Health TrialsbyHealthPanel

A Prospective, Multi-center, Randomized Controlled Blinded Trial Demonstrating the Safety and Effectiveness of VNS Therapy® System as Adjunctive Therapy Versus a No Stimulation Control in Subjects With Treatment-Resistant Depression

ConditionTreatment Resistant Depression
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorLivaNova

About this trial

Objectives of this study are to determine whether active VNS Therapy treatment is superior to a no stimulation control in producing a reduction in baseline depressive symptom severity, based on multiple depression scale assessment tools at 12 months from randomization.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Vagus Nerve Stimulation (VNS)

    Device

    VNS is an implantable device that delivers stimulation to the vagal nerve.

Treatment groups

6,800 Participants
are divided into 2 treatment groups
Group A: ActiveActive comparator 1 intervention
Group B: ControlSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Montgomery Åsberg Depression Rating Scale (MADRS) Rate of Response

The rate of response defined as person months of response/total months of study participation where response is at least a 50% reduction from baseline in MADRS total score. Subjects discontinuing the study before the endpoint assessment will be considered as non-responders for each successive month after discontinuance.

Time frame
12 months post randomization
2

Montgomery Åsberg Depression Rating Scale (MADRS) Time to First response

Time from randomization to the first observed MADRS response.

Time frame
Baseline up to 12 Months
3

Montgomery Åsberg Depression Rating Scale (MADRS) Time to First Remission

Time from randomization to the first observed MADRS remission.

Time frame
Baseline up to 12 Months
4

Montgomery Åsberg Depression Rating Scale (MADRS) Duration of Response

Duration of MADRS response, defined as the number of consecutive months from first observed MADRS response to the first assessment of MADRS response relapse.

Time frame
Baseline up to 12 Months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

LivaNova

Lead sponsor

Source ClinicalTrials.gov
Apply now