A Phase 2 interventional study of Adalimumab Biosimilars Injection and Placebo in Major Depressive Disorder (MDD), sponsored by Daniel Moriarity. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by Daniel Moriarity · Phase 2, Interventional, and Treatment
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:
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:
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.
Exclusion Criteria:
Concomitant use of:
80 mg adalimumab administered on Day 1 subcutaneously, then 40 mg adalimumab administered on Days 15, 29, and 43 subcutaneously by study psychiatrist.
Drug: Adalimumab Biosimilars Injection
0.8 mL saline placebo administered on Day 1 subcutaneously, then 0.4 mL saline placebo administered on Days 15, 29, and 43 subcutaneously by study psychiatrist.
Other: Placebo
adalimumab biosimilar 100mg/mL
placebo injection of same volume as active medication for that visit
Also known as: saline placebo
Change from baseline in individual somatic, affective, and motivational depressive symptoms, as measured by the Quick Inventory of Depressive Symptomatology (QIDS)
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.
Time frame: From start of trial to the end of study (Day 57)
Change from baseline in the total depression score, as measured by the Quick Inventory of Depressive Symptomatology
as for primary
Time frame: From start of trial to the end of study (Day 57)
Plan to share: Yes — Publication-specific
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
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