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.
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Lenze EJ, Mulsant BH, Roose SP, et al. Trial of antidepressant augmentation vs. switching in treatment-resistant geriatric depression. N Engl J Med 2023. doi:10.1056/NEJMoa2204462. Online ahead of print.
References
- Optimizing Outcomes of Treatment-Resistant Depression in Older Adults (OPTIMUM): study design and treatment characteristics of the first 396 participants randomized.Am J Geriatr Psychiatr. 2019; 27: 1138-1152https://doi.org/10.1016/j.jagp.2019.04.005
Lenze EJ, Mulsant BH, Roose SP, et al. Trial of antidepressant augmentation vs. switching in treatment-resistant geriatric depression. N Engl J Med 2023. doi:10.1056/NEJMoa2204462. Online ahead of print.
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Published online: February 15, 2023
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© 2023 Published by Elsevier Inc. on behalf of American Association for Geriatric Psychiatry.
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- Optimizing Outcomes of Treatment-Resistant Depression in Older Adults (OPTIMUM): Study Design and Treatment Characteristics of the First 396 Participants RandomizedThe American Journal of Geriatric PsychiatryVol. 27Issue 10
- PreviewA challenge in the care of older adults with major depressive disorder is failure to respond to first-line pharmacotherapy: one-half to two-thirds of these older adults fail to remit with a selective serotonin reuptake inhibitor (SSRI) or a serotonin-norepinephrine reuptake inhibitor (SNRI).1 Late-life treatment-resistant depression (LLTRD) worsens medical outcomes,2 increases disability,3 hastens cognitive decline, and increases risk of dementia.4 The societal toll of unremitted depression is high: it is strongly associated with suicide,2 it carries the highest loss of quality of life, and has the highest mortality among chronic conditions.
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