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A Randomized Sham-Controlled Trial of Deep Brain Stimulation of the Ventral Capsule/Ventral Striatum for Chronic Treatment-Resistant Depression

Published:December 12, 2014DOI:https://doi.org/10.1016/j.biopsych.2014.11.023

      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.

      Keywords

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      Linked Article

      • Deep Brain Stimulation for Major Depression—Steps on a Long and Winding Road
        Biological PsychiatryVol. 78Issue 4
        • Preview
          Most patients with psychiatric disorders respond to combinations of psychotherapy and psychopharmacotherapy; however, some patients experience little, if any, benefit even after many years of treatment (1). Over the past decade, different modalities of targeted neuromodulation—among them most prominently deep brain stimulation (DBS)—are being actively researched as putative approaches to very treatment-resistant forms of those disorders. The fact that patients included in all DBS studies so far had been treated unsuccessfully for many years with conventional treatment methods renders these findings remarkable.
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