CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 331 enrolled
Drug / intervention
VNS Therapy +2 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00305565
NCT00305565Phase 4Completed
CompareCT.gov

Randomized Comparison of Outcomes in Patients With Treatment-Resistant Depression Who Receive VNS Therapy Administered at Different Amounts of Electrical Charge

Cyberonics, Inc.·interventional·Posted Mar 22, 2006·Updated Jan 7, 2014

In Brief

A Phase 4 clinical trial evaluating VNS Therapy for Depression. Completed, enrolled 331 participants across 26 sites.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDepression
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 22, 2006
Enrollment StartJan 1, 2006
Primary CompletionFeb 1, 2010
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 20.3 years ago

Interventions

VNS Therapydevice

Received output current of 0.25 milliamps (mA)

VNS Therapydevice

Received output current of 0.5-1.0 mA

VNS Therapydevice

Received output current of 1.0-1.5 mA