Electrical Stimulation of the Internal Capsule for Intractable Depression

Completed · Phase 2

Conditions studied: Depression

In brief

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

Key facts

Study ID

NCT01069952

Run by

Butler Hospital

People needed

5

Starts

2002-12-01

Last updated by the study team

2012-07-24

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

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.
• 24-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).

Where it is running

• Butler Hospital — Providence, Rhode Island, United States

Full record on ClinicalTrials.gov

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