TY - JOUR
T1 - Clinical characteristics and treatment exposure of patients with marked treatment-resistant unipolar major depressive disorder
T2 - A RECOVER trial report
AU - Conway, Charles R.
AU - Aaronson, Scott T.
AU - Sackeim, Harold A.
AU - Duffy, Walter
AU - Stedman, Mary
AU - Quevedo, João
AU - Allen, Rebecca M.
AU - Riva-Posse, Patricio
AU - Berger, Matthew A.
AU - Alva, Gustavo
AU - Malik, Mohd Azfar
AU - Dunner, David L.
AU - Cichowicz, Ivan
AU - Luing, Heather
AU - Zajecka, John
AU - Nahas, Ziad
AU - Mickey, Brian J.
AU - Kablinger, Anita S.
AU - Kriedt, Christopher L.
AU - Bunker, Mark T.
AU - Lee, Ying Chieh (Lisa)
AU - Shy, Olivia
AU - Majewski, Shannon
AU - Olin, Bryan
AU - Tran, Quyen
AU - Rush, A. John
N1 - Publisher Copyright:
© 2024 The Authors
PY - 2024/3/1
Y1 - 2024/3/1
N2 - 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.
AB - 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.
KW - Electroconvulsive therapy
KW - Esketamine
KW - RECOVER trial
KW - Transcranial magnetic stimulation (TMS)
KW - Treatment-resistant depression (TRD)
KW - Vagus nerve stimulation (VNS)
UR - https://www.scopus.com/pages/publications/85189970664
U2 - 10.1016/j.brs.2024.03.016
DO - 10.1016/j.brs.2024.03.016
M3 - Article
C2 - 38574853
AN - SCOPUS:85189970664
SN - 1935-861X
VL - 17
SP - 448
EP - 459
JO - Brain Stimulation
JF - Brain Stimulation
IS - 2
ER -