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

NCT00533832 | Completed DMC

• 1 other identifier: D02
• Study Type: interventional
• Target: 266
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Major Depressive Disorder

Keywords

depression; vagus nerve stimulation

Study Arms (2)

1

ACTIVE COMPARATOR

Patients implanted with the vagus nerve stimulation (VNS) device and receiving VNS Intervention: vagus nerve stimulation (VNS)

Device: vagus nerve stimulation (VNS)

2

PLACEBO COMPARATOR

Implanted with vagus nerve stimulation (VNS) device, but not receiving VNS

Device: vagus nerve stimulation (VNS)

Interventions

vagus nerve stimulation (VNS) DEVICE

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

1; 2

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosed with major depressive episode (MDE)
• chronic (\>=2 years)or recurrent (\>-=4) lifetime MDEs
• resistant to \>=2 treatments from different categories
• completed \>=6 weeks of psychotherapy
• score \>=20 on 24-item Hamilton Rating Scale of Depression
• IQ \>=70
• stable on current antidepressant medication (no more than 5 antidepressant meds) or taking no antidepressant meds for \>=4 weeks before Visit B1
• stable on atypical antipsychotic and anticonvulsant medications as for item #7
• age \>=18 amd \<=80 years
• male or nonpregnant female adequately protected from conception.
• able to comply with testing and follow-up visits
• voluntarily signed informed consent
• 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)

You may not qualify if:

• atypical depression at study entry or psychotic symptoms in any MDE
• history of schizophrenia, schizoaffective disorder, or delusional disorders
• rapid cycling bopolar disorder
• secondary diagnosis of, or signs of, delirium, dementia, amnestic, or other cognitive disorders
• failed 7 or more antidepressant treatments
• 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
• alcohol or substance dependence within previous 12 months or abuse within previous 6 mon other than nicotine dependence or abuse
• history of myocardial infarction or cardiac arrest
• other progressive neurological disease, significant central nervous system disease or injury, or cervical fracture that makes implantation difficult
• received general anesthesia with 390 days before enrollment.
• 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
• enrolled in another investigational study
• using another investigational device
• significant cardiac or pulmonary condition currently under treatment resulting in an ASA score \>=III
• 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

Sponsors & Collaborators

• Cyberonics, Inc.: lead

Study Sites (1)

Unknown Facility

Houston, Texas, United States

Location

Related Publications (5)

• 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 treatment-resistant depression. Biol Psychiatry. 2005 Sep 1;58(5):364-73. doi: 10.1016/j.biopsych.2005.07.028.

  PMID: 16139582 RESULT

• 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 depression: a naturalistic study. Biol Psychiatry. 2005 Sep 1;58(5):355-63. doi: 10.1016/j.biopsych.2005.05.024.

  PMID: 16139581 RESULT

• 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 randomized, controlled acute phase trial. Biol Psychiatry. 2005 Sep 1;58(5):347-54. doi: 10.1016/j.biopsych.2005.05.025.

  PMID: 16139580 RESULT

• Cohen LJ, Allen JC Jr. Estimating the potential savings with vagus nerve stimulation for treatment-resistant depression: a payer perspective. Curr Med Res Opin. 2008 Aug;24(8):2203-17. doi: 10.1185/03007990802229050.

  PMID: 18786301 DERIVED

• Nierenberg AA, Alpert JE, Gardner-Schuster EE, Seay S, Mischoulon D. Vagus nerve stimulation: 2-year outcomes for bipolar versus unipolar treatment-resistant depression. Biol Psychiatry. 2008 Sep 15;64(6):455-60. doi: 10.1016/j.biopsych.2008.04.036. Epub 2008 Jun 24.

  PMID: 18571625 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Interventions

Vagus Nerve Stimulation

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics

Study Officials

• Investigator

  Cyberonics, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 20, 2007
• First Posted: September 24, 2007
• Study Start: July 1, 2000
• Study Completion: July 1, 2005
• Last Updated: September 24, 2007

Record last verified: 2007-09

Locations

US (1)