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Arch Gen Psychiatry. 2012 Feb;69(2):150-8. doi: 10.1001/archgenpsychiatry.2011.1456. Epub 2012 Jan 2.

Subcallosal cingulate deep brain stimulation for treatment-resistant unipolar and bipolar depression.

Author information

  • 1Department of Psychiatry, Dartmouth Medical School, One Medical Center Dr, Lebanon, NH 03756, USA. paul.e.holtzheimer@dartmouth.edu

Abstract

CONTEXT:

Deep brain stimulation (DBS) may be an effective intervention for treatment-resistant depression (TRD), but available data are limited.

OBJECTIVE:

To assess the efficacy and safety of subcallosal cingulate DBS in patients with TRD with either major depressive disorder (MDD) or bipolar II disorder (BP).

DESIGN:

Open-label trial with a sham lead-in phase.

SETTING:

Academic medical center. Patients  Men and women aged 18 to 70 years with a moderate-to-severe major depressive episode after at least 4 adequate antidepressant treatments. Ten patients with MDD and 7 with BP were enrolled from a total of 323 patients screened. Intervention  Deep brain stimulation electrodes were implanted bilaterally in the subcallosal cingulate white matter. Patients received single-blind sham stimulation for 4 weeks followed by active stimulation for 24 weeks. Patients then entered a single-blind discontinuation phase; this phase was stopped after the first 3 patients because of ethical concerns. Patients were evaluated for up to 2 years after the onset of active stimulation.

MAIN OUTCOME MEASURES:

Change in depression severity and functioning over time, and response and remission rates after 24 weeks were the primary efficacy end points; secondary efficacy end points were 1 year and 2 years of active stimulation.

RESULTS:

A significant decrease in depression and increase in function were associated with chronic stimulation. Remission and response were seen in 3 patients (18%) and 7 (41%) after 24 weeks (n = 17), 5 (36%) and 5 (36%) after 1 year (n = 14), and 7 (58%) and 11 (92%) after 2 years (n = 12) of active stimulation. No patient achieving remission experienced a spontaneous relapse. Efficacy was similar for patients with MDD and those with BP. Chronic DBS was safe and well tolerated, and no hypomanic or manic episodes occurred. A modest sham stimulation effect was found, likely due to a decrease in depression after the surgical intervention but prior to entering the sham phase.

CONCLUSIONS:

The findings of this study support the long-term safety and antidepressant efficacy of subcallosal cingulate DBS for TRD and suggest equivalent safety and efficacy for TRD in patients with BP. Trial Registration  clinicaltrials.gov Identifier: NCT00367003.

PMID:
22213770
[PubMed - indexed for MEDLINE]
PMCID:
PMC4423545
Free PMC Article
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