Adalimumab added to escitalopram for adults with major depressive disorder
Tests adalimumab versus placebo alongside escitalopram in adults with major depressive disorder.
Plain-language title generated from the registry record
Registry title: Precision Depression Adalimumab Trial
Key facts
- Where
- Philadelphia, United StatesSee the site
- Phase
- Phase 2
Where in United States
- University of PennsylvaniaPhiladelphia, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Daniel Moriarity
- Trial code
- NCT07845604
- Record updated
- 29 September 2026
- Original description
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).Read full original descriptionShow less
An Precision Immunopsychiatric Pharmacological Probe of Adalimumab as an Anti-depressant
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.
Inclusion: 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: use of highly effective contraception for at least 1 month; Access to a phone or computer with a camera.
Exclusion: Current use of immune modulating medications; Monoamine oxidase inhibitors (MAOI) use within 14 days; Concomitant use of:; Immunosuppressants; Kineret (anakinra); Orencia (abatacept); Remicade (infliximab); Enbrel (etanercept); Cimzia (certolizumab pegol); Simponi (golimumab); Imuran (azathioprine); Purinethol (6-mercaptopurine); Linezolid; IV methylene blue; Pimozide; Antiplatelet agents; Strong anticoagulants (e.g. warfarin, large doses of NSAIDs); Other SSRIs, SNRIs, tryptophan; Treatment with another investigational drug or other intervention while participating in the study; Active, chronic or recurrent infection; Known malignancy; Immunocompromised, current autoimmune condition or history of severe immune condition (e.g., history of cancer, HIV/AIDS); History of, or positive test for, Hepatitis B surface antigen or core antibody positivity or tuberculosis (TB); Congestive heart failure; History of demyelinating disease (multiple sclerosis (MS), optic neuritis, Guillain-Barre syndrome); History of seizure disorder; Clinically relevant substance use disorder; Known allergic reactions to components of adalimumab and/or escitalopram; Pregnant or breastfeeding; Symptomatic hyponatremia; Recent use of Rituxan (rituximab).