DBS of the Lateral Habenula in Treatment-Resistant Depression

NAActive, not recruitingINTERVENTIONAL
Enrollment

6

Participants

Timeline

Start Date

February 28, 2013

Primary Completion Date

August 31, 2025

Study Completion Date

August 31, 2025

Conditions
Treatment Resistant Major Depressive Disorder
Interventions
DEVICE

Activa Tremor Control Sys (DBS Implant)

DBS system consists of the Activa RC 37612 System (Implantable Pulse Generator with Model 37085 Extensions (40 to 95cm), Activa Patient Programmer, and Medtronic Model 3389 DBS Lead). This system is commercially approved for the treatment of chronic, intractable Parkinson's Disease. It will be used with the Model SP-10344 Memory Mod Software which enables the physician to program the Implantable Pulse Generator to a higher frequency.

OTHER

Randomized, staggered withdrawal phase

For responders only: double blind discontinuation will be attempted on either the 12 or 13 month visit. Stimulation intensity will be decreased by 50% and then completely discontinued two weeks later. Subjects will be seen biweekly until 15 months post activation or escape criteria are met. These escape criteria include relapse at 2 visits, hospitalization, active suicidal ideation, or withdrawing consent. If any of these criteria are met, the blind will be broken and open treatment will be resumed.

Trial Locations (1)

77030

Baylor College of Medicine, Houston

All Listed Sponsors
lead

Wayne Goodman MD

OTHER

NCT01798407 - DBS of the Lateral Habenula in Treatment-Resistant Depression | Biotech Hunter | Biotech Hunter