NCT00305565

Brief Summary

This is a postmarket medical device study. The objective of this study is to compare the safety and effectiveness of Vagus Nerve Stimulation (VNS) Therapy administered at different amounts of electrical charge for the treatment of patients with treatment-resistant depression (TRD).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
331

participants targeted

Target at P75+ for phase_4 depression

Timeline
Completed

Started Jan 2006

Typical duration for phase_4 depression

Geographic Reach
1 country

26 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 20, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 22, 2006

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
3.1 years until next milestone

Results Posted

Study results publicly available

February 25, 2013

Completed
Last Updated

January 7, 2014

Status Verified

December 1, 2013

Enrollment Period

4.1 years

First QC Date

March 20, 2006

Results QC Date

January 6, 2011

Last Update Submit

December 6, 2013

Conditions

Depression

Keywords

DepressionChronic DepressionBipolar Disorder

Outcome Measures

Primary Outcomes (1)

  • Inventory of Depressive Symptomatology-Clinician Administered (IDS-C) Mean Change From Baseline to Week 22 of the Acute Phase (ITT Population).

    The 30-item Inventory of Depressive Symptomatology (IDS-C/SR) (Rush et al. 1986, 1996) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 84. Higher values are considered to be worse outcomes.

    From Baseline to Study Week 22

Secondary Outcomes (35)

  • Inventory of Depressive Symptomatology-Clinician Administered (IDS-C) Percent Responders From Baseline to Week 22 of the Acute Phase (ITT Population).

    From baseline to Study Week 22

  • Inventory of Depressive Symptomatology-Clinician Administered (IDS-C) Percent Remitters From Baseline to Week 22 of the Acute Phase (ITT Population).

    From baseline to Study Week 22

  • Inventory of Depressive Symptomatology-Clinician Administered (IDS-C) Percent Responders From Baseline to Week 50 of the Long-term Phase (ITT Population).

    From baseline to Study Week 50

  • Inventory of Depressive Symptomatology-Clinician Administered (IDS-C) Percent Sustained Responders at Study Week 50 (ITT Population).

    From baseline to Study Week 50

  • Inventory of Depressive Symptomatology-Clinician Administered (IDS-C) Percent Remitters From Baseline to Week 50 of the Long-term Phase (ITT Population).

    From baseline to Study Week 50

  • +30 more secondary outcomes

Study Arms (3)

Low Dose

OTHER
Device: VNS Therapy

Medium Dose

OTHER
Device: VNS Therapy

High Dose

OTHER
Device: VNS Therapy

Interventions

VNS TherapyDEVICE

Received output current of 0.25 milliamps (mA)

Also known as: VNS Therapy System
Low Dose

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient has a diagnosis of chronic or recurrent depression and is currently experiencing a major depressive episode.
  • Patient has not had an adequate response to four or more adequate antidepressant treatments from at least two different antidepressant treatment categories.
  • Patient has (in the investigator's judgment) sufficient impairment from his/her depression and/or depression treatment that the potential benefits/risks of VNS Therapy are warranted.
  • Patient must currently be receiving at least one antidepressant treatment; the patient must be receiving all current antidepressant treatments in a stable regimen.
  • If the patient has a current diagnosis of bipolar disorder, the patient must be receiving a mood stabilizer.
  • Patient must be 18 years of age or older and of legal age of consent.
  • Patient must be able to complete the evaluations specified in the study procedures flow chart.
  • Patient must provide written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization.

You may not qualify if:

  • Patient has had a bilateral or left cervical vagotomy.
  • Patient currently uses, or is expected to use during the study, short-wave diathermy, microwave diathermy, or therapeutic ultrasound diathermy.
  • A VNS Therapy System implant would pose an unacceptable surgical or medical risk for the patient.
  • Patient is expected to require full body magnetic resonance imaging during the clinical study.
  • Patient is acutely suicidal.
  • Patient has a history of schizophrenia, schizoaffective disorder, or other psychotic disorder or a current major depressive episode that includes psychotic features (commonly referred to as psychotic depression).
  • Patient has a history of rapid cycling bipolar disorder or a current diagnosis of bipolar disorder mixed phase.
  • Patient has a history of borderline personality disorder.
  • Patient has a history of drug or alcohol dependence within the 12 months prior to the baseline visit or currently takes a narcotic drug five or more days per week.
  • Patient is currently enrolled in another investigational study.
  • Patient has had a prior VNS Therapy System implant.
  • Note: Some IRBs may require additional conditions for enrollment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (26)

University of Arizona

Tucson, Arizona, 85724, United States

Location

Sutter Institute for Medical Research

Sacramento, California, 95816, United States

Location

Northwest Behavioral Research Center

Marietta, Georgia, 30060, United States

Location

Evanston Northwestern Hospital

Evanston, Illinois, 60201, United States

Location

Clinical Research Institute

Wichita, Kansas, 67211, United States

Location

Brentwood Research Institute

Shreveport, Louisiana, 71101, United States

Location

Sheppard Pratt Hospital

Baltimore, Maryland, 21204, United States

Location

Pharmasite Research Inc.

Baltimore, Maryland, 21208, United States

Location

Massachusetts General Hospital

Charlestown, Massachusetts, 02129, United States

Location

Psychiatric Recovery

Saint Paul, Minnesota, 55114, United States

Location

St. Louis University

St Louis, Missouri, 63104, United States

Location

Dent Neurologic Institute

Amherst, New York, 14226, United States

Location

Eastside Comprehensive Medical Center

New York, New York, 10021, United States

Location

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

SUNY Upstate Medical University

Syracuse, New York, 13210, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Butler Hospital

Providence, Rhode Island, 02906, United States

Location

Community Clinical Research, Inc.

Austin, Texas, 78756, United States

Location

UT Southwestern Medical Center

Dallas, Texas, 75235-8898, United States

Location

Claghorn-Lesem Research Clinic, LTD

Houston, Texas, 77401, United States

Location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

University of Utah

Salt Lake City, Utah, 84132-2502, United States

Location

Center for Anxiety and Depression

Mercer Island, Washington, 98040, United States

Location

Related Publications (7)

  • Kessler RC, Berglund P, Demler O, Jin R, Koretz D, Merikangas KR, Rush AJ, Walters EE, Wang PS; National Comorbidity Survey Replication. The epidemiology of major depressive disorder: results from the National Comorbidity Survey Replication (NCS-R). JAMA. 2003 Jun 18;289(23):3095-105. doi: 10.1001/jama.289.23.3095.

    PMID: 12813115BACKGROUND

  • Murray CJ, Lopez AD. Evidence-based health policy--lessons from the Global Burden of Disease Study. Science. 1996 Nov 1;274(5288):740-3. doi: 10.1126/science.274.5288.740. No abstract available.

    PMID: 8966556BACKGROUND

  • Geddes LA, Baker LE: Principles of Applied Biomedical Instrumentation, third edition. New York; John Wiley & Sons, 1989; 458-461.

    BACKGROUND

  • 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: 16139581BACKGROUND

  • 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: 16139582BACKGROUND

  • 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: 16139580BACKGROUND

  • Aaronson ST, Carpenter LL, Conway CR, Reimherr FW, Lisanby SH, Schwartz TL, Moreno FA, Dunner DL, Lesem MD, Thompson PM, Husain M, Vine CJ, Banov MD, Bernstein LP, Lehman RB, Brannon GE, Keepers GA, O'Reardon JP, Rudolph RL, Bunker M. Vagus nerve stimulation therapy randomized to different amounts of electrical charge for treatment-resistant depression: acute and chronic effects. Brain Stimul. 2013 Jul;6(4):631-40. doi: 10.1016/j.brs.2012.09.013. Epub 2012 Oct 23.

    PMID: 23122916RESULT

MeSH Terms

Conditions

DepressionBipolar Disorder

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorBipolar and Related DisordersMood DisordersMental Disorders

Results Point of Contact

Title
Mark Bunker Sr. Director, Global Medical Affairs
Organization
Cyberonics Inc.
Mark.Bunker@cyberonics.com
281-228-7223

Study Officials

  • Mark Bunker, PharmD

    Cyberonics, Inc.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2006

First Posted

March 22, 2006

Study Start

January 1, 2006

Primary Completion

February 1, 2010

Study Completion

February 1, 2010

Last Updated

January 7, 2014

Results First Posted

February 25, 2013

Record last verified: 2013-12

Locations

US(26)