NCT07845604 · Daniel Moriarity
Precision Depression Adalimumab Trial
(PDAT)
What this study is about
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.
View original scientific 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). 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.
Interventions
DRUG
Adalimumab Biosimilars Injection
adalimumab biosimilar 100mg/mL
OTHER
Placebo
placebo injection of same volume as active medication for that visit
Primary outcome measures
Change from baseline in individual somatic, affective, and motivational depressive symptoms, as measured by the Quick Inventory of Depressive Symptomatology (QIDS)
Time frame: From start of trial to the end of study (Day 57)
The QIDS (Trivedi et al., 2004; Rush et al., 2003) is a rating scale that assesses the nine criterion symptom domains designated by the American Psychiatric Association's (2000) DSM-IV to diagnose a major depressive episode. There are 16 items in the adult versions of the QIDS16 measuring the nine criterion symptom domains (sleep, sad mood, appetite/weight, concentration/decision making, self-view, thoughts of death or suicide, general interest, energy level, and restlessness/agitation) that define a major depressive episode according to the DSM-IV. The scores for three domains (sleep, appetite/weight, and restlessness/agitation) are based upon the maximum score (most pathological) of two or more questions for the total score analysis. Each of the remaining domains is rated by a single item. All domains are scored from 0 to 3, with higher scores reflecting greater psychopathology. Source: Yeung, A. et al. (2012). The QIDS. The Journal of nervous and mental disease, 200(8), 712-715.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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: use of highly effective contraception for at least 1 month
- Access to a phone or computer with a camera
Exclusion criteria
- Pregnant or breastfeeding
- Active, chronic or recurrent infection
- Known malignancy
- Current use of immune modulating medications
- 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
- Symptomatic hyponatremia
- Monoamine oxidase inhibitors (MAOI) use within 14 days
- Recent use of Rituxan (rituximab)
- Concomitant use of:
- Immunosuppressants
- Kineret (anakinra)
- Orencia (abatacept)
- Remicade (infliximab)
- Enbrel (etanercept)
- Cimzia (certolizumab pegol)
- Simponi (golimumab)
- Imuran (azathioprine)
- Purinethol (6-mercaptopurine)
- IV methylene blue
- Antiplatelet agents
- Strong anticoagulants (e.g. warfarin, large doses of NSAIDs)
- Other SSRIs, SNRIs, tryptophan
- Clinically relevant substance use disorder
- Known allergic reactions to components of adalimumab and/or escitalopram
- Treatment with another investigational drug or other intervention while participating in the study
Where
- Philadelphia, Pennsylvania
Collaborators
Brain & Behavior Research Foundation
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 29, 2026 · Source of record for eligibility and locations