NCT01898429

Brief Summary

In this pilot study, we propose to test whether high frequency stimulation of the subcallosal cingulate (SCC) is a safe and efficacious antidepressant treatment in five TRD patients, to compare the effects of left-sided vs. right-sided stimulation, and to investigate potential mechanisms of action of this intervention. Importantly, this study will be used to assess the need for and assist in planning a larger, more definitive trial of SCC DBS for TRD.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

July 9, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 12, 2013

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

September 12, 2018

Completed
Last Updated

July 25, 2019

Status Verified

July 1, 2019

Enrollment Period

3.4 years

First QC Date

July 9, 2013

Results QC Date

August 14, 2018

Last Update Submit

July 10, 2019

Conditions

Treatment Resistant DepressionDepressive Disorder, Treatment-ResistantDepression, Bipolar

Keywords

Treatment Resistant DepressionTreatment Refractory DepressionTreatment Resistant Bipolar DisorderTreatment Refractory Bipolar DisorderDeep brain stimulationDBS

Outcome Measures

Primary Outcomes (1)

  • Comparison of 12 Weeks of Left Unilateral DBS vs. 12 Weeks Right Unilateral DBS on Change in 17-item Hamilton Depression Rating Scale (HDRS-17)

    Baseline HDRS-17 is defined as the average of 4 weekly HDRS-17 in the 4 weeks leading up to surgery. Change in HDRS-17 after 12 weeks of left-sided stimulation (compared to baseline) will be compared to change in HDRS-17 after 12 weeks of right-sided stimulation (compared to baseline). The scale ranges from 0-48 with higher scored indicating more severe depression. A cutoff of 7 or below is considered remission from depression. A decrease of at least 50% from baseline is considered an antidepressant response.

    baseline, 12 weeks of phase 1, 12 weeks of phase 2 and 12 weeks of phase 3 (bilateral stimulation)

Study Arms (2)

Left-sided SCC DBS

ACTIVE COMPARATOR

Active Stimulation of the left-sided electrode

Device: SCC DBS

Right-sided SCC DBS

ACTIVE COMPARATOR

Active stimulation of the right-sided electrode

Device: SCC DBS

Interventions

SCC DBSDEVICE

Deep Brain Stimulator

Also known as: Libra(TM) Implantable Deep Brain Stimulation (DBS) System
Left-sided SCC DBSRight-sided SCC DBS

Eligibility Criteria

Age22 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
A partial list of eligibility criteria includes: * Age 18-70 years old * Ability to provide written informed consent * Current Major Depressive Episode (MDE), secondary to either Major Depressive Disorder or Bipolar Disorder (I, II or NOS) * A current depressive episode of at least 12 months duration * For patients with a bipolar disorder, the last hypomanic or manic episode must have been at least 2 years before study entry * A maximum Global Assessment of Functioning of 50 * Able to tolerate general anesthesia, DBS surgery and MRI scans * No significant cerebrovascular risk factors or a previous stroke, documented major head trauma or neurodegenerative disorder * No currently active clinically significant Axis I psychiatric diagnosis or a personality disorder likely to interfere with the study * No evidence of global cognitive impairment * Lives locally or willing to relocate to the area for up to One Year

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Treatment-ResistantBipolar Disorder

Interventions

Deep Brain StimulationDrug Delivery Systems

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersBipolar and Related Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsSurgical Procedures, OperativeDrug Therapy

Results Point of Contact

Title
Paul E. Holtzheimer, MD
Organization
Dartmouth Hitchcock Medical Center
Paul.E.Holtzheimer@hitchcock.org
603-650-4914

Study Officials

  • Paul E Holtzheimer, MD

    Dartmouth-Hitchcock Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Deputy Director for Research at the National Center for PTSD, Associate Professor for Dartmouth/Dartmouth Hitchcock.

Study Record Dates

First Submitted

July 9, 2013

First Posted

July 12, 2013

Study Start

July 1, 2013

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

July 25, 2019

Results First Posted

September 12, 2018

Record last verified: 2019-07

Locations

US(1)