Daniel Moriarity
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.
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…
Inclusion Criteria: * Provision of signed and dated informed consent form * Stated willingness to comply with all study procedures and availability for the duration of the study * Male or female, aged 18+ years * Meet DSM-5 criteria for Major Depressive Disorder * baseline serum TNF-alpha (average of two samples in the same week) greater than 1.5 pg/mL * Taking a steady dose of Lexapro (escitalopram) for at least 4 weeks * Ability to take oral medication and physician-administered subcutaneous injection and be willing to adhere to the study protocol * For females of reproductive potential: us…
adalimumab biosimilar 100mg/mL
placebo injection of same volume as active medication for that visit
Arctuva estimate
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