Subcallosal Cingulate Deep Brain Stimulation for Treatment-Resistant Unipolar and Bipolar Depression
Open accessAbstract
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.
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Responders to subcallosal cingulate cortex DBS shared a common map of stimulated fibers including bilateral forceps minor, bilateral cingulum bundles, dorsal and anterior midcingulate cortices, and medial branch of uncinated fasciculus.
“Responders shared a common map of stimulated fibers including bilateral forceps minor, bilateral cingulum bundles, dorsal and anterior midcingulate cortices, and medial branch of uncinated fasciculus.”
From Deep brain stimulation for depression. (2022) · cites this paper as [26]
In a retrospective analysis, clinical response to subcallosal cingulate cortex DBS was mediated by a direct impact on a combination of four fiber bundles passing through the SCC region.
“Using individual activation volumes and probabilistic tractography, they revealed that clinical response to SCC DBS was mediated by a direct impact on a combination of four fiber bundles passing through the SCC region.”
From Deep brain stimulation for depression. (2022) · cites this paper as [26]
Symptoms return in the order of weeks when SCC DBS is turned off, whereas symptoms return in the order of days when VC/VS DBS is turned off.
“It appears that symptoms return in the order of weeks when SCC DBS is turned off [26], whereas symptoms return on the order of days when VC/VS DBS is turned off [9].”
From Deep brain stimulation for depression. (2022) · cites this paper as [26]
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- Authors
- Holtzheimer, P. E.
- Affiliations
- Dartmouth College (US)
- Corresponding author
- Holtzheimer, Paul E.
- ORCID
- Holtzheimer, Paul E.
- Venue
- Archives of General Psychiatry
- Publisher
- American Medical Association (AMA)
- Published
- 2012-02-01
- Volume
- 69
- Issue
- 2
- Pages
- 150
- ISSN
- 0003-990X (ISSN-L)
- PMC
- PMC4423545
- OpenAlex
- W2132098276
- Cited by
- 608
- References
- 25
- Citations by year
- 2026: 21 · 2025: 19 · 2024: 27 · 2023: 27 · 2022: 23 · 2021: 34 · 2020: 27 · 2019: 44 · 2018: 62 · 2017: 37 · 2016: 42 · 2015: 65 · 2014: 68 · 2013: 68 · 2012: 41
- FWCI
- 50.00
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Archives of General Psychiatry (publishedVersion)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion)
- Funders
- Emory University
- Boston Scientific Corporation
- National Alliance for Research on Schizophrenia and Depression
- Bayer HealthCare
- National Institutes of Health
- St. Jude Medical
- National Institute of Mental Health (K23MH077869)
- Topics
- Health Sciences › Medicine › Neurology › Neurological disorders and treatments
- Health Sciences › Medicine › Pharmacology › Treatment of Major Depression
- Social Sciences › Psychology › Clinical Psychology › Obsessive-Compulsive Spectrum Disorders
- Keywords
- deep brain stimulation, subcallosal cingulate, treatment-resistant depression, major depressive disorder, bipolar II disorder, bipolar depression, antidepressant efficacy, long-term safety, sham stimulation
- MeSH terms
- Adult, Bipolar Disorder, Major Depressive Disorder, Female, Gyrus Cinguli, Humans, Male, Psychiatric Status Rating Scales, Time Factors, Single-Blind Method, Treatment Outcome, Deep Brain Stimulation
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