Study Comparing Outcomes for Patients With Treatment Resistant Depression Who Receive VNS Therapy at Different Doses
Condition: Depression
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Treatment-Resistant
Intervention: VNS Therapy; VNS Therapy; VNS Therapy
Intervention description: Received output current of 0.25 milliamps (mA); Received output current of 0.5-1.0 mA; Received output current of 1.0-1.5 mA
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 331.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Depression; Chronic Depression; Bipolar Disorder

Summary:

      This is a postmarket medical device study. The objective of this study is to compare the
      safety and effectiveness of Vagus Nerve Stimulation (VNS) Therapy administered at different
      amounts of electrical charge for the treatment of patients with treatment-resistant
      depression (TRD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient has a diagnosis of chronic or recurrent depression and is currently
             experiencing a major depressive episode.

          -  Patient has not had an adequate response to four or more adequate antidepressant
             treatments from at least two different antidepressant treatment categories.

          -  Patient has (in the investigator's judgment) sufficient impairment from his/her
             depression and/or depression treatment that the potential benefits/risks of VNS
             Therapy are warranted.

          -  Patient must currently be receiving at least one antidepressant treatment; the patient
             must be receiving all current antidepressant treatments in a stable regimen.

          -  If the patient has a current diagnosis of bipolar disorder, the patient must be
             receiving a mood stabilizer.

          -  Patient must be 18 years of age or older and of legal age of consent.

          -  Patient must be able to complete the evaluations specified in the study procedures
             flow chart.

          -  Patient must provide written informed consent and Health Insurance Portability and
             Accountability Act (HIPAA) authorization.

        Exclusion Criteria:

          -  Patient has had a bilateral or left cervical vagotomy.

          -  Patient currently uses, or is expected to use during the study, short-wave diathermy,
             microwave diathermy, or therapeutic ultrasound diathermy.

          -  A VNS Therapy System implant would pose an unacceptable surgical or medical risk for
             the patient.

          -  Patient is expected to require full body magnetic resonance imaging during the
             clinical study.

          -  Patient is acutely suicidal.

          -  Patient has a history of schizophrenia, schizoaffective disorder, or other psychotic
             disorder or a current major depressive episode that includes psychotic features
             (commonly referred to as psychotic depression).

          -  Patient has a history of rapid cycling bipolar disorder or a current diagnosis of
             bipolar disorder mixed phase.

          -  Patient has a history of borderline personality disorder.

          -  Patient has a history of drug or alcohol dependence within the 12 months prior to the
             baseline visit or currently takes a narcotic drug five or more days per week.

          -  Patient is currently enrolled in another investigational study.

          -  Patient has had a prior VNS Therapy System implant.

        Note: Some IRBs may require additional conditions for enrollment.