|Principal Investigator: Brian Mickey|
|Keywords: Depression||Department: Psychiatry|
|IRB Number: 00126325|
|Sub Specialties: Mood Disorders|
|Recruitment Status: Recruiting|
Vagus Nerve Stimulation (VNS) Therapy is an implanted device that delivers intermittent stimulation of the left cervical vagus nerve. VNS therapy was FDA cleared for Treatment Resistant Depression (TRD) in 2005, but Medicare has agreed to cover the costs of VNS therapy only if its efficacy is confirmed in randomized sham-controlled trial. The "RECOVER" trial has two objectives:
1. Main Study. Determine whether active VNS therapy improves health outcomes for TRD compared to a no-stimulation control with a prospective, multi-center, randomized, controlled, blinded trial.
2. Longitudinal Registry (LR) Study. If the Main Study achieves pre-defined criteria for success, then an observational, open label, single arm study will assess the long-term effectiveness and safety of VNS therapy.
Subjects must meet all of the following criteria to be considered for enrollment:
At least 18 years of age or older.
Have a current diagnosis of major depressive episode during which they have an inadequate
benefit from at least one antidepressant treatment.
Documented diagnosis of chronic (≥ 2 years) or recurrent (4 or more prior episodes, separated by
two months without meeting criteria for MDD) major depressive disorder, according to DSM 5, that has not adequately responded to at least four adequate trials of antidepressant treatment in the current episode. Antidepressant treatments: medications (must include two antidepressant medications from different classes), psychotherapy, ECT, rTMS, or pharmacological interventions. This diagnosis must be documented using the Mini-International Neuropsychiatric Interview (MINI) and include a psychiatric medical record review.
Must include a qualifying diagnosis per ICD-9 or ICD-10 codes:
MDD, Single Episode, Moderate
MDD, Single Episode, Severe
MDD, Recurrent Episode, Moderate
MDD, Recurrent Episode, Severe
Bipolar I, Current or Most Recent Episode Depressed, Moderate
Bipolar I, Current or Most Recent Episode Depressed, Severe
Have a score of at least 22 on both baseline administrations of the Montgomery-Åsberg Depression Rating Scale (MADRS), with a difference between the two scores that does not exceed 25%.
Subjects with bipolar I or II disorder must be receiving at least one mood stabilizing medication at entry into the trial.
Subject is a male or non-pregnant female adequately protected from conception. Females of childbearing potential must be willing to use an acceptable method of birth control over the entire course of the study.
Able and willing to comply with the frequency of (outpatient) clinic visits and to complete all the evaluations as specified in the study protocol.
Provide written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization.
10. Medication regimen must be stable for a minimum of 4 weeks before the baseline visit
3.5. EXCLUSION CRITERIA
Subjects who meet any of the following criteria are not eligible to be enrolled in the study:
Currently uses, or is expected to use during the study, short-wave diathermy, microwave diathermy, or therapeutic ultrasound diathermy.
An acute suicidal risk that requires inpatient treatment based on clinical judgment and history.
Suicide attempt within six months prior to baseline.
Subject has had a prior VNS Therapy or deep brain stimulation (DBS) implant.
Subject has a diagnosis of Substance Use Disorder as defined by DSM-V without sustained
remission (12 months or longer).
A history of borderline or severe personality disorder as determined by clinical judgment, which
would significantly interfere with subject’s participation in the study.
Any history of one or more schizophrenia-spectrum or other psychotic disorders including:
schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, major depressive disorder with psychosis (unipolar or bipolar), and/or psychotic depression (unipolar or bipolar) based on the MINI (does not include psychosis occurring in the context of a manic episode of a subject with bipolar disorder).
An active primary diagnosis of one or more of the following disorders: obsessive-compulsive disorder, eating disorder, or post-traumatic stress disorder based on the MINI.
Presence of any type of dementia / Major Neurocognitive Disorder.
Cognitive or psychiatric deficit (e.g. amnesia, delirium) that in the investigator’s judgment would
interfere with the subject’s ability to accurately complete study assessments
A history or diagnosis of rapid cycling bipolar disorder I or II
Current or lifetime history of psychotic features in any MDE
13. Treatment with another investigational device or investigational drugs.
A subject will be considered enrolled in the study once informed consent is obtained, all the inclusion and exclusion criteria is met at both baseline visits, and Subject Eligibility Committee approval is received.