NCT02902601

A Study to Investigate the Safety, Tolerability, and Pharmacodynamics of JNJ-54175446 in Participants With Major Depressive Disorder

Completed Phase 1 Last updated 27 April 2025

What this trial tests

Phase 1 trial testing JNJ-54175446, 600 mg in Depressive Disorder, Major in 70 participants. Completed in 7 June 2017.

Timeline

17 October 2016

Primary endpoint
2 June 2017

7 June 2017

Quick facts

Lead sponsor	Janssen Research & Development, LLC
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	70
Start date	17 October 2016
Primary completion	2 June 2017
Estimated completion	7 June 2017
Sites	4 locations across Netherlands, Germany

Drugs / interventions tested

• JNJ-54175446, 600 mg
• JNJ-54175446, 150 mg
• Placebo

Conditions studied

• Depressive Disorder, Major — all drugs for Depressive Disorder, Major →

Sponsor

Janssen Research & Development, LLC — full company profile →

Who can join

Adults 18 to 64, any sex, with Depressive Disorder, Major. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The primary purpose of this study is to investigate the safety and tolerability of JNJ 54175446 in participants with Major Depressive Disorder (MDD).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Recent Advances in CNS P2X7 Physiology and Pharmacology: Focus on Neuropsychiatric Disorders.
   Bhattacharya A. · · 2018 · cited 84× · PMID 29449810 · DOI 10.3389/fphar.2018.00030
2. Role of NLRP3 Inflammasome in Parkinson's Disease and Therapeutic Considerations.
   Nguyen LTN, Nguyen HD, Kim YJ, Nguyen TT, et al · · 2022 · cited 57× · PMID 35988226 · DOI 10.3233/jpd-223290
3. Characterization of the central nervous system penetrant and selective purine P2X7 receptor antagonist JNJ-54175446 in patients with major depressive disorder.
   Recourt K, de Boer P, van der Ark P, Benes H, et al · · 2023 · cited 48× · PMID 37482560 · DOI 10.1038/s41398-023-02557-5
4. Targeting Inflammatory-Mitochondrial Response in Major Depression: Current Evidence and Further Challenges.
   Visentin APV, Colombo R, Scotton E, Fracasso DS, et al · · 2020 · cited 45× · PMID 32351669 · DOI 10.1155/2020/2972968
5. P2X Receptors: Potential Therapeutic Targets for Symptoms Associated With Lung Cancer - A Mini Review.
   Mai Y, Guo Z, Yin W, Zhong N, et al · · 2021 · cited 17× · PMID 34268121 · DOI 10.3389/fonc.2021.691956
6. Pharmacological Monotherapy for Depressive Disorders: Current and Future-A Narrative Review.
   Gao K, Oruc EB, Koparal B. · · 2025 · cited 3× · PMID 40282849 · DOI 10.3390/medicina61040558
7. Differences in resting state and task-based EEG measures between patients with major depressive disorder and healthy controls.
   Kovacevic N, Meghdadi A, Berka C, Saad ZS, et al · · 2025 · cited 3× · PMID 40153921 · DOI 10.1016/j.clinph.2025.03.022
8. P2X7 receptor inhibition alleviates mania-like behavior independently of interleukin-1β
   Gölöncsér F, Baranyi M, Tod P, Maácz F, et al · · 2024