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Feasibility, Safety and Efficacy of Deep Brain Stimulation for Depression

Primary Purpose

Depression

Status

Completed

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

Deep Brain Stimulations for Depression

About this trial

This is an interventional treatment trial for Depression focused on measuring DBS, Depression

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Major depression, severe, unipolar type, diagnosed by Structured Clinical Interview for DSM-IV (SCID-IV), judged to be of disabling severity
24-item Hamilton Depression Rating Scale (HDRS) score of at least 21
Global Assessment of Function (GAF) score of 45 or less.
A recurrent (>4 episodes) or chronic (episode duration >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:
- adequate trials (>6 weeks at the maximum recommended or tolerated dose) of primary antidepressants from at least 3 different classes and;
- adequate trials (>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;
- an adequate trial of ECT (>6 bilateral treatments) and;
- an adequate trial of individual psychotherapy (>20 sessions with an experienced psychotherapist).
Age 18 - 55 years.
Able to comply with the operational and administrative requirements of participation in the study.
Able to give written informed consent.
Either drug-free or on a stable drug regimen for at least 6 weeks at the time of entry into the study.
Good general health.

Exclusion Criteria:

Current or past nonaffective psychotic disorder.
Any current clinically significant neurological disorder or medical illness affecting brain function, other than motor tics or Gilles de la Tourette syndrome.
Any clinically significant abnormality on preoperative magnetic resonance imaging (MRI)
Any surgical contraindications to undergoing DBS, including labeled contraindications for DBS and/or inability to undergo presurgical MRI (cardiac pacemaker, pregnancy, metal in body, severe claustrophobia), infection, coagulopathy, inability to undergo an awake operation, significant cardiac or other medical risk factors for surgery.
Current or unstably remitted substance abuse.
Pregnancy and women of childbearing age not using effective contraception.
History of severe personality disorder.
Imminent risk of suicide (based on the judgment of the investigators).
Not able to comply with the operational and administrative requirements of participation in the study (based on the judgment of the investigators).

Sites / Locations

Cleveland Clinic Foundation

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

DBS

Arm Description

DBS

Outcomes

Primary Outcome Measures

Montgomery-Asberg Depression Rating Scale (MADRS), Hamilton Depression Rating Scale (HDRS)

Secondary Outcome Measures

Inventory for Depressive Symptoms, Self-report (IDS-SR), Clinical Global Impressions (CGI), Patient Global Impressions (PGI), Global Assessment of Functioning (GAF), Social and Occupational Function Assessment Scale (SOFAS), Quality of LIfe Enjoyment and

Full Information

NCT ID

NCT00555698

First Posted

November 7, 2007

Last Updated

March 24, 2017

Sponsor

Ali Rezai, MD

Collaborators

Medtronic, The Cleveland Clinic

1. Study Identification

Unique Protocol Identification Number

NCT00555698

Brief Title

Feasibility, Safety and Efficacy of Deep Brain Stimulation for Depression

Official Title

Feasibility, Safety and Efficacy of Deep Brain Stimulation of the Internal Capsule for Severe and Medically Refractory Major Depression

Study Type

Interventional

2. Study Status

Record Verification Date

March 2017

Overall Recruitment Status

Completed

Study Start Date

January 2004 (undefined)

Primary Completion Date

February 2011 (Actual)

Study Completion Date

February 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Ali Rezai, MD

Collaborators

Medtronic, The Cleveland Clinic

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this investigation is to obtain a preliminary indication of the feasibility, safety and efficacy of capsular deep brain stimulation (DBS) as a treatment for intractable depression. Also, to to learn about a new treatment for severe depression that has not improved enough despite long-term treatment with medications and behavior therapy. The new treatment is called deep brain stimulation, or DBS. In DBS, thin wires are used to carry electric current to parts of the brain that are thought to be involved in producing depression symptoms. Two wires are implanted surgically, and attached to battery packs implanted under the skin of the new chest below your collar bone.

Detailed Description

This protocol proposes a pilot/feasibility clinical study of therapeutic benefits of ventral capsule/ventral striatum deep brain stimulation (DBS) as a treatment in ten patients with intractable major depression (MD). Conservative estimates place MD's prevalence at 2.6% to 5.5% in men and 6.0% to 11.8% in women. Most conservative studies estimate a 20% complete refractoriness to medical and psychotherapeutic regimens. Given the prevalence of major depression in the general population, over 3.5 million Americans would be expected to manifest refractory illness if all those with depression received treatment. Study subjects will have MD of disabling severity, intractable to prolonged treatment attempts with conventional medication and pschotherapies. They must also have had electroconvulsive therapy. These refractory patients would be candidates for a destructive/lesioning brain surgery such as a radiofrequency cingulotomy. These MD patients are analogous to medically intractable Parkinson's disease and tremor patients who until recently underwent similar destructive surgeries such as a pallidotomy or thalamotomy. The use of DBS technology with its inherent advantage of being fully reversible and adjustable has become standard of care for these disabled patients. Studies have demonstrated improved safety and efficacy of DBS over lesioning. Recently, DBS technology has been employed in the lesioning target of the anterior limb of the internal capsule for OCD. These preliminary studies in Europe and now the US, are demonstrating improved outcomes for refractory OCD patients with regard to their OC symptoms as well as depressed mood. This amelioration of mood provides the basis on which anterior internal capsule DBS may help major depression patients. Based on this rationale, we believe that DBS is a viable therapeutic surgical option in this group of severely ill MD patients. The standard DBS stereotactic surgical techniques employed by the CCF team in hundreds of movement disorder patients will be used. The DBS electrodes will be implanted bilaterally in the anterior limb of the internal capsule and connected subcutaneously to subclavicular programmable pulse generators.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Depression

Keywords

DBS, Depression

7. Study Design

Primary Purpose

Treatment

Study Phase

Early Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

8 (Actual)

8. Arms, Groups, and Interventions

Arm Title

DBS

Arm Type

Experimental

Arm Description

DBS

Intervention Type

Device

Intervention Name(s)

Deep Brain Stimulations for Depression

Intervention Description

Deep Brain Stimulations for Depression

Primary Outcome Measure Information:

Title

Montgomery-Asberg Depression Rating Scale (MADRS), Hamilton Depression Rating Scale (HDRS)

Time Frame

These scales are administered on each postoperative clinic visit. Visits occur monthly, except during the open continuation phase, when they occur every three months.

Secondary Outcome Measure Information:

Title

Time Frame

These measures will be obtained at baseline, at the end of the initial chronic phase (typically after three months of chronic stimultion), at the end of the open continuation phase (at two years into the study).

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Major depression, severe, unipolar type, diagnosed by Structured Clinical Interview for DSM-IV (SCID-IV), judged to be of disabling severity 24-item Hamilton Depression Rating Scale (HDRS) score of at least 21 Global Assessment of Function (GAF) score of 45 or less. A recurrent (>4 episodes) or chronic (episode duration >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: adequate trials (>6 weeks at the maximum recommended or tolerated dose) of primary antidepressants from at least 3 different classes and; adequate trials (>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; an adequate trial of ECT (>6 bilateral treatments) and; an adequate trial of individual psychotherapy (>20 sessions with an experienced psychotherapist). Age 18 - 55 years. Able to comply with the operational and administrative requirements of participation in the study. Able to give written informed consent. Either drug-free or on a stable drug regimen for at least 6 weeks at the time of entry into the study. Good general health. Exclusion Criteria: Current or past nonaffective psychotic disorder. Any current clinically significant neurological disorder or medical illness affecting brain function, other than motor tics or Gilles de la Tourette syndrome. Any clinically significant abnormality on preoperative magnetic resonance imaging (MRI) Any surgical contraindications to undergoing DBS, including labeled contraindications for DBS and/or inability to undergo presurgical MRI (cardiac pacemaker, pregnancy, metal in body, severe claustrophobia), infection, coagulopathy, inability to undergo an awake operation, significant cardiac or other medical risk factors for surgery. Current or unstably remitted substance abuse. Pregnancy and women of childbearing age not using effective contraception. History of severe personality disorder. Imminent risk of suicide (based on the judgment of the investigators). Not able to comply with the operational and administrative requirements of participation in the study (based on the judgment of the investigators).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ali Rezai, MD

Organizational Affiliation

The Cleveland Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cleveland Clinic Foundation

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44195

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

16855529

Citation

Greenberg BD, Malone DA, Friehs GM, Rezai AR, Kubu CS, Malloy PF, Salloway SP, Okun MS, Goodman WK, Rasmussen SA. Three-year outcomes in deep brain stimulation for highly resistant obsessive-compulsive disorder. Neuropsychopharmacology. 2006 Nov;31(11):2384-93. doi: 10.1038/sj.npp.1301165. Epub 2006 Jul 19. Erratum In: Neuropsychopharmacology. 2006 Nov;31(11):2394.

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Feasibility, Safety and Efficacy of Deep Brain Stimulation for Depression

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