Study Comparing Outcomes for Patients With Treatment Resistant Depression Who Receive VNS Therapy at Different Doses - Full Text View

Sponsor:	Cyberonics, Inc.
Information provided by:	Cyberonics, Inc.
ClinicalTrials.gov Identifier:	NCT00305565

Purpose

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).

Condition	Intervention	Phase
Depression	Device: VNS Therapy	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Randomized Comparison of Outcomes in Patients With Treatment-Resistant Depression Who Receive VNS Therapy Administered at Different Amounts of Electrical Charge

Resource links provided by NLM:

MedlinePlus related topics: Depression

U.S. FDA Resources

Further study details as provided by Cyberonics, Inc.:

Primary Outcome Measures:

The primary efficacy endpoint is the mean IDS-C change from baseline over weeks 10, 14, 18, and 22 of the Acute Phase. [ Time Frame: From Baseline to Study Week 22 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The three key secondary efficacy endpoints are the mean changes from baseline in the QIDS-C, MADRS, and IDS-SR (LOCF) scores over weeks 10, 14, 18, and 22 of the Acute Phase. [ Time Frame: From Baseline to Study Week 22 ] [ Designated as safety issue: No ]

Enrollment:	330
Study Start Date:	January 2006
Study Completion Date:	February 2010
Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 Subject receives VNS Therapy at 1 randomly assigned electrical charge setting	Device: VNS Therapy
2 Subject receives VNS Therapy at a different randomly assigned electrical charge setting	Device: VNS Therapy
3 Subject receives VNS Therapy at a different randomly assigned electrical charge setting	Device: VNS Therapy

Detailed Description:

This is a postmarket medical device study. This study will examine treatment outcomes for patients with TRD who are randomized to VNS Therapy administered at different amounts of electrical charge. The Sponsor, Cyberonics, provides funding for this study. Patients are followed for 54 weeks, 50 of those weeks are following implantation of the VNS Therapy system. No study sites will be permitted to enroll study subjects until Institutional Review Board (IRB) approval has been received. Sites are permitted to be approved by a local or a central IRB.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00305565

Show 26 Study Locations

Sponsors and Collaborators

Cyberonics, Inc.

Investigators

Study Director:

Mark Bunker, PharmD

Cyberonics, Inc.

More Information

Publications:

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.

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

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

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.

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.

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.

Responsible Party:	Mark Bunker, Study Director, Cyberonics
ClinicalTrials.gov Identifier:	NCT00305565 History of Changes
Other Study ID Numbers:	D-21-US
Study First Received:	March 20, 2006
Last Updated:	May 20, 2010
Health Authority:	United States: Institutional Review Board

Keywords provided by Cyberonics, Inc.:

Depression
Chronic Depression
Bipolar Disorder

Additional relevant MeSH terms:

Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on February 02, 2012