Sex differences in a double-blind randomized clinical trial with minocycline: pilot findings on the key role of the immune system in treatment-resistant depressed female patients. (September 2021)

• Record Type: Journal Article
• Authors: Lombardo, Giulia; Nettis, Maria Antonietta; Hastings, Caitlin; Zajkowska, Zuzanna; Mariani, Nicole; Nikkheslat, Naghmeh; Worrell, Courtney; Enache, Daniela; McLaughlin, Anna; Kose, Melisa; Sforzini, Luca; Bogdanova, Anna; Cleare, Anthony; Young, Allan H.; Mondelli, Valeria; Pariante, Carmine Maria
• Is Part Of: Psychoneuroendocrinology. Volume 131(2021)Supplement
• Publication Date: 2021-09
• Subjects: Psychoneuroendocrinology -- Periodicals; Endocrinology -- Periodicals; Neurology -- Periodicals; Psychiatry -- Periodicals; Neuropsychoendocrinologie -- Périodiques; 616.8
• DOI: 10.1016/j.psyneuen.2021.105490
• Languages: English
• ISSNs: 0306-4530

Abstract

Abstract : Background: The Minocycline in Depression (MINDEP) study is a 4-weeks double-blind, placebo-controlled clinical trial, investigating the efficacy of minocycline in treatment resistant depressed (TRD) patients with major depressive disorder, and C-reactive protein (CRP) ≥ 1 mg/L. Methods: We explored sex differences in the effects of study arms and CRP groups (CRP ≥ 3 mg/L; CRP < 3 mg/L) on HAMD-17 variation from baseline to week-4. Results: Independent samples t-test detected a significant difference between minocycline (M) and placebo (PL) groups only in males but not females, with M group (N=8) showing greater improvement in comparison with PL group (N=9) (p=0.046). However, M female group with CRP ≥ 3 mg/L (N=3) showed the greatest clinical improvement in comparison with the other female groups (p<0.05 vs. all groups). General linear model univariate analysis confirmed the significant interaction between study arms and CRP groups in females (p=0.005). Conclusion: These pilot findings suggest that TRD male patients may benefit from minocycline add-on treatment independently of their baseline inflammatory levels, while TRD female patients may benefit from minocycline only if having higher baseline inflammatory levels.