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Outcome Measures

Primary Outcomes (1)

Change in Montgomery and Asberg Depression Rating Scale (MADRS) score.
The primary endpoint will be defined as at least a 40% reduction in the Montgomery and Asberg Depression Rating Scale (MADRS) that measures depression severity. The MADRS scores range from 0 to 60, where increased values indicate more severe depression. There are 10 questions that each yield a score of 0-6 that are then summed for a total score.
18 months

Secondary Outcomes (19)

Change in another related clinical assessment: PHQ-9
18 months
Change in another related clinical assessment: QIDS-SR
18 months
Change in another related clinical assessment: HAM-A
18 months
Change in another related clinical assessment: CSSRS
18 months
Change in another related clinical assessment: HAMD-17
18 months
+14 more secondary outcomes

Study Arms (2)

Randomized Discontinuation Period: OFF then ON DBS

EXPERIMENTAL

Subjects randomized to this arm are initially "OFF" DBS after the open label period then gradually decreased in their optimized setting's amplitude for 8 weeks and then "ON" DBS for 8 weeks.

Device: Abbott Laboratories Infinity™ implantable deep brain stimulation system

Randomized Discontinuation Period: ON then OFF DBS

EXPERIMENTAL

Subjects randomized to this arm are initially "ON" DBS with optimized stimulation settings for 8 weeks after the open label period and then "OFF" DBS with gradually decreasing amplitude for 8 weeks.

Device: Abbott Laboratories Infinity™ implantable deep brain stimulation system

Interventions

Abbott Laboratories Infinity™ implantable deep brain stimulation systemDevice

Deep brain stimulation (DBS) refers to the process of delivering an electrical current to a precise location in the brain.

Randomized Discontinuation Period: OFF then ON DBSRandomized Discontinuation Period: ON then OFF DBS

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age21 Years - 70 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Men and women (non-pregnant) between ages 21 and 70;
DSM-5 diagnosis a current major depressive episode (MDE) for 10 years of less, recurrent or single episode with first episode after adulthood and did not start during childhood or adolescence, secondary to nonpsychotic unipolar major depressive disorder;

Study Design

Study Type

interventional

Phase

not applicable

Allocation

RANDOMIZED

Masking

NONE

Masking Details

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).

Purpose

DEVICE FEASIBILITY

Intervention Model

SEQUENTIAL

Model Details: 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.

Sponsor Type

OTHER

Responsible Party

SPONSOR INVESTIGATOR

PI Title

PROFESSOR & CHAIR

Tractography Guided Subcallosal Cingulate Deep Brain Stimulation for Treatment Resistant Depression

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (19)

Study Arms (2)

Randomized Discontinuation Period: OFF then ON DBS

Randomized Discontinuation Period: ON then OFF DBS

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (19)

Study Arms (2)

Randomized Discontinuation Period: OFF then ON DBS

Randomized Discontinuation Period: ON then OFF DBS

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations