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RECLAIM Deep Brain Stimulation (DBS) Clinical Trial for Treatment-Resistant Depression
| Organizations
| Butler |
| Principal Investigator
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Linda Carpenter MD
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| Eligibility Criteria
| Patients must be referred for DBS by their psychiatrist.
DBS will be evaluated as an adjunct therapy to ongoing pharmacotherapy in adult patients with Unipolar Major Depression who (1) are in an episode of depression for at least 2 years, and (2) have had four or more adequate antidepressant treatment trials.
Appropriate candidates will take part in a thorough screening process, which will determine ultimate eligibility for the study. |
| Date Study Started
| 07/28/2009 |
| Date Study Ends
| 08/01/2014 |
| Recruitment Status
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Open
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| Contact Information
| Psychiatrists can fax or send a referral letter to Linda L. Carpenter, MD if they would like one of their patients to be considered for the DBS clinical trial.
Fax: (401) 455-6534
Mailing Address:
Linda L. Carpenter, MD
Mood Disorders Research Program
Butler Hospital
345 Blackstone Blvd.
Providence, RI 02906
Patients and care providers who would like to learn more about the study can call Sarah Marsella (401) 455 6537. |
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| The purpose of the study is to learn more about the safety and effectiveness of DBS therapy for adults with chronic severe treatment-resistant major depression. The device uses thin wires to deliver electric current to a very specific target in the brain. The wires are attached to pulse generators that are implanted in the chest, (similar to those used for cardiac pacemakers) and programmed via telemetric wands. The stimulation target for this study is a small group of nerve fibers in the brain called the ventral capsule/ventral striatum (VC/VS) which connect to areas of the brain believed to be involved in the symptoms of major depression. The study is composed of multiple phases, with participants being followed over a period of 5 years. |
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