Feasibility, Safety and Efficacy of Deep Brain Stimulation for Depression

NCT00555698 | Completed Early Phase 1 DMC

• 1 other identifier: 6577
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Keywords

DBS; Depression

Outcome Measures

Primary Outcomes (1)

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

  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 Outcomes (1)

• 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

  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).

Study Arms (1)

DBS

EXPERIMENTAL

DBS

Device: Deep Brain Stimulations for Depression

Interventions

Deep Brain Stimulations for Depression DEVICE

Deep Brain Stimulations for Depression

DBS

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Major depression, severe, unipolar type, diagnosed by Structured Clinical Interview for DSM-IV (SCID-IV), judged to be of disabling severity
• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Ali Rezai, MD: lead
• Medtronic: collaborator
• The Cleveland Clinic: collaborator

Study Sites (1)

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Related Publications (1)

• 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.

  PMID: 16855529 BACKGROUND

MeSH Terms

Conditions

Depression

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Surgical Procedures, Operative

Study Officials

• Ali Rezai, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 7, 2007
• First Posted: November 9, 2007
• Study Start: January 1, 2004
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: March 28, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)