TY - JOUR
T1 - Statistical analysis plan for stage 1 EMBARC (Establishing Moderators and Biosignatures of Antidepressant Response for Clinical Care) study
AU - Petkova, Eva
AU - Ogden, R. Todd
AU - Tarpey, Thaddeus
AU - Ciarleglio, Adam
AU - Jiang, Bei
AU - Su, Zhe
AU - Carmody, Thomas
AU - Adams, Philip
AU - Kraemer, Helena C.
AU - Grannemann, Bruce D.
AU - Oquendo, Maria A.
AU - Parsey, Ramin
AU - Weissman, Myrna
AU - McGrath, Patrick J.
AU - Fava, Maurizio
AU - Trivedi, Madhukar H.
N1 - Publisher Copyright:
© 2017 The Authors
PY - 2017/6/1
Y1 - 2017/6/1
N2 - Antidepressant medications are commonly used to treat depression, but only about 30% of patients reach remission with any single first-step antidepressant. If the first-step treatment fails, response and remission rates at subsequent steps are even more limited. The literature on biomarkers for treatment response is largely based on secondary analyses of studies designed to answer primary questions of efficacy, rather than on a planned systematic evaluation of biomarkers for treatment decision. The lack of evidence-based knowledge to guide treatment decisions for patients with depression has lead to the recognition that specially designed studies with the primary objective being to discover biosignatures for optimizing treatment decisions are necessary. Establishing Moderators and Biosignatures of Antidepressant Response in Clinical Care (EMBARC) is one such discovery study. Stage 1 of EMBARC is a randomized placebo controlled clinical trial of 8 week duration. A wide array of patient characteristics is collected at baseline, including assessments of brain structure, function and connectivity along with electrophysiological, biological, behavioral and clinical features. This paper reports on the data analytic strategy for discovering biosignatures for treatment response based on Stage 1 of EMBARC.
AB - Antidepressant medications are commonly used to treat depression, but only about 30% of patients reach remission with any single first-step antidepressant. If the first-step treatment fails, response and remission rates at subsequent steps are even more limited. The literature on biomarkers for treatment response is largely based on secondary analyses of studies designed to answer primary questions of efficacy, rather than on a planned systematic evaluation of biomarkers for treatment decision. The lack of evidence-based knowledge to guide treatment decisions for patients with depression has lead to the recognition that specially designed studies with the primary objective being to discover biosignatures for optimizing treatment decisions are necessary. Establishing Moderators and Biosignatures of Antidepressant Response in Clinical Care (EMBARC) is one such discovery study. Stage 1 of EMBARC is a randomized placebo controlled clinical trial of 8 week duration. A wide array of patient characteristics is collected at baseline, including assessments of brain structure, function and connectivity along with electrophysiological, biological, behavioral and clinical features. This paper reports on the data analytic strategy for discovering biosignatures for treatment response based on Stage 1 of EMBARC.
KW - Combining biomarkers
KW - Differential treatment response index
KW - Moderator
KW - Optimizing treatment decisions
KW - Precision medicine
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U2 - 10.1016/j.conctc.2017.02.007
DO - 10.1016/j.conctc.2017.02.007
M3 - Article
C2 - 28670629
AN - SCOPUS:85014508995
SN - 2451-8654
VL - 6
SP - 22
EP - 30
JO - Contemporary Clinical Trials Communications
JF - Contemporary Clinical Trials Communications
ER -