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Pivotal Trial (D02) of Vagus Nerve Stimulation (VNS) for Treatment-Resistant Depression (TRD) | Clinical Trials | Clareo Health

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

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

NCT00533832•Cyberonics, Inc.

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

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.
+3 more criteria

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 more criteria

Locations (1)

Houston, Texas, United States

Key Dates

Start Date

July 1, 2000

Completion Date

July 1, 2005

Last Updated

September 24, 2007

Enrollment

266

ACTUAL participants

Conditions

Major Depressive Disorder

Interventions

vagus nerve stimulation (VNS)

DEVICE

A Phase 2 Study of Zelquistinel or Placebo for the Reduction of Symptoms of Major Depressive Disorder

NCT07115329

Major Depressive Disorder

View study

RECRUITINGPHASE3

A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder

NCT06793397

Major Depressive Disorder (MDD)Depression in Adults+4 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 24, 2007Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Phase 2 Study of Zelquistinel or Placebo for the Reduction of Symptoms of Major Depressive Disorder

A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder

Accelerated Intermittent Theta Burst Stimulation for Adolescent and Young Adult Depression With Elevated Suicide Risk

Validating the On-line Creyos Cognitive Assessment Platform in Older Adults With Major Depressive Disorder or Mild Cognitive Impairment

University of Iowa Interventional Psychiatry Service Patient Registry

Preliminary Efficacy Trial of a Digital Intervention for Depression and Cannabis Use