Major Depressive DisorderNCT00533832
Pivotal Trial (D02) of Vagus Nerve Stimulation (VNS) for Treatment-Resistant Depression (TRD)
A study testing vagus nerve stimulation (VNS) in people with Major Depressive Disorder, run by Cyberonics, Inc. at 1 site in United States.
Trial summary
To confirm the safety and efficacy of the NCP System in treating patients in a nmajor depressive episode. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- vagus nerve stimulation (VNS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 266 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2000to Jul 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 13Show fewer
- 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)
Who cannot join
- 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
Show all 21Show fewer
- 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
- unilateral or bilateral cervical vagotomy
- demand cardiac pacemaker, implantable defibrillator, or other implantable stimulator
- likely to require a whole body MRI after NCP implantation
- currently receiving or likely to receive short-wave diathermy, microwave diathermy, or therapeutic ultrasound diathermy after implantation
- plans to relocate or move to a location distant from the study site within one year of enrollment
- previously enrolled in this or any other NCP System study -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicernter, Pivotal, Safety and Efficacy Study of the NeuroCtybernetic Prosthesis (NCP(R)) System in Patients With Depression
To confirm the safety and efficacy of the NCP System in treating patients in a nmajor depressive episode.
- Conditions
- Major Depressive Disorder
- Being tested
- vagus nerve stimulation (VNS)
- Keywords
- depression, vagus nerve stimulation
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vagus nerve stimulation (VNS)Device
intermittent vagus nerve stimulation
Placebo group were implanted, but did not receive vagus nerve stimulation during the acute phase.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Patients implanted with the vagus nerve stimulation (VNS) device and receiving VNS Intervention: vagus nerve stimulation (VNS) Receives: Device: vagus nerve stimulation (VNS) |
| 2 | Placebo comparator | Implanted with vagus nerve stimulation (VNS) device, but not receiving VNS Receives: Device: vagus nerve stimulation (VNS) |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2007 (estimated)
- Study startJul 2000
- Study completionJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 266 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cyberonics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Investigator, Study director, Cyberonics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00533832
- Sponsor's protocol ID
- D02
- Status last verified
- Sep 2007
- First submitted
- 20 Sep 2007
- Last updated
- 24 Sep 2007
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 16139582Rush 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.
PubMed 16139581Rush 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.
PubMed 16139580Cohen 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.
PubMed 18786301Nierenberg 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.
PubMed 18571625
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicernter, Pivotal, Safety and Efficacy Study of the NeuroCtybernetic Prosthesis (NCP(R)) System in Patients With Depression
- ClinicalTrials.gov ID
- NCT00533832
- Acronym / sponsor ID
- D02
- Conditions
- Major Depressive Disorder
- Keywords
- depression, vagus nerve stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 266 participants (actual)
- Lead sponsor
- Cyberonics, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2000
- Study completion
- Jul 2005 (actual)
- First posted
- 24 Sep 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To confirm the safety and efficacy of the NCP System in treating patients in a nmajor depressive episode.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: vagus nerve stimulation (VNS)Patients implanted with the vagus nerve stimulation (VNS) device and receiving VNS Intervention: vagus nerve stimulation (VNS) |
| 2 | Placebo comparator | Device: vagus nerve stimulation (VNS)Implanted with vagus nerve stimulation (VNS) device, but not receiving VNS |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vagus nerve stimulation (VNS)intermittent vagus nerve stimulation Placebo group were implanted, but did not receive vagus nerve stimulation during the acute phase. | Device | 1, 2 |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2007.
- Results publication: PubMed 16139582George 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.
- Results publication: PubMed 16139581Rush 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.
- Results publication: PubMed 16139580Rush 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.
- Derived from this study: PubMed 18786301Cohen 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.
- Derived from this study: PubMed 18571625Nierenberg 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.
Related trials for Major Depressive Disorder
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
RecruitingPhase 4
Biomarker-Guided Antidepressant Selection
Depression - Major Depressive Disorder, Treatment-resistant Depression (TRD)
Recruiting
Targeting Network Dysfunction in Apathy of Late-life Depression Using Digital Therapeutics
Major Depressive Disorder, Apathy
RecruitingObservational study
Student Precarity and Psychiatry
Depressive Disorder, Major, Generalized Anxiety Disorder
Not yet recruiting
Acute Intermittent Hypoxia Therapy for Depression
Major Depressive Disorder (MDD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Investigator study director
Cyberonics, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vagus nerve stimulation (VNS) in people with Major Depressive Disorder, run by Cyberonics, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00533832, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2007.