Clinical characteristics and treatment exposure of patients with marked treatment-resistant unipolar major depressive disorder: A RECOVER trial report.
Charles R Conway, Scott T Aaronson, Harold A Sackeim, Walter Duffy, Mary Stedman, João Quevedo, Rebecca M Allen, Patricio Riva-Posse, Matthew A Berger, Gustavo Alva, Mohd Azfar Malik, David L Dunner, Ivan Cichowicz, Heather Luing, John Zajecka, Ziad Nahas, Brian J Mickey, Anita S Kablinger, Christopher L Kriedt, Mark T Bunker, Ying-Chieh Lisa Lee, Olivia Shy, Shannon Majewski, Bryan Olin, Quyen Tran, A John Rush
Brain stimulation January 1, 2024 DOI: 10.1016/j.brs.2024.03.016 via PubMed
Summary
AI-generated from the abstractPatients with treatment-resistant unipolar major depressive disorder who qualified for the RECOVER trial—the largest randomized sham-controlled study of vagus nerve stimulation for a psychiatric condition—had severe disability, a median of 11.0 prior failed antidepressant treatments, and high rates of suicidality (77% with suicidal ideation, 40% with previous suicide attempts). Seventy-one percent had received at least one prior interventional psychiatric treatment (electroconvulsive therapy, transcranial magnetic stimulation, or esketamine). Compared to those without such history, recipients of interventional treatments were younger, more severely depressed, had greater suicidal ideation, earlier onset of depression, and more failed medication trials.
Study at a glance
| Characteristics | Randomized sham-controlled trial (baseline description of qualified vs. not qualified participants) Peer reviewed |
|---|---|
| Sample size | 493 |
| Population | Unipolar major depressive disorder patients who qualified for the RECOVER trial |
| Intervention | vagus nerve stimulation |
| Topics | Esketamine |
| Keywords | Electroconvulsive therapy Recover trial Treatment-resistant depression trd Therapy-resistant depression |
| Citations | 16 |
| Registration | NCT03887715 |
| Key finding | RECOVER-qualified unipolar patients had marked treatment resistance and disability, and most had failed one or more prior interventional psychiatric treatments, which were associated with earlier onset, more severe presentation, and greater treatment resistance. |
Abstract
RECOVER is a randomized sham-controlled trial of vagus nerve stimulation and the largest such trial conducted with a psychiatric neuromodulation intervention. To describe pre-implantation baseline clinical characteristics and treatment history of patients with unipolar, major depressive disorder (MDD), overall and as a function of exposure to interventional psychiatric treatments (INTs), including electroconvulsive therapy, transcranial magnetic stimulation, and esketamine. Medical, psychiatric, and treatment records were reviewed by study investigators and an independent Study Eligibility Committee prior to study qualification. Clinical characteristics and treatment history (using Antidepressant Treatment History [Short] Form) were compared in those qualified (N = 493) versus not qualified (N = 228) for RECOVER, and among the qualified group as a function of exposure to INTs during the current major depressive episode (MDE). Unipolar MDD patients who qualified for RECOVER had marked TRD (median of 11.0 lifetime failed antidepressant treatments), severe disability (median WHODAS score of 50.0), and high rate of baseline suicidality (77% suicidal ideation, 40% previous suicide attempts). Overall, 71% had received at least one INT. Compared to the no INT group, INT recipients were younger and more severely depressed (QIDS-C, QIDS-SR), had greater suicidal ideation, earlier diagnosis of MDD, and failed more antidepressant medication trials. RECOVER-qualified unipolar patients had marked TRD and marked treatment resistance with most failing one or more prior INTs. Treatment with ≥1 INTs in the current MDE was associated with earlier age of MDD onset, more severe clinical presentation, and greater treatment resistance relative to patients without a history of INT. ClinicalTrials.gov Identifier NCT03887715.