Precision Depression Adalimumab Trial

Summary

The goal of this clinical trial is to learn if the anti-inflammatory medication adalimumab improves depressive symptoms in adults with Major Depressive Disorder (MDD) who are already taking the anti-depressant medication Lexapro (escitalopram). The main questions it aims to answer are: 1. Does adalimumab improve the symptoms of some patients with MDD who are already taking an anti-depressant? 2. What characteristics predict for whom adalimumab has anti-depressant properties. Researchers will compare adalimumab to a placebo (a look-alike substance that contains no drug) to see if adalimumab works to improve depressive symptoms as an add-on drug to the anti-depressant Lexapro (escitalopram). For these primary aims the participants will: 1. Visit the clinic once every 2 weeks for a checkups and injection of adalimumab or placebo from the study psychiatrist (Day 1, 15, 29, and 43 for injections) 2. Complete short (\<5 min) daily surveys for the 57 day duration of the study.

Detailed Description

This is a 57-day intensive longitudinal study of 60 adult subjects with Major Depressive Disorder and elevated baseline tumor necrosis factor (TNF) levels. A triple-blind, placebo-controlled pharmacological investigation of adalimumab as an adjunctive medication to escitalopram will be conducted to determine anti-depressant efficacy of adalimumab. Patients will be screened for depression, health concerns, and a minimum of 1.5 pg/mL TNFa. It is hypothesized that adalimumab will lead to improved treatment outcomes (specifically somatic/neurovegetative symptoms). It is hypothesized that, if more symptoms than somatic/neurovegetative respond, they will do so less quickly than somatic/neurovegetative symptoms. Enrolled participants will be randomized in a 2:1 ratio to adjunctive adalimumab or placebo in addition to the participant's regular dose of escitalopram each day (both conditions). Patients will be matched for sex. Enrolled patients will attend 4 clinic visits, at which point they will receive injections of adalimumab or placebo from the study psychiatrist (Day 1, 15, 29, and 43 for injections), in addition to clinician-assessed measures. Daily self-report assessments of depression symptoms will be collected for 57 days.

Eligibility Criteria

Interventions