Abstract
Background Multiple open-label trials of deep brain stimulation (DBS) for treatment-resistant depression (TRD), including those targeting the ventral capsule/ventral striatum target, have shown encouraging response rates. However, no randomized controlled trials of DBS for TRD have been published. Methods Thirty patients with TRD participated in a sham-controlled trial of DBS at the ventral capsule/ventral striatum target for TRD. Patients were randomized to active versus sham DBS treatment in a blinded fashion for 16 weeks, followed by an open-label continuation phase. The primary outcome measure was response, defined as a 50% or greater improvement on the Montgomery-Åsberg Depression Rating Scale from baseline. Results There was no significant difference in response rates between the active (3 of 15 subjects; 20%) and control (2 of 14 subjects; 14.3%) treatment arms and no significant difference between change in Montgomery-Åsberg Depression Rating Scale scores as a continuous measure upon completion of the 16-week controlled phase of the trial. The response rates at 12, 18, and 24 months during the open-label continuation phase were 20%, 26.7%, and 23.3%, respectively. Conclusion The results of this first randomized controlled study of DBS for the treatment of TRD did not demonstrate a significant difference in response rates between the active and control groups at the end of the 16-week controlled phase. However, a range of 20% to 26.7% of patients did achieve response at any time during the open-label continuation phase. Future studies, perhaps utilizing alternative study designs and stimulation parameters, are needed.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 240-248 |
| Number of pages | 9 |
| Journal | Biological Psychiatry |
| Volume | 78 |
| Issue number | 4 |
| DOIs | |
| State | Published - Aug 15 2015 |
| Externally published | Yes |
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Keywords
- DBS
- Deep brain stimulation
- Major depression
- TRD
- Treatment resistant depression
- Ventral capsule/ventral striatum
ASJC Scopus subject areas
- Biological Psychiatry
Cite this
A Randomized Sham-Controlled Trial of Deep Brain Stimulation of the Ventral Capsule/Ventral Striatum for Chronic Treatment-Resistant Depression. / Dougherty, Darin D.; Rezai, Ali R.; Carpenter, Linda L.; Howland, Robert H.; Bhati, Mahendra T.; O'Reardon, John P.; Eskandar, Emad N.; Baltuch, Gordon H.; Machado, Andre D.; Kondziolka, Douglas; Cusin, Cristina; Evans, Karleyton C.; Price, Lawrence H.; Jacobs, Karen; Pandya, Mayur; Denko, Timothey; Tyrka, Audrey R.; Brelje, Tim; Deckersbach, Thilo; Kubu, Cynthia; Malone, Donald A.
In: Biological Psychiatry, Vol. 78, No. 4, 15.08.2015, p. 240-248.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - A Randomized Sham-Controlled Trial of Deep Brain Stimulation of the Ventral Capsule/Ventral Striatum for Chronic Treatment-Resistant Depression
AU - Dougherty, Darin D.
AU - Rezai, Ali R.
AU - Carpenter, Linda L.
AU - Howland, Robert H.
AU - Bhati, Mahendra T.
AU - O'Reardon, John P.
AU - Eskandar, Emad N.
AU - Baltuch, Gordon H.
AU - Machado, Andre D.
AU - Kondziolka, Douglas
AU - Cusin, Cristina
AU - Evans, Karleyton C.
AU - Price, Lawrence H.
AU - Jacobs, Karen
AU - Pandya, Mayur
AU - Denko, Timothey
AU - Tyrka, Audrey R.
AU - Brelje, Tim
AU - Deckersbach, Thilo
AU - Kubu, Cynthia
AU - Malone, Donald A.
PY - 2015/8/15
Y1 - 2015/8/15
N2 - Background Multiple open-label trials of deep brain stimulation (DBS) for treatment-resistant depression (TRD), including those targeting the ventral capsule/ventral striatum target, have shown encouraging response rates. However, no randomized controlled trials of DBS for TRD have been published. Methods Thirty patients with TRD participated in a sham-controlled trial of DBS at the ventral capsule/ventral striatum target for TRD. Patients were randomized to active versus sham DBS treatment in a blinded fashion for 16 weeks, followed by an open-label continuation phase. The primary outcome measure was response, defined as a 50% or greater improvement on the Montgomery-Åsberg Depression Rating Scale from baseline. Results There was no significant difference in response rates between the active (3 of 15 subjects; 20%) and control (2 of 14 subjects; 14.3%) treatment arms and no significant difference between change in Montgomery-Åsberg Depression Rating Scale scores as a continuous measure upon completion of the 16-week controlled phase of the trial. The response rates at 12, 18, and 24 months during the open-label continuation phase were 20%, 26.7%, and 23.3%, respectively. Conclusion The results of this first randomized controlled study of DBS for the treatment of TRD did not demonstrate a significant difference in response rates between the active and control groups at the end of the 16-week controlled phase. However, a range of 20% to 26.7% of patients did achieve response at any time during the open-label continuation phase. Future studies, perhaps utilizing alternative study designs and stimulation parameters, are needed.
AB - Background Multiple open-label trials of deep brain stimulation (DBS) for treatment-resistant depression (TRD), including those targeting the ventral capsule/ventral striatum target, have shown encouraging response rates. However, no randomized controlled trials of DBS for TRD have been published. Methods Thirty patients with TRD participated in a sham-controlled trial of DBS at the ventral capsule/ventral striatum target for TRD. Patients were randomized to active versus sham DBS treatment in a blinded fashion for 16 weeks, followed by an open-label continuation phase. The primary outcome measure was response, defined as a 50% or greater improvement on the Montgomery-Åsberg Depression Rating Scale from baseline. Results There was no significant difference in response rates between the active (3 of 15 subjects; 20%) and control (2 of 14 subjects; 14.3%) treatment arms and no significant difference between change in Montgomery-Åsberg Depression Rating Scale scores as a continuous measure upon completion of the 16-week controlled phase of the trial. The response rates at 12, 18, and 24 months during the open-label continuation phase were 20%, 26.7%, and 23.3%, respectively. Conclusion The results of this first randomized controlled study of DBS for the treatment of TRD did not demonstrate a significant difference in response rates between the active and control groups at the end of the 16-week controlled phase. However, a range of 20% to 26.7% of patients did achieve response at any time during the open-label continuation phase. Future studies, perhaps utilizing alternative study designs and stimulation parameters, are needed.
KW - DBS
KW - Deep brain stimulation
KW - Major depression
KW - TRD
KW - Treatment resistant depression
KW - Ventral capsule/ventral striatum
UR - http://www.scopus.com/inward/record.url?scp=84937548452&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84937548452&partnerID=8YFLogxK
U2 - 10.1016/j.biopsych.2014.11.023
DO - 10.1016/j.biopsych.2014.11.023
M3 - Article
C2 - 25726497
AN - SCOPUS:84937548452
VL - 78
SP - 240
EP - 248
JO - Biological Psychiatry
JF - Biological Psychiatry
SN - 0006-3223
IS - 4
ER -