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

September 21, 2007 updated by: Cyberonics, Inc.

A Multicernter, Pivotal, Safety and Efficacy Study of the NeuroCtybernetic Prosthesis (NCP(R)) System in Patients With Depression

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

266

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. diagnosed with major depressive episode (MDE)
  2. chronic (>=2 years)or recurrent (>-=4) lifetime MDEs
  3. resistant to >=2 treatments from different categories
  4. completed >=6 weeks of psychotherapy
  5. score >=20 on 24-item Hamilton Rating Scale of Depression
  6. IQ >=70
  7. stable on current antidepressant medication (no more than 5 antidepressant meds) or taking no antidepressant meds for >=4 weeks before Visit B1
  8. stable on atypical antipsychotic and anticonvulsant medications as for item #7
  9. age >=18 amd <=80 years
  10. male or nonpregnant female adequately protected from conception.
  11. able to comply with testing and follow-up visits
  12. voluntarily signed informed consent
  13. patients with bipolar disorder demonstrated a resistance to lithium treatment or has a medical contraindication to treatment with lithium or is known to be intolerant to lithium (not applicable to patients with MDD)

Exclusion Criteria:

  1. atypical depression at study entry or psychotic symptoms in any MDE
  2. history of schizophrenia, schizoaffective disorder, or delusional disorders
  3. rapid cycling bopolar disorder
  4. secondary diagnosis of, or signs of, delirium, dementia, amnestic, or other cognitive disorders
  5. failed 7 or more antidepressant treatments
  6. a. suicide attempt requiring medical attention within previous 12 months b. >=2 suicide attempts in the past 12 months c. cannot guarantee that will not implement suicide d. likely to attempt suicide within next 6 mon in investigator's opinion
  7. alcohol or substance dependence within previous 12 months or abuse within previous 6 mon other than nicotine dependence or abuse
  8. history of myocardial infarction or cardiac arrest
  9. other progressive neurological disease, significant central nervous system disease or injury, or cervical fracture that makes implantation difficult
  10. received general anesthesia with 390 days before enrollment.
  11. taken an investigational drug within a clearance duration of 5 x the half-life of the investigational drug or within <=4weeks before Visit B1, whichever time is greater
  12. enrolled in another investigational study
  13. using another investigational device
  14. significant cardiac or pulmonary condition currently under treatment resulting in an ASA score >=III
  15. history of, or evidence of, significant brain malformation or significant head injury or clinically apparent cerebral vascular events, or prior brain surgery such as cingulatomy
  16. unilateral or bilateral cervical vagotomy
  17. demand cardiac pacemaker, implantable defibrillator, or other implantable stimulator
  18. likely to require a whole body MRI after NCP implantation
  19. currently receiving or likely to receive short-wave diathermy, microwave diathermy, or therapeutic ultrasound diathermy after implantation
  20. plans to relocate or move to a location distant from the study site within one year of enrollment
  21. previously enrolled in this or any other NCP System study -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Patients implanted with the vagus nerve stimulation (VNS) device and receiving VNS Intervention: vagus nerve stimulation (VNS)
Device: vagus nerve stimulation (VNS)

intermittent vagus nerve stimulation

Placebo group were implanted, but did not receive vagus nerve stimulation during the acute phase.
Placebo Comparator: 2
Implanted with vagus nerve stimulation (VNS) device, but not receiving VNS
Device: vagus nerve stimulation (VNS)

intermittent vagus nerve stimulation

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cyberonics, Inc.

Investigators

  • Study Director: Investigator, Cyberonics, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2000

Study Completion (Actual)

July 1, 2005

Study Registration Dates

First Submitted

September 20, 2007

First Submitted That Met QC Criteria

September 21, 2007

First Posted (Estimate)

September 24, 2007

Study Record Updates

Last Update Posted (Estimate)

September 24, 2007

Last Update Submitted That Met QC Criteria

September 21, 2007

Last Verified

September 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Major Depressive Disorder

Clinical Trials on vagus nerve stimulation (VNS)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Guatemala

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe