Pivotal Trial (D02) of Vagus Nerve Stimulation (VNS) for Treatment-Resistant Depression (TRD)

Study Overview
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Brief Summary
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To confirm the safety and efficacy of the NCP System in treating patients in a nmajor depressive episode.

Official Title
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A Multicernter, Pivotal, Safety and Efficacy Study of the NeuroCtybernetic Prosthesis (NCP(R)) System in Patients With Depression

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Device: vagus nerve stimulation (VNS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosed with major depressive episode (MDE) chronic (>=2 years)or recurrent (>-=4) lifetime MDEs resistant to >=2 treatments from different categories completed >=6 weeks of psychotherapy score >=20 on 24-item Hamilton Rating Scale of Depression IQ >=70 stable on current antidepressant medication (no more than 5 antidepressant meds) or taking no antidepressant meds for >=4 weeks before Visit B1 stable on atypical antipsychotic and anticonvulsant medications as for item #7 age >=18 amd <=80 years male or nonpregnant female adequately protected from conception. able to comply with testing and follow-up visits voluntarily signed informed consent patients with bipolar disorder demonstrated a resistance to lithium treatment or has a medical contraindication to treatment with lithium or is known to be intolerant to lithium (not applicable to patients with MDD) Exclusion Criteria: atypical depression at study entry or psychotic symptoms in any MDE history of schizophrenia, schizoaffective disorder, or delusional disorders rapid cycling bopolar disorder secondary diagnosis of, or signs of, delirium, dementia, amnestic, or other cognitive disorders failed 7 or more antidepressant treatments a. suicide attempt requiring medical attention within previous 12 months b. >=2 suicide attempts in the past 12 months c. cannot guarantee that will not implement suicide d. likely to attempt suicide within next 6 mon in investigator's opinion alcohol or substance dependence within previous 12 months or abuse within previous 6 mon other than nicotine dependence or abuse history of myocardial infarction or cardiac arrest other progressive neurological disease, significant central nervous system disease or injury, or cervical fracture that makes implantation difficult received general anesthesia with 390 days before enrollment. taken an investigational drug within a clearance duration of 5 x the half-life of the investigational drug or within <=4weeks before Visit B1, whichever time is greater enrolled in another investigational study using another investigational device significant cardiac or pulmonary condition currently under treatment resulting in an ASA score >=III history of, or evidence of, significant brain malformation or significant head injury or clinically apparent cerebral vascular events, or prior brain surgery such as cingulatomy unilateral or bilateral cervical vagotomy demand cardiac pacemaker, implantable defibrillator, or other implantable stimulator likely to require a whole body MRI after NCP implantation currently receiving or likely to receive short-wave diathermy, microwave diathermy, or therapeutic ultrasound diathermy after implantation plans to relocate or move to a location distant from the study site within one year of enrollment previously enrolled in this or any other NCP System study -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Patients implanted with the vagus nerve stimulation (VNS) device and receiving VNS Intervention: vagus nerve stimulation (VNS) | Device: vagus nerve stimulation (VNS)<br>* intermittent vagus nerve stimulation Placebo group were implanted, but did not receive vagus nerve stimulation during the acute phase.<br>|
| Placebo Comparator: 2<br>Implanted with vagus nerve stimulation (VNS) device, but not receiving VNS | Device: vagus nerve stimulation (VNS)<br>* intermittent vagus nerve stimulation Placebo group were implanted, but did not receive vagus nerve stimulation during the acute phase.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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depression, vagus nerve stimulation