Clinical characteristics and treatment exposure of patients with marked treatment-resistant unipolar major depressive disorder: A RECOVER trial report
Year: 2024
Type: article
Abstract: BACKGROUND: RECOVER is a randomized sham-controlled trial of vagus nerve stimulation and the largest such trial conducted with a psychiatric neuromodulation intervention. OBJECTIVE: 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. METHODS: 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). RESULTS: 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. CONCLUSIONS: 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. TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT03887715.
Source: Brain stimulation
Authors: 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
Institutions: Washington University in St. Louis, Sheppard and Enoch Pratt Hospital, Sheppard Pratt Health System, Columbia University, Alivation (United States), Stedman Clinical Trials, The University of Texas Health Science Center at Houston, Emory University, University of California, Riverside, Hoag Memorial Hospital Presbyterian, Center for Anxiety and Depression, Rush University Medical Center, Psychiatric Medicine Associates, University of Minnesota, University of Utah, Virginia Tech, LivaNova (United Kingdom), National University of Singapore, Duke University, Duke-NUS Medical School
Language: English
Subfield: Neurology
Field: Neuroscience
Domain: Life Sciences
Open Access status: gold
Estimated APC paid: $4,020
Funders: Gilead Sciences, Biogen, Teva Pharmaceutical Industries, University of Texas Southwestern Medical Center, Sunovion, LivaNova, Neurocrine Biosciences, Sage Therapeutics, Cerebrotech Medical Systems, Eisai, H. Lundbeck A/S, Idorsia Pharmaceuticals, National Institutes of Health, Genentech, Centers for Medicare and Medicaid Services
OpenAlex ID: W4393440396