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

This study has been completed.
Sponsor:
Information provided by:
Cyberonics, Inc.
ClinicalTrials.gov Identifier:
NCT00533832
First received: September 20, 2007
Last updated: September 21, 2007
Last verified: September 2007
  Purpose

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


Condition Intervention
Major Depressive Disorder
Device: vagus nerve stimulation (VNS)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicernter, Pivotal, Safety and Efficacy Study of the NeuroCtybernetic Prosthesis (NCP(R)) System in Patients With Depression

Resource links provided by NLM:


Further study details as provided by Cyberonics, Inc.:

Enrollment: 266
Study Start Date: July 2000
Study Completion Date: July 2005
Arms Assigned Interventions
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.


  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 -
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00533832

Locations
United States, Texas
Houston, Texas, United States
Sponsors and Collaborators
Cyberonics, Inc.
Investigators
Study Director: Investigator Cyberonics, Inc.
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00533832     History of Changes
Other Study ID Numbers: D02
Study First Received: September 20, 2007
Last Updated: September 21, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Cyberonics, Inc.:
depression
vagus nerve stimulation

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Depressive Disorder, Treatment-Resistant
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 11, 2014