Adalimumab for Major Depressive Disorder
(PDAT Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
Daniel P. Moriarity, PhD
Principal Investigator
University of Pennsylvania
Are You a Good Fit for This Trial?
This trial is for adults diagnosed with Major Depressive Disorder who are currently taking Lexapro (escitalopram) as an antidepressant. Participants must be able to attend clinic visits every two weeks and complete daily short surveys during the study.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Adalimumab Biosimilars Injection
Trial Overview
The study tests whether adding adalimumab (an anti-inflammatory injection) to ongoing Lexapro treatment helps improve depression symptoms, compared to a placebo injection. Participants receive injections every two weeks over about two months.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
80 mg adalimumab administered on Day 1 subcutaneously, then 40 mg adalimumab administered on Days 15, 29, and 43 subcutaneously by study psychiatrist.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Daniel Moriarity
Lead Sponsor
Brain & Behavior Research Foundation
Collaborator
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