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

Major Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00533832
• Other study ID #: D02
• Status: Completed
• Phase: N/A
• First received: September 20, 2007
• Last updated: September 21, 2007
• Start date: July 2000
• Est. completion date: July 2005

Study information

• Verified date: September 2007
• Source: Cyberonics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 266
• Est. completion date: July 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Depressive Disorder, Treatment-Resistant
• Major Depressive Disorder

Intervention

Device:
• vagus nerve stimulation (VNS)
intermittent vagus nerve stimulation Placebo group were implanted, but did not receive vagus nerve stimulation during the acute phase.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cyberonics, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (3)

George MS, Rush AJ, Marangell LB, Sackeim HA, Brannan SK, Davis SM, Howland R, Kling MA, Moreno F, Rittberg B, Dunner D, Schwartz T, Carpenter L, Burke M, Ninan P, Goodnick P. A one-year comparison of vagus nerve stimulation with treatment as usual for tr — View Citation

Rush AJ, Marangell LB, Sackeim HA, George MS, Brannan SK, Davis SM, Howland R, Kling MA, Rittberg BR, Burke WJ, Rapaport MH, Zajecka J, Nierenberg AA, Husain MM, Ginsberg D, Cooke RG. Vagus nerve stimulation for treatment-resistant depression: a randomize — View Citation

Rush AJ, Sackeim HA, Marangell LB, George MS, Brannan SK, Davis SM, Lavori P, Howland R, Kling MA, Rittberg B, Carpenter L, Ninan P, Moreno F, Schwartz T, Conway C, Burke M, Barry JJ. Effects of 12 months of vagus nerve stimulation in treatment-resistant — View Citation