Reif-Leonhard C, Blackwell JM, Dibue M, Treiber M, Achten S, Baune BT. Titration of vagus nerve stimulation for difficult-to-treat depression and onset of response: Early insights from the RESTORE-LIFE study. J Affect Disord. 2025 Jun 1;378:39-46. doi: 10.1016/j.jad.2025.02.047. Epub 2025 Feb 26.
PubMed 40021060Kavakbasi E, Baune BT. Combination of Acute and Maintenance Esketamine Treatment With Adjunctive Long-Term Vagus Nerve Stimulation in Difficult-to-Treat Depression. Neuromodulation. 2024 Jun;27(4):766-773. doi: 10.1016/j.neurom.2023.12.004. Epub 2024 Feb 10.
PubMed 38340111Kavakbasi E, Rosemann K, Yilmaz M, Vasileiadou A, Falcone V, Baune BT. Vagus Nerve Stimulation Combined With Alternating Synchronized and Nonsynchronized Intermittent Theta Burst Stimulation in Difficult-to-Treat Depression. J ECT. 2024 Mar 1;40(1):62-63. doi: 10.1097/YCT.0000000000000964. Epub 2023 Dec 28. No abstract available.
PubMed 38194603Young AH, Juruena MF, De Zwaef R, Demyttenaere K. Vagus nerve stimulation as adjunctive therapy in patients with difficult-to-treat depression (RESTORE-LIFE): study protocol design and rationale of a real-world post-market study. BMC Psychiatry. 2020 Sep 29;20(1):471. doi: 10.1186/s12888-020-02869-6.
PubMed 32993573
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Global PRospective, Multi-cEnter, ObServational Post-markeT Study tO Assess shoRt, Mid and Long-term Effectiveness and Efficiency of VNS Therapy® as Adjunctive Therapy in reaL-world patIents With diFficult to Treat dEpression.
- ClinicalTrials.gov ID
- NCT03320304
- Acronym / sponsor ID
- RESTORE-LIFE / LNN800
- Conditions
- Treatment Resistant Depression
- Keywords
- Difficult to Treat Depression, TRD, VNS Therapy, Vagus Nerve Stimulation, VNS
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- LivaNovaIndustry (pharma, biotech, devices)
- Study start
- 14 Dec 2017 (actual)
- Primary completion
- 1 Dec 2029 (estimated)
- Study completion
- 1 Dec 2031 (estimated)
- First posted
- 25 Oct 2017 (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.
The primary objective of this study is to assess short, mid and long-term clinical outcomes in patients with difficult to treat depression (such as patients with treatment resistant depression) treated with Vagus Nerve Stimulation (VNS) Therapy as adjunctive therapy.
Detailed description
The population under study comprises a real-world patient population with difficult to treat depression: patients diagnosed with unipolar or bipolar disorder with chronic or recurrent depression who fail to achieve an adequate response to standard psychiatric management.
The diagnosis of depression and comorbid disorders will be determined based on the Mini International Neuropsychiatric Interview (MINI).
A minimum of five hundred (500) patients will be implanted with a VNS Therapy System and up to eighty (80) sites may participate in this study.
Enrollment will take 11 years, based on competitive enrollment. For each subject a baseline visit will occur between 1 and 6 weeks before implant.
Once implanted with the device, subjects will be followed-up for a minimum of 36 months and a maximum of 60 months. The study may stop when the last subject has reached the 36 months follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vagal Nerve Simulation (VNS) Therapy | – | Device: Vagal Nerve Simulation (VNS) TherapyThe aim of this study is to include patients with difficult to treat depression from a global "real world" (standard of care) population who are referred for treatment with VNS Therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population under study comprises a real-world patient population with difficult to treat depression: patients diagnosed with unipolar or bipolar disorder with chronic or recurrent depression who fail to achieve an adequate response to standard psychiatric management. The diagnosis of depression and comorbid disorders will be determined based on the Mini International Neuropsychiatric Interview (MINI).
Key inclusion criteria (5 listed)
- Be at least 18 years of age.
- Have a documented primary diagnosis of chronic (>2 years) or recurrent (2 or more prior episodes) major depressive episode that has not adequately responded to an adequate number of antidepressant treatments, as per local medical standards. This diagnosis must be confirmed using the MINI.
- Provide written Ethics Committee (EC) or Institutional Review Board (IRB) approved informed consent and Health Insurance Portability and Accountability Act (HIPAA, US only) authorization (as applicable according to local requirements).
- Currently is receiving at least one antidepressant treatment (i.e., antidepressant drug, maintenance electroconvulsive therapy, or formal psychotherapy including supportive psychotherapy) or mood stabilizing treatment for bipolar patients (such as lithium, anticonvulsants, or atypical antipsychotics).
- Able and willing to comply with the frequency of (outpatient) clinic visits and to reliably complete all the evaluations as specified in the study protocol.Hence based on the nature of their disease, the following patients should not be included: patients with mental retardation, current severe or significant substance/alcohol abuse, diagnosis of one or more schizophrenia-spectrum or other psychotic disorders, diagnosis of borderline or severe personality disorder as determined by clinical judgment which, in the investigator's opinion, would significantly interfere with subject's participation in the study)
Key exclusion criteria (1 listed)
- There are no exclusion criteria; the investigator should refer to the (local applicable) VNS Therapy Physician's Manual.
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 |
|---|---|---|
| Vagal Nerve Simulation (VNS) TherapyA VNS Therapy System used for vagus nerve stimulation and consisting of an implantable VNS Therapy generator, lead, and external programming system. | Device | Vagal Nerve Simulation (VNS) Therapy |
Primary outcome
The primary endpoint of this study is response defined as reduction in Montgomery Åsberg Depression Rating Scale (MADRS) total score of at least 50% from baseline to 12 months post implant.
Time frame: 12 months
MADRS is a 10-item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. Each item yields a score of 0 to 6. The overall score ranges from 0 to 60. Higher MADRS score indicates more severe depression. A 'Responder' is a subject that achieved ≥ 50% reduction from baseline in MADRS total score at the M12 assessment. A 'Non-Responder' is any patient who did not achieve ≥ 50% reduction from baseline in MADRS score at the M12 assessment. No formal hypothesis testing is presented; all the proposed statistical tests are descriptive in nature. The Primary endpoint analysis as defined above will be done only on patients that are enrolled while in a major depressive episode (MDE); the cut off point for current MDE at time of implant will be a MADRS score of 20. For the patients with a MADRS score below 20 at time of enrollment, only the continuous change in MADRS can be described (as the MADRS can only worsen or stay the same).
16 secondary outcomes
Duration of response
Time frame: through study completion, an average of 4 years
Change in MADRS
Time frame: through study completion, an average of 4 years
Cumulative response
Time frame: through study completion, an average of 4 years
Cumulative remission
Time frame: through study completion, an average of 4 years
Changes in depression score As measured by the Quick Inventory of Depressive Symptomatology Self-Report (QIDS-SR).
Time frame: through study completion, an average of 4 years
Changes in mania score as measured by the Altman Self-Rating Mania Scale (ASRM)*.
Time frame: through study completion, an average of 4 years
Changes in Quality of Life as measured by the EuroQol five dimensions questionnaire (EQ-5D-5L)
Time frame: through study completion, an average of 4 years
Changes in patient function as measured by the Work Productivity and Activity Impairment Scale (WPAI)
Time frame: through study completion, an average of 4 years
Changes in Quality of Life and patient function as measured by the Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF)
Time frame: through study completion, an average of 4 years
Changes in suicidality as measured by item #10 of MADRS.
Time frame: through study completion, an average of 4 years
Changes in suicidality as measured by item #12 of QIDS-SR.
Time frame: through study completion, an average of 4 years
Changes in adjunctive antidepressant pharmacological treatment
Time frame: through study completion, an average of 4 years
Changes in adjunctive antidepressant non-pharmacological treatment
Time frame: through study completion, an average of 4 years
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: through study completion, an average of 4 years
Changes in cognition
Time frame: through study completion, an average of 4 years
Changes in anxiety as measured by the Generalized Anxiety Disorder Assessment (GAD 7)*.
Time frame: through study completion, an average of 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Derived from this study: PubMed 40021060Kavakbasi E, Kraus C, Reif-Leonhard C, Blackwell JM, Dibue M, Treiber M, Achten S, Baune BT. Titration of vagus nerve stimulation for difficult-to-treat depression and onset of response: Early insights from the RESTORE-LIFE study. J Affect Disord. 2025 Jun 1;378:39-46. doi: 10.1016/j.jad.2025.02.047. Epub 2025 Feb 26.
- Derived from this study: PubMed 38340111Kavakbasi E, Baune BT. Combination of Acute and Maintenance Esketamine Treatment With Adjunctive Long-Term Vagus Nerve Stimulation in Difficult-to-Treat Depression. Neuromodulation. 2024 Jun;27(4):766-773. doi: 10.1016/j.neurom.2023.12.004. Epub 2024 Feb 10.
- Derived from this study: PubMed 38194603Kavakbasi E, Rosemann K, Yilmaz M, Vasileiadou A, Falcone V, Baune BT. Vagus Nerve Stimulation Combined With Alternating Synchronized and Nonsynchronized Intermittent Theta Burst Stimulation in Difficult-to-Treat Depression. J ECT. 2024 Mar 1;40(1):62-63. doi: 10.1097/YCT.0000000000000964. Epub 2023 Dec 28. No abstract available.
- Derived from this study: PubMed 32993573Young AH, Juruena MF, De Zwaef R, Demyttenaere K. Vagus nerve stimulation as adjunctive therapy in patients with difficult-to-treat depression (RESTORE-LIFE): study protocol design and rationale of a real-world post-market study. BMC Psychiatry. 2020 Sep 29;20(1):471. doi: 10.1186/s12888-020-02869-6.
- Individual participant dataSharing planned: No
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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.
Gaia Giannicola contact
Koen Demyttenaere, Prof. principal investigator
KU Leuven
Allan Young, Prof. principal investigator
King's College
18 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Treatment Resistant Depression, run by LivaNova at 18 sites in 4 countries.
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 5 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Germany, United Kingdom, Austria, Belgium. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Funda Basdar (+32 473 97 49 41, funda.basdar@livanova.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary endpoint of this study is response defined as reduction in Montgomery Åsberg Depression Rating Scale (MADRS) total score of at least 50% from baseline to 12 months post implant. (time frame: 12 months). 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 NCT03320304, which also lists 4 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 27 Aug 2026.