Precision Depression Adalimumab Trial
ConditionMajor Depressive Disorder (MDD)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorDaniel Moriarity
About 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Pregnant or breastfeeding
Active, chronic or recurrent infection
Known malignancy
Current use of immune modulating medications
Trial design
Design model
Parallel
Treatments tested in this trial
Adalimumab Biosimilars Injection
Drugadalimumab biosimilar 100mg/mL
Placebo
Other interventionplacebo injection of same volume as active medication for that visit
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Active Treatment ArmExperimental treatment 1 intervention
Group B: Placebo Comparison ArmPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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)Secondary outcomes
1
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)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Daniel Moriarity
Lead sponsor
University of Pennsylvania
Sponsor institution
Brain & Behavior Research Foundation
Collaborator
Source ClinicalTrials.gov