NCT03320304 A Study to Assess Effectiveness and Efficiency of VNS Therapy in Patients With Difficult to Treat Depression.
| NCT ID | NCT03320304 |
| Status | Recruiting |
| Phase | — |
| Sponsor | LivaNova |
| Condition | Treatment Resistant Depression |
| Study Type | OBSERVATIONAL |
| Enrollment | 500 participants |
| Start Date | 2017-12-14 |
| Primary Completion | 2029-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 500 participants in total. It began in 2017-12-14 with a primary completion date of 2029-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * 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) Exclusion Criteria: There are no exclusion criteria; the investigator should refer to the (local applicable) VNS Therapy Physician's Manual.
Contact & Investigator
Koen Demyttenaere, Prof.
PRINCIPAL INVESTIGATOR
KU Leuven
Frequently Asked Questions
Who can join the NCT03320304 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Treatment Resistant Depression. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03320304 currently recruiting?
Yes, NCT03320304 is actively recruiting participants. Contact the research team at funda.basdar@livanova.com for enrollment information.
Where is the NCT03320304 trial being conducted?
This trial is being conducted at Vienna, Austria, Leuven, Belgium, Bamberg, Germany, Bonn, Germany and 11 additional locations.
Who is sponsoring the NCT03320304 clinical trial?
NCT03320304 is sponsored by LivaNova. The principal investigator is Koen Demyttenaere, Prof. at KU Leuven. The trial plans to enroll 500 participants.
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