Electrical Stimulation of the Internal Capsule for Intractable Depression

NCT01069952 | Completed Phase 2 DMC

• 2 other identifiers: G0103510201-001
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the safety and efficacy of deep brain stimulation in treating people with several and otherwise treatment-resistant depression.

Conditions

Depression

Keywords

Deep Brain Stimulation; Treatment Refractory; Neurosurgery; Implantable Neurostimulator (INS); Internal Capsule

Outcome Measures

Primary Outcomes (1)

• Hamilton Depression Rating Scale (HDRS)

  Administered at base line, every 1 to 5 days during the acute phase (2 months), monthly during the chronic phase, then every three months during the open continuation phase

Secondary Outcomes (1)

• Inventory for Depressive Symptoms, Self Report (IDS-SR)

  Administered at base line, every 1 to 5 days during the acute phase (2 months), monthly during the chronic phase, then every three months during the open continuation phase

Study Arms (1)

Active DBS

EXPERIMENTAL

Participants will receive deep brain stimulation.

Device: Deep Brain Stimulation System

Interventions

Deep Brain Stimulation System DEVICE

In DBS, thin wires are used to carry electric current to the parts of the brain involved in depression symptoms. These wires are implanted surgically and are attached to battery operated stimulators usually implanted in the chest. The study doctor will adjust the settings of the electrical stimulation to optimize treatment for each participant.

Also known as: Deep Brain Stimulation System from Medtronic, Inc., Implantable Neurostimulator (INS)

Active DBS

Eligibility Criteria

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

You may qualify if:

• Major depression, severe, unipolar type, diagnosed by Structural Clinical Interview for DSM-IV (SCID-IV), judged to be of disabling severity.
• item Hamilton Depression Rating Scale (HDRS) of at least 21.
• Global Assessment of Function (GAF) score of 45 or less.
• A recurrent (greater than or equal to 4 episodes) or chronic (episode duration greater than or equal to two 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 respond to:
• Adequate trials (greater than or equal to 6 weeks at the maximum recommended or tolerated dose) of primary antidepressants from at least 3 different classes and;
• Adequate trials (greater than or equal to 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 individual psychotherapy (greater than or equal to 20 sessions with an experienced psychotherapist)
• Age 18 to 65 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 non-affective 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 pre-surgical 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

• Butler Hospital: lead
• Medtronic: collaborator

Study Sites (1)

Butler Hospital

Providence, Rhode Island, 02906, United States

Location

Related Publications (2)

• Malone DA Jr, Dougherty DD, Rezai AR, Carpenter LL, Friehs GM, Eskandar EN, Rauch SL, Rasmussen SA, Machado AG, Kubu CS, Tyrka AR, Price LH, Stypulkowski PH, Giftakis JE, Rise MT, Malloy PF, Salloway SP, Greenberg BD. Deep brain stimulation of the ventral capsule/ventral striatum for treatment-resistant depression. Biol Psychiatry. 2009 Feb 15;65(4):267-75. doi: 10.1016/j.biopsych.2008.08.029. Epub 2008 Oct 8.

  PMID: 18842257 RESULT

• Carpenter LL, Friehs GM, Tyrka AR, Rasmussen S, Price LH, Greenberg BD. Vagus nerve stimulation and deep brain stimulation for treatment resistant depression. Med Health R I. 2006 Apr;89(4):137, 140-1.

  PMID: 16676910 RESULT

MeSH Terms

Conditions

Depression

Interventions

Implantable Neurostimulators

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Electrodes, Implanted; Electrodes; Electrical Equipment and Supplies; Equipment and Supplies; Prostheses and Implants

Study Officials

• Benjamin D Greenberg, MD, PhD

  Butler Hospital/Brown University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Outpatient Services, Associate Professor of Psychiatry

Study Record Dates

• First Submitted: February 16, 2010
• First Posted: February 17, 2010
• Study Start: December 1, 2002
• Primary Completion: May 1, 2004
• Last Updated: July 24, 2012

Record last verified: 2012-07

Locations

US (1)