Tractography Guided Subcallosal Cingulate Deep Brain Stimulation for Treatment Resistant Depression
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Treatment Resistant Depression
- Undergoing Deep Brain Stimulation (DBS) Surgery
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Sequential AssignmentIntervention Model Description: There will be an initial 12-month open label period for all participants involved. In the second period of the study, patients will be divided into groups: responders (defined as a 40% reduction or more in MADRS) versus non-responders. Responders will continue to the 6-month double-blinded discontinuation phase (see below for additional details of study procedures during this phase). The non-responders, after the open label period (12 months) will have monthly follow-up visits for 12 mo. During the discontinuation period, patients will be randomized to either the ON or OFF stimulation phase for 3 mo each. If randomized to ON, there will be no change for 3 mo, then a biweekly 25% reduction in stimulation amplitude for the next 3 mo until stimulation is off. If randomization to OFF phase, there will be an initial biweekly 25% reduction in stimulation amplitude for 3 mo until the device is off then the stimulation settings will be turned back to the optimized settings for three months.Masking: None (Open Label)Masking Description: The investigators propose a clinical trial involving 12-months open-label bilateral DBS that targets SCC (using TOT) in subjects with TRD. The open label period is intended to ensure that maximal benefit can be achieved with the current proposed protocol. Following open label optimization, to control for possible placebo, each subject will enter a double blinded randomized discontinuation, intended to confirm clinical benefit of DBS among responders (6 months).Primary Purpose: Device Feasibility
Participation Requirements
- Age
- Between 21 years and 70 years
- Gender
- Both males and females
Description
Not Provided
Not Provided
Tracking Information
- NCT #
- NCT03952962
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Nader Pouratian, MD, PhD University of California, Los Angeles Principal Investigator: Randall Espinoza, MD, MPH University of California, Los Angeles
Get Well Soon