Feasibility, Safety and Efficacy of Deep Brain Stimulation for Depression

Completed · Early Phase 1

Conditions studied: Depression

In brief

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.

Key facts

Study ID

NCT00555698

Run by

Ali Rezai, MD

People needed

8

Starts

2004-01-01

Expected to finish

2011-02-01

Last updated by the study team

2017-03-28

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

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
• 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.

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).

Where it is running

• Cleveland Clinic Foundation — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.