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Outcome Measures

Primary Outcomes (1)

Change in HDRS^17 score from baseline to 6 months after the commencement of stimulation
'Response' is categorically defined as a ≥ 50% reduction in the HDRS17 score relative to the baseline assessment. 'Remission' is defined as an absolute HDRS17 score \< 8. Study success criteria will be defined as ≥ 3 of the 6 patients meeting the individual subject success criteria of response or remission by HDRS17 score at the 6 month time point.
baseline, Month 6, Month 12 and 18 months

Secondary Outcomes (10)

MADRS (Montgomery and Asberg Depression Rating Scale)
baseline, Month 6, Month 12 and 18 months
Clinical Global Impression of Severity (CGI-S)
baseline, Month 6, Month 12 and 18 months
Clinical Global Impression of Improvement (CGI-I)
baseline, Month 6, Month 12 and 18 months
Young Mania Rating Scale (YMRS)
baseline, Month 6, Month 12 and 18 months
Columbia Suicide Severity Rating Scale (C-SSRS)
baseline, Month 6, Month 12 and 18 months
+5 more secondary outcomes

Study Arms (2)

Activa Tremor Control Sys (DBS Implant)

EXPERIMENTAL

all subjects will receive bilateral surgical implantation of DBS system. Those who respond at 12 months will enter a randomized, staggered withdrawal phase.

Device: Activa Tremor Control Sys (DBS Implant)

Randomized, staggered withdrawal phase

EXPERIMENTAL

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.

Other: Randomized, staggered withdrawal phase

Interventions

Activa Tremor Control Sys (DBS Implant)Device

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.

Also known as: Deep Brain Stimulation System, DBS, Activa RC System

Activa Tremor Control Sys (DBS Implant)

Randomized, staggered withdrawal phaseOther

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 (assessed by Structured Clinical Interview for DSM-5, SCID-5) of a current major depressive episode (MDE), recurrent or single episode with first episode before age 45, secondary to either nonpsychotic unipolar major depressive disorder (MDD)or bipolar disorder (BD) I;

Related Publications (29)

Bewernick BH, Hurlemann R, Matusch A, Kayser S, Grubert C, Hadrysiewicz B, Axmacher N, Lemke M, Cooper-Mahkorn D, Cohen MX, Brockmann H, Lenartz D, Sturm V, Schlaepfer TE. Nucleus accumbens deep brain stimulation decreases ratings of depression and anxiety in treatment-resistant depression. Biol Psychiatry. 2010 Jan 15;67(2):110-6. doi: 10.1016/j.biopsych.2009.09.013.

PMID: 19914605BACKGROUND

Kennedy SH, Giacobbe P, Rizvi SJ, Placenza FM, Nishikawa Y, Mayberg HS, Lozano AM. Deep brain stimulation for treatment-resistant depression: follow-up after 3 to 6 years. Am J Psychiatry. 2011 May;168(5):502-10. doi: 10.1176/appi.ajp.2010.10081187. Epub 2011 Feb 1.

PMID: 21285143BACKGROUND

MeSH Terms

Conditions

Depressive Disorder, MajorDepressionDepressive Disorder, Treatment-Resistant

Interventions

Deep Brain StimulationRandom Allocation

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsSurgical Procedures, Operative

Study Design

Study Type

interventional

Phase

not applicable

Allocation

NON RANDOMIZED

Masking

QUADRUPLE

Who Masked

PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR

Masking Details

During staggered withdrawal phase, 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 every 2 weeks 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.

Purpose

TREATMENT

Intervention Model

SEQUENTIAL

Model Details: all subjects will receive bilateral surgical implantation of DBS system. Those who respond at 12 months will enter a randomized, staggered withdrawal phase. See masking description below.

Sponsor Type

OTHER

Responsible Party

SPONSOR INVESTIGATOR

PI Title

Principal Investigator; Chairman

DBS of the Lateral Habenula in Treatment-Resistant Depression

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (10)

Study Arms (2)

Activa Tremor Control Sys (DBS Implant)

Randomized, staggered withdrawal phase

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (29)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

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

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (10)

Study Arms (2)

Activa Tremor Control Sys (DBS Implant)

Randomized, staggered withdrawal phase

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (29)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations