Precision Depression Adalimumab Trial

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Daniel Moriarity
Study ID
NCT07845604
Phase
PHASE2
Status
Recruiting
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Conditions

  • Major Depressive Disorder (MDD)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

First listed
Sep 29, 2026
Start date
Sep 30, 2026
Status verified
Sep 2026
Primary completion
Jul 31, 2031
Completion
Sep 30, 2031

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Active Treatment Arm
    80 mg adalimumab administered on Day 1 subcutaneously, then 40 mg adalimumab administered on Days 15, 29, and 43 subcutaneously by study psychiatrist.
  • Placebo Comparator: Placebo Comparison Arm
    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.

Primary Outcome Measure

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) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of PennsylvaniaPhiladelphiaPennsylvania19104
Daniel P. Moriarity, PhD
[email protected]
(484) 808-5930

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By research site
University of Pennsylvania· Philadelphia, PA

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