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Study Comparing Outcomes for Patients With Treatment Resistant Depression Who Receive VNS Therapy at Different Doses

NCT00305565 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 331

Last updated 2014-01-07

Study results available
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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).

Conditions

Interventions

DEVICE

VNS Therapy

Received output current of 0.25 milliamps (mA)

DEVICE

VNS Therapy

Received output current of 0.5-1.0 mA

DEVICE

VNS Therapy

Received output current of 1.0-1.5 mA

Sponsors & Collaborators

  • Cyberonics, Inc.

    lead INDUSTRY

Principal Investigators

  • Mark Bunker, PharmD · Cyberonics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-01-31
Primary Completion
2010-02-28
Completion
2010-02-28

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00305565 on ClinicalTrials.gov