Efficacy of celecoxib add-on treatment for immuno-metabolic depression: Protocol of the INFLAMED double-blind placebo-controlled randomized controlled trial

被引：14

作者：

Zwiep, J. C. ^{[1
,2
]}

Bet, P. M. ^{[4
]}

Rhebergen, D. ^{[1
,2
,5
]}

Nurmohamed, M. T. ^{[6
]}

Vinkers, C. H. ^{[1
,2
,3
,7
,8
]}

Penninx, B. W. J. H. ^{[1
,2
,3
]}

Milaneschi, Y. ^{[1
,2
,3
]}

Lamers, F. ^{[1
,2
]}

机构：

[1] Vrije Univ, Dept Psychiat, Amsterdam UMC, Boelelaan 1117,1118, NL-1081 HV Amsterdam, Netherlands

[2] Amsterdam Publ Hlth, Mental Hlth Program, Amsterdam, Netherlands

[3] Amsterdam Neurosci, Mood Anxiety Psychosis Sleep & Stress Program, Amsterdam, Netherlands

[4] Vrije Univ, Dept Clin Pharmacol & Pharm, Amsterdam UMC, De Boelelaan 1117,1118, NL-1081 HV Amsterdam, Netherlands

[5] GGZ Centraal Mental Hlth Care, Dept Res, Amersfoort, Netherlands

[6] Vrije Univ, Dept Rheumatol, Amsterdam UMC, Boelelaan 1117,1118, NL-1081 HV Amsterdam, Netherlands

[7] Vrije Univ Amsterdam, Dept Anat & Neurosci, Amsterdam UMC, Boelelaan 1117,1118, NL-1081 HV Amsterdam, Netherlands

[8] GGZ InGeest Mental Hlth Care, NL-1081 HJ Amsterdam, Netherlands

来源：

BRAIN BEHAVIOR & IMMUNITY-HEALTH | 2023年 / 27卷

关键词：

Major depressive disorder; Inflammation; Metabolism; Treatment; Randomized controlled trial; Anti-inflammatory medication; Celecoxib; SYMPTOMATOLOGY IDS; QUESTIONNAIRE; RELIABILITY; SLEEPINESS; INVENTORY; VALIDITY; FATIGUE; SCALE;

D O I：

10.1016/j.bbih.2022.100585

中图分类号：

R392 [医学免疫学]; Q939.91 [免疫学];

学科分类号：

100102 ;

摘要：

Introduction: As the role of (neuro)inflammation in depression pathophysiology is emerging, augmentation of antidepressant treatments with anti-inflammatory drugs have shown beneficial results, but not consistently across all studies. Inconsistencies may be due to depression biological and clinical heterogeneity. Immuno-Metabolic Depression (IMD) has been put forward as a form of depression characterized by the clustering of low-grade inflammation, metabolic dysregulations and atypical, energy-related symptoms (overeating, weight gain, hypersomnia, fatigue and leaden paralysis). IMD features are present in similar to 30% of patients with Major Depressive Disorder (MDD). By selecting these specific patients, directly targeting inflammation may reduce depressive symptoms.Methods: and analysis INFLAMED is a double-blind randomized controlled trial. 140 MDD patients with IMD characteristics (MDD with Inventory of Depressive Symptomatology (IDS) >= 26, IDS atypical, energy related symptoms >= 6, C-Reactive Protein (CRP) > 1 mg/L) will receive either 400 mg celecoxib per day or matching placebo for a period of 12 weeks. Biological, physical and interview data will be collected after 2, 6 and 12 weeks of starting the intervention. Questionnaires will be sent out bi-weekly during the study period. The main study outcome is the IDS (30-item self-report) total score during 12-week follow-up. Secondary study outcomes include response, remission, adverse side effects, symptom profiles (atypical, energy-related symptoms), fatigue, food craving, sleep, anxiety symptoms, functioning, pain, and optionally, microbiome composition. Explorative analyses will be performed on the role of CRP, IL-6, TNF-alpha, cholesterol, triglycerides, glucose, BMI, waist and hip circumference.Ethics and dissemination: This protocol has been approved by the Medical Ethics Review Board of the Amsterdam UMC, location VUmc (2022.0015) on 2-6-2022, as well as by the competent authority in The Netherlands: CCMO, on 3-8-2022.

引用

页数：7