Symptoms of Major Depressive Disorder Scale (SMDDS): Performance of a Novel Patient-Reported Symptom Measure

•The Symptoms of Major Depressive Disorder Scale (SMDDS) was developed in accordance with the recommendations and scientific best practices set forth in the Food and Drug Administration's guidance for industry and recent scientific literature for achieving content validity of patient-reported outcome measures.•This observational study of 315 adults with major depressive disorder (MDD) provides the quantitative evidence supporting the measurement properties of the SMDDS.•The SMDDS can reliably and validly assess patient-reported MDD symptoms and has been qualified by the Food and Drug Administration for exploratory use in MDD treatment trials.