Precision Psychiatry: Anti-inflammatory Medication in Immuno-metabolic Depression

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

As the role of (neuro)inflammation in depression is emerging, augmentation of antidepressant treatments with anti-inflammatory drugs such as celecoxib has shown encouraging preliminary results. However, inflammation is not present in all depressed patients. Depression is heterogeneous: patients express diverse and sometimes opposing symptoms and biological profiles. The investigators of the present trial recently introduced the concept of ImmunoMetabolic Depression (IMD), characterized by the clustering of inflammatory/metabolic dysregulations and atypical, energy-related symptoms (hyperphagia, weight gain, hypersomnia, fatigue and leaden paralysis), and present in approximately 30% of cases. Converging evidence suggests that in this subgroup of depression cases, inflammation may exert a crucial pathobiological mechanism, representing therefore an actionable therapeutic target. In this trial IMD will be applied as a tool to personalize treatment, by matching depressed subjects with IMD with a targeted anti-inflammatory add-on treatment. In this study, 140 persons with IMD will be selected. In this specific group of patients, the investigators will test whether celecoxib add-on (400 mg/d) is more effective than placebo in the treatment of depression through a 12-week double-blind, randomized (1:1), placebo-controlled trial. By selecting specifically depressed patients with IMD, the proposed treatment selectively targets key inflammatory pathophysiological pathways to enhance clinical outcome for depression. This personalized approach is expected to lead to large health gains for a sizable proportion of patients. The main hypothesis is that the group of patients with IMD receiving TAU + celecoxib, as compared to the TAU + placebo, will show a better symptom course over the 12-week follow-up.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• DSM-5 diagnosis of MDD confirmed with clinical interview (MINI-S voor DSM-5 Nederlandse versie 2019)

• Currently using pharmacotherapy (e.g., SSRI, SNRI, TCA, TetraCA, MAOI, other antidepressant \[bupropion, vortioxetine, agomelatine\])) and/or psychotherapy. Subjects should be on the current treatment for at least 4 weeks

• IDS-SR score ≥26 (moderate to severe depressive symptoms) and a score ≥6 on atypical, energy-related symptoms scale from IDS

• CRP \> 1mg/L

• A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies: 1) is not a woman of child bearing potential (WOCBP); 2) Is a WOCBP and agrees to use, or is already using, a contraceptive method during the intervention period and up to 1 month after the intervention

• Signed informed consent

Locations
Other Locations
Netherlands
Department of Psychiatry Amsterdam UMC
RECRUITING
Amsterdam
Contact Information
Primary
Joël Zwiep, MSc
j.zwiep@amsterdamumc.nl
+31629680809
Backup
Yuri Milaneschi, PhD
y.milaneschi@amsterdamumc.nl
Time Frame
Start Date: 2022-09-28
Estimated Completion Date: 2026-07
Participants
Target number of participants: 140
Treatments
Experimental: Celecoxib
Celecoxib 400 mg/day, 2 capsules (200 mg) daily, 12 weeks
Placebo_comparator: Placebo
Placebo, 2 capsules daily, 12 weeks
Related Therapeutic Areas
Sponsors
Collaborators: Netherlands Brain Foundation
Leads: Amsterdam UMC, location VUmc

This content was sourced from clinicaltrials.gov