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.

Timeline

Start

2026-09

Primary completion

2031-07

Completion

2031-09

Publications

• Background Menter A, Augustin M, Signorovitch J, Yu AP, Wu EQ, Gupta SR, Bao Y, Mulani P. The effect of adalimumab on reducing depression symptoms in patients with moderate to severe psoriasis: a randomized clinical trial. J Am Acad Dermatol. 2010 May;62(5):812-8. doi: 10.1016/j.jaad.2009.07.022. Epub 2010 Mar 9.
• Background Abbasian F, Bagheri S, Moradi K, Keykhaei M, Etemadi A, Shalbafan M, Shariati B, Vaseghi S, Samsami FS, Akhondzadeh S. Evidence for Anti-inflammatory Effects of Adalimumab in Treatment of Patients With Major Depressive Disorder: A Pilot, Randomized, Controlled Trial. Clin Neuropharmacol. 2022 Sep-Oct 01;45(5):128-134. doi: 10.1097/WNF.0000000000000518. Epub 2022 Sep 7.

Drugs

Indications