At a glance
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An 8-Week Prospective Randomized, Controlled, Double-Blind Trial of the Genecept Assay ™ vs. Treatment-as-Usual to Evaluate Efficacy of Assay-Guided Treatment in Adults With Major Depressive Disorder (MDD)
In Brief
A clinical study evaluating Assay-guided treatment (AGT) and Treatment-as-usual (TAU) for Major Depressive Disorder. Completed, enrolled 305 participants across 23 sites.
Detailed Summary
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.
Study Details
Timeline
Interventions
The assay provides information to guide pharmacotherapeutic decisions personalized to a patient's genetic profile, to maximize improvement in symptomatology and minimize treatment failure and treatment intolerability.
Subjects are treated-as-usual without the aid of the assay.