A Pilot Study of Deep Brain Stimulation to the Lateral Habenulae in Treatment-Resistant Depression

Description

This research proposal will investigate the safety, tolerability, and efficacy of bilateral deep brain stimulation (DBS) to the lateral habenula for patients with highly treatment-resistant major depressive disorder (TRD). Six adult patients with TRD will be recruited for this single-site study at Mount Sinai Medical Center; patients will be chronically symptomatic with significant functional disability, and have demonstrated resistance to standard somatic and psychotherapeutic treatments. The primary outcome measure will be the change in the 17-item Hamilton Depression Rating Scale (HDRS17) 6 months after the commencement of stimulation.

Study Start Date

February 2013

Estimated Completion Date

June 2016

Interventions

  • Device: Medtronic Activa Tremor Control System

Specialties

  • Psychiatry : Anxiety,Mood Disorders

MeSH Terms

  • Medtronic Activa Tremor Control System
  • Treatment Resistant Major Depressive Disorder

Study ID

Mount Sinai School of Medicine -- GCO 12-1815

Status

Unknown

Trial ID

NCT01798407

Study Type

Interventional

Trial Phase

Phase 1

Enrollment Quota

6

Sponsor

Mount Sinai School of Medicine

Inclusion Criteria

  • Men and women (non-pregnant) between ages 21 and 70
  • DSM-IV diagnosis ( assessed by Structured Clinical Interview for DSM-IV Axis I disorders, SCID-I) of unipolar major depressive disorder (MDD), non-psychotic, single or recurrent episode, with first episode before age 45
  • Chronic illness with current episode ? 24 months duration and/or recurrent illness with at least a total of 4 lifetime episodes (including current episode ? 12 months)
  • Treatment Resistance (defined by criteria on the Antidepressant Treatment History Form): Failure (i.e., persistence of the major depressive episode) to respond to a minimum of three adequate depression treatments from at least two different treatment categories (e.g., SSRI's, TCA's, other antidepressants, lithium-addition, irreversible MAO-inhibitor, antidepressant augmentation with an atypical antipsychotic medication)
  • Previous trial of ECT (lifetime)
  • Symptom severity: HDRS17 ? 21
  • The Hamilton Depression score must remain greater than 20 on two separate assessments (at initial screening and 1 week before surgery), over a 1-month period
  • Normal brain MRI within 3 months of surgery
  • Stable antidepressant medical regimen for the month preceding surgery
  • Modified Mini-Mental State Examination (MMSE) score ? 27
  • Normal thyroid stimulating hormone (TSH) level within 12 months of study entry
  • Other medical conditions must be stable for at least 1 year
  • Anticipates a stable psychotropic medication regiment in the next 24 months
  • Patient must be able to identify a family member, physician, or friend who will participate in the Treatment Contract
  • Able and willing to give informed consent

Exclusion Criteria

  • Axis I disorders (assessed by Structured Clinical Interview for DSM-IV Axis I disorders, SCID-I): Bipolar I or II disorder
  • Bipolar NOS any lifetime history of psychotic disorder (e.g., schizophrenia, schizoaffective disorder, or non-affective psychosis) presence of primary or serious (requiring additional treatment) disorders: comorbid obsessive compulsive disorder, post-traumatic stress disorder, panic disorder, bulimia or anorexia, in the last year
  • Cluster A or B personality disorder
  • Alcohol or substance abuse/dependence within 6 months, excluding nicotine
  • Current substantial suicidal risk as defined by a plan or clear immediate intent for self-harm, or had a serious suicide attempt within the last year
  • Neurological disease that impairs motor, sensory or cognitive function or that requires intermittent or chronic medication (e.g., Parkinson's disease, MS, stroke)
  • Any history of seizure disorder or hemorrhagic stroke
  • Any medical contraindication to surgery, including infection or coagulopathy
  • Participation in another drug, device, or biological trial within 30 days
  • Current implanted stimulation devices including cardiac pacemakers, defibrillators, and neurostimulators including spinal cord stimulators, deep brain stimulators, and vagus nerve stimulators
  • Does not have adequate family/friend support as determined by psychological screening and/or interview
  • Abnormal brain MRI
  • Unable to maintain a stable psychotropic medication regiment in the next 24 months
  • Pregnant or has plans to become pregnant in the next 24 months

Gender

Both

Ages

21 Years to 65 Years

Accepts Healthy Volunteers

No

Study Locations and Contact Information (1)

Study Location Distance Name Phone Email
Icahn School of Medicine at Mount Sinai - New York, New York 46.8 miles Wayne K Goodman MD 212-659-8860 wayne.goodman@mssm.edu

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