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Pivotal Trial (D02) of Vagus Nerve Stimulation (VNS) for Treatment-Resistant Depression (TRD)

NCT00533832 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 266

Last updated 2007-09-24

No results posted yet for this study

Summary

To confirm the safety and efficacy of the NCP System in treating patients in a nmajor depressive episode.

Conditions

Interventions

DEVICE

vagus nerve stimulation (VNS)

intermittent vagus nerve stimulation Placebo group were implanted, but did not receive vagus nerve stimulation during the acute phase.

Sponsors & Collaborators

  • Cyberonics, Inc.

    lead INDUSTRY

Principal Investigators

  • Investigator · Cyberonics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2000-07-31
Completion
2005-07-31

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 NCT00533832 on ClinicalTrials.gov