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Trial record 5 of 105 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. (see Contacts and Locations)
Verified October 2015 by Icahn School of Medicine at Mount Sinai
Information provided by (Responsible Party):
Wayne Goodman, Icahn School of Medicine at Mount Sinai Identifier:
First received: February 21, 2013
Last updated: October 13, 2015
Last verified: October 2015
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 depression (TRD) secondary to either nonpsychotic unipolar major depressive disorder (MDD), or bipolar disorder (BD) I. 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: Open Label
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 Icahn School of Medicine at Mount Sinai:

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: June 2016 (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


Ages Eligible for Study:   21 Years to 70 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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 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;
  • Chronic illness with current MDE ≥ 24 months duration and/or recurrent illness with at least a total of 4 lifetime episodes (including current episode ≥ 12 months);
  • For patients with a bipolar disorder: the last manic or hypomanic episode must have been ≥ 24 months before study enrollment and patients must be maintained on a mood stabilizer (e.g. lithium or another mood stabilizer approved for bipolar disorder).
  • 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); also, if diagnosed as bipolar, failure to respond to (or inability to tolerate) a minimum of three treatments approved for bipolar disorder, including lithium and at least one medication FDA-approved for bipolar depression (e.g., olanzapine/fluoxetine combination, quetiapine, lurasidone).
  • 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 regimen 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): 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 regimen in the next 24 months
  • Pregnant or has plans to become pregnant in the next 24 months.
  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 identifier: NCT01798407

Contact: Wayne K Goodman, MD (212) 659-8860
Contact: David Rosenthal (212) 659-8803

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   
Contact: David Rosenthal    (212) 659-8803   
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
Principal Investigator: Wayne K Goodman, MD Icahn School of Medicine at Mount Sinai
  More Information

Responsible Party: Wayne Goodman, Professor and Chair of Psychiatry, Icahn School of Medicine at Mount Sinai Identifier: NCT01798407     History of Changes
Other Study ID Numbers: GCO 12-1815  HSM#12-00467 
Study First Received: February 21, 2013
Last Updated: October 13, 2015
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Depressive Disorder
Depressive Disorder, Major
Depressive Disorder, Treatment-Resistant
Behavioral Symptoms
Mood Disorders
Mental Disorders processed this record on September 29, 2016