Genecept Assay™ vs. Treatment-as-Usual to Evaluate Efficacy of Assay-Guided Treatment in Adults With MDD

In this randomized clinical trial, subjects will be assigned to either an assay-guided treatment condition (AGT) or a treatment-as-usual condition (TAU). All subjects will provide a DNA sample at the Screening Visit for the Genecept Assay ™. In the AGT condition, assay results will be provided to the treating investigator, who will use the results to guide antidepressant pharmacotherapy. In the TAU condition, the investigator will treat the subjects without the knowledge of the pharmacogenetic testing results. Assay results for all subjects will be provided to the investigator once all Week 8 visit procedures have been completed. Raters of the primary endpoint assessment and subjects will remain blinded to treatment assignment.

This study compares efficacy and safety outcomes in Major Depressive Disorder (MDD) adult patients randomized to assay-guided treatment (AGT) or treatment-as-usual (TAU). The treatment duration will be 8-weeks. Subjects will be assessed at visits at Week 2, 4, 6 and 8. Approximately 300 subjects will be randomized 1:1 to the two treatment group (AGT and TAU). This is a multi-center trial, with approximately 25 sites in the US. Randomization will be by IWRS. The treating investigator will be unblinded to treatment assignment (necessarily). Other site staff, sponsor staff (including site monitors) and all others will be blinded to treatment assignment for the duration of the subject's participation in the study. The (blinded) rater for the primary endpoint, the SIGH-D-17 Hamilton Depression Scale, will have no other contact with the subject such as collection of screening data, follow-up assessments, documentation of adverse events, etc. Blinded raters will not discuss subjects with other study staff. After recruitment for main study is completed, an additional 70 subjects , age 65 years and older will be randomized to the Exploratory Elderly MDD Study. This follow-on sub-study will apply all procedures of the main study to this elderly population subset.