TY - JOUR
T1 - Corrigendum to Optimizing Outcomes of Treatment-Resistant Depression in Older Adults (OPTIMUM)
T2 - Study Design and Treatment Characteristics of the First 396 Participants Randomized. Am J Geriatr Psychiatry 2019;27(10):1138–1152. doi: 10.1016/j.jagp.2019.04.005 (The American Journal of Geriatric Psychiatry (2019) 27(10) (1138–1152), (S1064748119303380), (10.1016/j.jagp.2019.04.005))
AU - Cristancho, Pilar
AU - Lenard, Emily
AU - Lenze, Eric J.
AU - Miller, J. Philip
AU - Brown, Patrick J.
AU - Roose, Steven P.
AU - Montes-Garcia, Carolina
AU - Blumberger, Daniel M.
AU - Mulsant, Benoit H.
AU - Lavretsky, Helen
AU - Rollman, Bruce L.
AU - Reynolds, Charles F.
AU - Karp, Jordan F.
N1 - Publisher Copyright:
© 2023
PY - 2023/6
Y1 - 2023/6
N2 - In the paper titled, “Optimizing Outcomes of Treatment-Resistant Depression in Older Adults (OPTIMUM): Study Design and Treatment Characteristics of the First 396 Participants Randomized,” published by Cristancho and co-authors in October 2019,1 there were errors in the text. In short, the paper described details about the methodology of the clinical trial, Optimizing Outcomes of Treatment-Resistant Depression in Older Adults (OPTIMUM). The paper stated in several places that there were several primary effectiveness outcomes of OPTIMUM. For example, in the abstract, the paper stated, “Primary outcomes include: 1) symptom remission (Montgomery Asberg Depression scale ≤10); 2) psychological well-being, comprising positive affect, general life satisfaction, and purpose…” The statistical analysis plan of OPTIMUM has only one primary outcome. This is Psychological Well-being, which combines two subscales of positive affect and general life satisfaction from the NIH Toolbox. OPTIMUM's statistical analysis plan does not have a plan to correct for multiple effectiveness outcomes. Remission from depression, although an important outcome to clinicians, was a secondary outcome. The OPTIMUM trial is now complete and findings have been published elsewhere.2
AB - In the paper titled, “Optimizing Outcomes of Treatment-Resistant Depression in Older Adults (OPTIMUM): Study Design and Treatment Characteristics of the First 396 Participants Randomized,” published by Cristancho and co-authors in October 2019,1 there were errors in the text. In short, the paper described details about the methodology of the clinical trial, Optimizing Outcomes of Treatment-Resistant Depression in Older Adults (OPTIMUM). The paper stated in several places that there were several primary effectiveness outcomes of OPTIMUM. For example, in the abstract, the paper stated, “Primary outcomes include: 1) symptom remission (Montgomery Asberg Depression scale ≤10); 2) psychological well-being, comprising positive affect, general life satisfaction, and purpose…” The statistical analysis plan of OPTIMUM has only one primary outcome. This is Psychological Well-being, which combines two subscales of positive affect and general life satisfaction from the NIH Toolbox. OPTIMUM's statistical analysis plan does not have a plan to correct for multiple effectiveness outcomes. Remission from depression, although an important outcome to clinicians, was a secondary outcome. The OPTIMUM trial is now complete and findings have been published elsewhere.2
UR - http://www.scopus.com/inward/record.url?scp=85151916682&partnerID=8YFLogxK
U2 - 10.1016/j.jagp.2023.02.042
DO - 10.1016/j.jagp.2023.02.042
M3 - Comment/debate
C2 - 36922318
AN - SCOPUS:85151916682
SN - 1064-7481
VL - 31
SP - 472
EP - 473
JO - American Journal of Geriatric Psychiatry
JF - American Journal of Geriatric Psychiatry
IS - 6
ER -