At a glance
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Establishing Moderators and Biosignatures of Antidepressant Response for Clinical Care (EMBARC) for Depression
In Brief
A Phase 2 clinical trial evaluating Sertraline, Placebo, and 1 other intervention for Depression. Completed, enrolled 296 participants across 4 sites.
Detailed Summary
This study will examine multiple carefully selected clinical and biological markers, using both existing state-of-the-art technologies as well as pioneering, innovative approaches. The study is designed to identify moderators and mediators of treatment response for depression in order to specify a biosignature of treatment response for depression. Evaluation of the usefulness of these markers in a carefully conducted clinical trial comparing an antidepressant to placebo will assist in developing a Depression Treatment Response Index (DTRI) to help clinicians match treatments to patients with MDD, resulting in timely selection of treatments best suited for individual patients and thus approaching personalized treatment. The resulting index provides a truly novel means of synthesizing the contribution of key clinical and biological parameters in an easy to use tool for clinical care.
Study Details
Timeline
Interventions
50-200mg/day
1-4 pills per day
150-450 mg/day