Trial record 3 of 1137 for:    Open Studies | "Depression"

Deep Brain Stimulation (DBS) for Treatment-Resistant Depression (TRD)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Dartmouth-Hitchcock Medical Center
Sponsor:
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:
NCT01898429
First received: July 9, 2013
Last updated: May 19, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Treatment Resistant Depression
Depressive Disorder, Treatment-Resistant
Depression, Bipolar
Device: SCC DBS

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Deep Brain Stimulation for Treatment-Resistant Depression

Further study details as provided by Dartmouth-Hitchcock Medical Center:

Primary Outcome Measures:
  • Percent change in the Hamilton Depression Rating Scale (HDRS-17) from Baseline to Week 24 [ Time Frame: At 6 months of active stimulation ] [ Designated as safety issue: No ]
    Baseline HDRS-17 is defined as the average of 4 weekly HDRS-17 in the 4 weeks leading up to surgery. Patient response or remission criteria may be met prior to Week 24.


Estimated Enrollment: 5
Study Start Date: July 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Left-sided SCC DBS
Active Stimulation of the left-sided electrode
Device: SCC DBS
Deep Brain Stimulator
Other Name: Libra(TM) Implantable Deep Brain Stimulation (DBS) System
Active Comparator: Right-sided SCC DBS
Active stimulation of the right-sided electrode
Device: SCC DBS
Deep Brain Stimulator
Other Name: Libra(TM) Implantable Deep Brain Stimulation (DBS) System

Detailed Description:

The U.S. lifetime prevalence of major depressive disorder (MDD) is 17%. A number of treatments are available for depression including medications, psychotherapy and various somatic treatments. Unfortunately, up to two-thirds of patients remain symptomatic following first-line treatment and a third fail to achieve remission (defined as full resolution of depressive symptoms) after four established treatments; approximately 10%-20% of depressed patients may show virtually no improvement despite multiple, often aggressive treatments. Thus, a conservative estimate places the U.S. prevalence of treatment-resistant depression (TRD) at 1%-3%. TRD has a high risk of suicide, is a major cause of disability and is responsible for doubling of overall health care costs.

For patients with TRD there are limited evidence-based treatment options. Transcranial magnetic stimulation (TMS) may have efficacy for patients that have failed no more than one antidepressant medication 10-12, but response and remission rates are relatively low (under 30% and 20% respectively). Vagus nerve stimulation (VNS) may have efficacy in patients that have failed 4-6 antidepressant treatments but long-term response and remission rates are again low (about 20% and 10% respectively). Electroconvulsive therapy(ECT) can be effective in TRD patients with remission rates of 50%-60%. However, more than 70% of TRD patients will relapse within 6 months following a successful acute treatment course. For patients that have failed ECT, there are no evidence-based treatment options. Therefore, there is great need for novel treatment approaches for TRD.

Prior clinical trials have shown that SCC DBS has the potential to be a valuable treatment option for patients with TRD. Further developing this treatment will involve confirming its effectiveness and identifying ways to optimize its use. In this study we intend to test the safety and efficacy of chronic SCC DBS as a treatment for TRD and compare the safety and efficacy of left-sided versus right-sided stimulation using a double-blind, randomized, cross-over design.

  Eligibility

Ages Eligible for Study:   22 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01898429

Contacts
Contact: Ryan Trimble 603-650-4904 mood@dartmouth.edu
Contact: Paul E Holtzheimer, MD 603-650-4914 paul.e.holtzheimer@hitchcock.org

Locations
United States, New Hampshire
Dartmouth-Hitchcock Medical Center Recruiting
Lebanon, New Hampshire, United States, 03756
Principal Investigator: Paul E Holtzheimer, MD         
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
Investigators
Principal Investigator: Paul E Holtzheimer, MD Dartmouth-Hitchcock Medical Center
  More Information

No publications provided

Responsible Party: Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT01898429     History of Changes
Other Study ID Numbers: D12051, 23293
Study First Received: July 9, 2013
Last Updated: May 19, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Dartmouth-Hitchcock Medical Center:
Treatment Resistant Depression
Treatment Refractory Depression
Treatment Resistant Bipolar Disorder
Treatment Refractory Bipolar Disorder
Deep brain stimulation
DBS

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Treatment-Resistant
Bipolar Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Affective Disorders, Psychotic

ClinicalTrials.gov processed this record on September 16, 2014