2024-12-18 ワシントン大学セントルイス校
ワシントン大学セントルイス校(WashU)の研究者たちは、治療抵抗性の重度うつ病患者に対する迷走神経刺激療法(VNS)の効果を検証する全国規模の臨床試験「RECOVER」を実施しました。試験では、全員に左側の迷走神経を刺激するデバイスを埋め込みましたが、半数のデバイスは作動させず、効果を比較しました。主要な評価ツールでは有意差が見られなかったものの、他の多くの評価指標では、デバイスが作動しているグループで抑うつ症状、生活の質、日常生活の機能において有意な改善が確認されました。具体的には、作動グループの67.6%が症状の改善を示し、43.3%が寛解に達しました。一方、非作動グループでは、改善は40.9%、寛解は25.7%にとどまりました。
◆この研究結果は、2024年12月18日に『Brain Stimulation』誌に掲載されました。これにより、治療抵抗性うつ病患者への新たな治療オプションが広がる可能性があります。
<関連情報>
- https://source.washu.edu/2024/12/vagus-nerve-stimulation-relieves-severe-depression/
- https://medicine.washu.edu/news/vagus-nerve-stimulation-relieves-severe-depression/
- https://www.brainstimjrnl.com/article/S1935-861X(24)01390-1/fulltext
- https://www.brainstimjrnl.com/article/S1935-861X(24)01382-2/fulltext
治療抵抗性うつ病における迷走神経刺激: 1年間の無作為化偽薬対照試験 Vagus nerve stimulation in treatment-resistant depression: A one-year, randomized, sham-controlled trial
Charles R. Conway∙ Scott T. Aaronson ∙ Harold A. Sackeim∙ … ∙ Quyen Tran ∙ Laura Yates ∙ A. John Rush…
Brain Stimulation Published:December 18, 2024
DOI:https://doi.org/10.1016/j.brs.2024.12.1191
Highlights (3–5 bullets; maximum 85 characters each)
•VNS has antidepressant benefits in marked treatment-resistant depression.
•Percent time in MADRS response did not distinguish active from sham VNS.
•Patients, offsite raters, and clinicians found VNS reduced depressive symptoms in other measures.
•Large benefit for remission, response, and partial response by onsite clinicians (CGI-I).
•Partial antidepressant response was most sensitive to between-group differences.
Abstract
Background
Few treatments are available for individuals with marked treatment-resistant depression (TRD).
Objective
Evaluate the safety and effectiveness of FDA-approved adjunctive vagus nerve stimulation (VNS) in patients with marked TRD.
Methods
This 12-month, multicenter, double-blind, sham-controlled trial included 493 adults with marked treatment-resistant major depression who were randomized to active or no-stimulation sham VNS for 12 months. The primary outcome was percent time in response across months 3–12, with response defined as a ≥50 % change from baseline on the Montgomery-Åsberg Depression Rating Scale (MADRS). Several secondary endpoints were evaluated.
Results
Overall, 88.4 % of participants completed the trial. Percent time in MADRS response did not distinguish active from sham VNS. However, ratings from on-site clinicians (Clinical Global Inventory–Impression [CGI-I]), patients (Quick Inventory of Depressive Symptomology–Self Report [QIDS-SR]), and offsite masked raters (Quick Inventory of Depressive Symptomology–Clinician [QIDS-C]) revealed antidepressant benefits significantly favoring active VNS. Active VNS demonstrated significantly more percent time in response on the CGI-I (P = 0.004) and QIDS-SR (P = 0.049), and significantly more percent time in partial response (PR; symptom improvement ≥30 %) on the CGI-I (P < 0.001) and QIDS-C (P = 0.006) versus sham VNS. Active VNS exceeded sham VNS in rate of dyspnea (P = 0.035), a known side effect of VNS. No new adverse events were identified.
Conclusions
Percent time in MADRS response did not distinguish the treatment groups, but on multiple instruments time in response and PR showed a positive treatment effect. VNS was found safe and effective in participants with marked TRD.
著明な治療抵抗性の大うつ病における迷走神経刺激が日常生活機能とQOLに及ぼす影響: 1年間の無作為化偽薬対照試験の結果 Effects of vagus nerve stimulation on daily function and quality of life in markedly treatment-resistant major depression: Findings from a one-year, randomized, sham-controlled trial
A. John Rush∙ Charles R. Conway∙ Scott T. Aaronson∙ … ∙ Jeffrey Way∙ Bryan Olin∙ Harold A. Sackeim…
Brain Stimulation Published:December 18, 2024
DOI:https://doi.org/10.1016/j.brs.2024.12.1187
Highlights
•Adjunctive vagus nerve stimulation improves quality of life and daily function.
•VNS therapy showed consistent improvements in quality of life over 12 months.
•Quality of life and daily function are essential indicators of treatment benefit.
•Mini-Q-LES-Q was more sensitive than the Q-LES-Q in detecting treatment effects.
Abstract
Background
Depression treatments aim to minimize symptom burden and optimize quality of life (QoL) and psychosocial function.
Objective
Compare the effects of adjunctive versus sham vagus nerve stimulation (VNS) on QoL and function in markedly treatment-resistant depression (TRD).
Methods
In this multicenter, double-blind, sham-controlled trial, 493 adults with TRD and ≥4 adequate but unsuccessful antidepressant treatment trials (current episode) were randomized to active (n = 249) or sham (n = 244) VNS (plus treatment as usual) over a 12-month observation period. Quarterly outcomes included QoL with the Q-LES-Q, Mini-Q-LES-Q, and EQ-5D-5L, and function with the WHODAS 2.0 and Work Productivity and Activity Impairment Questionnaire (WPAI) item 6. Differences between treatment groups in change in scores from baseline and percentage of time with a meaningful response in Q-LES-Q, Mini-Q-LES-Q, and WPAI item 6 scores were analyzed.
Results
Active VNS was superior to sham in mean change in scores from baseline in the Mini-Q-LES-Q (P = 0.050) and WPAI item 6 (health condition’s effect on regular activities [P = 0.050]) used as continuous variables, with a similar trend for Q-LES-Q (P = 0.061). Active VNS was superior to sham in time spent in clinically meaningful benefit (categorical analyses) using the Q-LES-Q (P = 0.029), Mini-Q-LES-Q (P = 0.011), and WPAI item 6 (P = 0.039). The WHODAS 2.0 (P = 0.304) and EQ-5D visual analog scale (P = 0.125) failed to reveal between-group differences.
Conclusion
Active VNS was superior to sham VNS in improving QoL and psychosocial function in patients with TRD. VNS has a broader therapeutic impact than symptom improvement alone in patients with marked psychosocial impairment.
