Trial record 5 of 70 for:    deep brain stimulation depression

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

This study is currently recruiting participants.
Verified March 2014 by Mount Sinai School of Medicine
Sponsor:
Information provided by (Responsible Party):
Wayne Goodman, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT01798407
First received: February 21, 2013
Last updated: March 26, 2014
Last verified: March 2014
  Purpose

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


Condition Intervention Phase
Treatment Resistant Major Depressive Disorder
Device: Medtronic Activa Tremor Control System
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Clinical Pilot Study Examining Bilateral Inhibition of the Lateral Habenula as a Target for Deep Brain Stimulation in Intractable Depression

Resource links provided by NLM:


Further study details as provided by Mount Sinai School of Medicine:

Primary Outcome Measures:
  • Change in HDRS17 score from baseline to 6 months after the commencement of stimulation [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
    '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.


Secondary Outcome Measures:
  • Depression severity rating [ Time Frame: at 12 months ] [ Designated as safety issue: No ]
    including the Hamilton Rating Scale for Depression (HDRS17), the Quick Inventory of Depressive Symptomatology (QIDS-SR), the 30 item Inventory of Score comprised of Depressive Symptomatology (IDS-C, and the Montgomery-Asberg Depression Rating Scale (MADRS)], Clinical Global Impression of Severity and Improvement (CGI), the Quality of Life Assessment (SF-36), the Hamilton Anxiety Scale (HAM-A), Profile of Mood States (POMS)

  • Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: at 6 months ] [ Designated as safety issue: Yes ]
  • Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: at 12 months ] [ Designated as safety issue: Yes ]
  • Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: at 18 months ] [ Designated as safety issue: Yes ]
  • Young Mania Rating Scale (YMRS) [ Time Frame: at 6 months ] [ Designated as safety issue: Yes ]
  • Young Mania Rating Scale (YMRS) [ Time Frame: at 12 months ] [ Designated as safety issue: Yes ]
  • Young Mania Rating Scale (YMRS) [ Time Frame: at 18 months ] [ Designated as safety issue: Yes ]
  • Neuropsychological Battery [ Time Frame: at 6 months ] [ Designated as safety issue: Yes ]
  • Neuropsychological Battery [ Time Frame: at 12 months ] [ Designated as safety issue: Yes ]
  • Neuropsychological Battery [ Time Frame: at 18 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 6
Study Start Date: February 2013
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Medtronic Activa Tremor Control System
Deep brain stimulation is regularly used to treat Parkinson's Disease and movement disorders though recently there has been renewed interest in a psychosurgical approach using deep brain stimulation in treatment of severely treatment resistant depressive patients. (Goodwin and Insel, 2009)
Device: Medtronic Activa Tremor Control System
DBS system consists of the Activa RC 37612 System (Implantable Pulse Generator with Model 37085 Extensions, 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.
Other Names:
  • Deep Brain Stimulation System
  • DBS
  • Activa RC System
  • Medtronic DBS Lead
  • Activa Patient Programmer
  • N'Vision Clinical Programmer

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   21 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01798407

Contacts
Contact: Wayne K Goodman, MD (212) 659-8860 wayne.goodman@mssm.edu
Contact: Kyle Lapidus, MD, PhD (212) 659-8804 kyle.lapidus@mssm.edu

Locations
United States, New York
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
Contact: Wayne K Goodman, MD    212-659-8860    wayne.goodman@mssm.edu   
Contact: Kyle Lapidus, MD, PhD    (917) 969-3445    kyle.lapidus@mssm.edu   
Principal Investigator: Wayne K Goodman, MD         
Sub-Investigator: Fritz Henn, MD, PhD         
Sub-Investigator: Brian Kopell, MD         
Sub-Investigator: Kyle Lapidus, MD, PhD         
Sub-Investigator: Dan Iosifescu, MD         
Sub-Investigator: James Murrough, MD         
Sponsors and Collaborators
Wayne Goodman
Investigators
Principal Investigator: Wayne K Goodman, MD Mount Sinai School of Medicine
  More Information

No publications provided

Responsible Party: Wayne Goodman, Professor and Chair of Psychiatry, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT01798407     History of Changes
Other Study ID Numbers: GCO 12-1815, HSM#12-00467
Study First Received: February 21, 2013
Last Updated: March 26, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Mount Sinai School of Medicine:
Deep Brain Stimulation
Major Depressive Disorder
Depression
Lateral Habenula

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 17, 2014