The time course, extent, and durability of improvement in depressive symptoms, daily function, and quality of life with three years of vagus nerve stimulation in markedly treatment-resistant major depression: A RECOVER study report
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Background
In markedly treatment-resistant depression, the RECOVER trial compared the time course, extent, and durability of benefits in groups randomized to three years of active VNS (Early-Active) or one year of sham VNS followed by two years of active VNS (Delayed-Active).
Methods
For 436 participants completing month-12 (M12) assessments (Early-Active N=221; Delayed-Active N=215), longitudinal mixed-effects models characterized trajectories of benefit over 36 months in categorical outcomes pooled across blinded depressive symptom and global improvement measures. Additional analyses examined the proportions benefiting and the degree and durability of benefits.
Results
The Early-Active group had greater odds of improvement during the RCT phase (OR=1.66; 95% CI=1.17–2.35; P =0.005). This between-group difference increased until M12 and then progressively narrowed upon VNS activation in the Delayed-Active group, approaching parity by M36. Across both groups, emergence of new beneficiaries plateaued after 24 months of active VNS, but with participants progressively achieving higher degrees of benefit thereafter. Following activation, the Delayed-Active group had significant improvement in all six categorical outcome measures. Durability was strong across depressive symptoms, function, and quality-of-life outcomes. For participants receiving active VNS throughout, durability of response was 70% from M12 to M36.
Conclusions
Active VNS was associated with improved benefits for both treatment groups over years 2 and 3. New beneficiaries emerged during the first two years of active VNS with continued progression to higher levels of benefit in the third year. These clinical benefits were highly durable. ClinicalTrials.gov identifier: NCT03887715 .
