Deep Brain Stimulation (DBS) Therapy for Treatment Resistant Depression

NCT02046330 | Active Not Recruiting DMC

• 1 other identifier: HSC-MS-13-0004
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

We propose a clinical study of medial forebrain bundle DBS as a treatment in 20 patients with treatment refractory depression (TRD). Data from the University of Bonn indicates that surgical lesions of the medical forebrain bundle can produce therapeutic benefits in patients with depressive disorders, and suggest that DBS at the same site may also reduce symptomatology in these TRD patients (Schaepfer, 2013). Depression affects up to 10% of the US population and of those at least 10-15% do not benefit from therapies hence why we must explore new treatments. The Percept™ PC system manufactured by Medtronic Neurological will be used in this study. Study subjects will be between the ages of 22 and 70 years of age and suffer from TRD, have failed multiple treatment regimens, including ECT, and remain symptomatic. Those identified as TRD patients will then be enrolled in a clinical pilot study investigating DBS, targeting the MFB.

Conditions

Major Depressive Disorder; Treatment Resistant Depression

Keywords

Deep Brain Stimulation; Treatment Resistant Depression; Major Depressive Disorder; Depression; ECT; TNS

Outcome Measures

Primary Outcomes (1)

• Changes in patients MADRS scores

  We will assess individual patient response, measured by standardized patient and clinician ratings of depression severity, under blinded conditions. Prospective ratings using validated and reliable measures of symptoms, quality of life and safety will be employed. We will assess safety for all subjects by monitoring any adverse events.

  weekly (24 Months)

Secondary Outcomes (6)

• Accuracy of Electrode placement

  Post-operation (weekly for 24 months)

• Frequency and Charge of Stimulation

  Weekly (24 months total)

• Determine Feasibility of a Double Blind Study

  24 months

• Decrease in Neurocognitive scores on CSTC

  pre-operative, 12 month and 24 months post-operation

• Assess maintenance of treatment response (or remission) associated with chronic DBS:

  6, 12, and 24 months

Study Arms (1)

Deep Brain Stimulation

EXPERIMENTAL

Device implantation (Deep Brain Stimulation Model 3387 Model 3389)

Device: Deep Brain Stimulation Model 3387 Model 3389

Interventions

Deep Brain Stimulation Model 3387 Model 3389 DEVICE

Implantation of all devices will be performed at a single session. Lead implantation will take place under local anesthesia, with implanted pulse generator (IPG) implantation under general anesthesia. The stereotaxic frame will be fitted on the day of surgery, following standard stereotactic surgical procedure. The leads will be inserted so that the stimulation sites span superolateral median forebrain bundle.

Also known as: Medtronic Neuromodulation

Deep Brain Stimulation

Eligibility Criteria

• Age: 22 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Major Depression Disorder (MDD) diagnosed by Structured Clinical Interview for DSM-IV (SCID I/DSM-IV), judged to be of disabling severity.
• Age 22 - 70 years.
• item Hamilton Depression Rating Scale (HDRS) score of at least 21 on the first 17 items
• Global Assessment of Function (GAF) score of 45 or less.
• A recurrent (equal or \>4 episodes) or chronic (episode duration equal or higher \>2 years) course AND a minimum of 5 years since the onset of the first depressive episode. Major impairment in functioning or potentially severe medical outcomes (repeated hospitalizations, serious suicidal or other self-injurious behavior).
• Failure to respond to: 6.1. Adequate trials (equal or \>6 weeks at the maximum recommended or tolerated dose) of primary antidepressants from at least 3 different classes AND; 6.2. adequate trials ( equal\>4 weeks at the usually recommended or maximum tolerated dose) of augmentation/combination of a primary antidepressant using at least 2 different augmenting/combination agents (lithium, T3, stimulants, neuroleptics, anticonvulsants, buspirone, or a second primary antidepressant) AND; 6.3 An adequate trial of ECT (\>6 bilateral treatments), or inability to tolerate an adequate ECT trial, AND; 6.4 An adequate trial of individual psychotherapy (\>20 sessions with an experienced psychotherapist).
• Able to comply with the operational and administrative requirements of participation in the study.
• Able to give written informed consent
• On a stable drug regimen of psychotropic medication for at least 6 weeks at the time of entry into the study.
• Good general health. No changes in medication treatment during participation in study.

You may not qualify if:

• Current or past non-affective psychotic disorder, Bipolar Disorder, Schizophrenia, or Schizoaffective disorder. Patients who suffer from generalized anxiety disorder will be permitted to participate as long as MDD is the primary clinical diagnosis.
• Any current clinically significant neurological disorder, including dementia or medical illness affecting brain function.
• Any clinically significant abnormality on preoperative magnetic resonance imaging (MRI).
• Any previous surgery to destroy the region of the brain that will be the target of treatment.
• Any surgical contraindications to undergoing DBS, including labeled contraindications for DBS and/or inability to undergo presurgical MRI (cardiac pacemaker, implantable defibrillator or other implantable stimulator, pregnancy, metal in body, severe claustrophobia), infection, coagulopathy, inability to undergo an awake operation, significant cardiac or other medical risk factors for surgery.
• Refusal of an adequate trial of ECT.
• History of stimulation intolerance in any area of the body.
• Current or unstably remitted substance abuse or dependence. No alcohol and/or substance abuse or dependence in the past 6 months.
• Pregnancy and women of childbearing age not using effective contraception. Double-barrier method is required.
• History of severe personality disorder, where, based on the judgment of the investigators, the personality disorder will interfere with the patient's ability to complete the follow-up protocol, e.g. borderline personality disorder.
• Imminent risk of suicide
• Participation in another drug, device, or biologics trial within the preceding 30 days
• Presence of a condition requiring routine MRIs.
• Presence of a condition requiring diathermy.
• Subject is on anticoagulant medication.

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• Medtronic: collaborator

Study Sites (1)

UT Center of Excellence on Mood Disorders

Houston, Texas, 77054, United States

Location

Related Publications (1)

• Fenoy AJ, Schulz P, Selvaraj S, Burrows C, Spiker D, Cao B, Zunta-Soares G, Gajwani P, Quevedo J, Soares J. Deep brain stimulation of the medial forebrain bundle: Distinctive responses in resistant depression. J Affect Disord. 2016 Oct;203:143-151. doi: 10.1016/j.jad.2016.05.064. Epub 2016 Jun 3.

  PMID: 27288959 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major; Depressive Disorder, Treatment-Resistant; Depression

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Jair C Soares, MD, PhD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

• Joao Quevedo, MD, PhD

  The University of Texas Health Science Center, Houston

  STUDY DIRECTOR

• Giovana Zunta Soares, MD

  The University of Texas Health Science Center, Houston

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chair, Psy-Behavioral Sciences

Study Record Dates

• First Submitted: December 17, 2013
• First Posted: January 27, 2014
• Study Start: December 16, 2013
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: February 23, 2026

Record last verified: 2026-02

Locations

US (1)