N-acetylcysteine as add-on to antidepressant medication in therapy refractory major depressive disorder patients with increased inflammatory activity: study protocol of a double-blind randomized placebo-controlled trial

被引:19
作者
Yang, Chenghao [1 ,2 ,3 ]
Bosker, Fokko J. [2 ,3 ]
Li, Jie [1 ]
Schoevers, Robert A. [2 ,3 ]
机构
[1] Tianjin Anding Hosp, Tianjin Mental Hlth Inst, 13 Liulin Rd, Tianjin, Peoples R China
[2] Univ Groningen, Univ Med Ctr Groningen, Dept Psychiat, Hanzepl 1, NL-9700 RB Groningen, Netherlands
[3] Univ Groningen, Res Sch Behav & Cognit Neurosci BCN, Hanzepl 1, NL-9700 RB Groningen, Netherlands
来源
BMC PSYCHIATRY | 2018年 / 18卷
关键词
N-acetylcysteine; Treatment resistant depression; Inflammatory activity; Biomarkers; Brain activity; TREATMENT-RESISTANT DEPRESSION; CONNECTIVITY; SYMPTOMS; COPD;
D O I
10.1186/s12888-018-1845-1
中图分类号
R749 [精神病学];
学科分类号
100205 ;
摘要
Background: A subgroup of depressed patients with increased inflammatory activity was shown to be more susceptible to develop Treatment Resistant Depression (TRD). Earlier studies with anti-inflammatory drugs have shown benefits in the treatment of major depressive disorder (MDD), but the effects are expected to be higher in patients with increased inflammatory activity. Supplementation of N-acetylcysteine (NAC) to ongoing antidepressant therapy may positively influence outcome of depression treatment in these patients. Therefore, this study aims to investigate the efficacy of NAC supplementation in patients with insufficient response to standard antidepressant treatment, and to explore potential roles of inflammation and oxidative stress involved in the alleged pathophysiological processes of TRD. Methods/design: A double-blind randomized placebo-controlled study comparing NAC versus placebo as add-on medication to antidepressant treatment with 12-week treatment and 8-week follow up in patients with TRD and increased inflammatory activity. Apart from clinical efficacy defined as the change in Hamilton Depression Rating Scale (HAMD)-17 score, secondary outcomes include changes in pathophysiological mechanisms related to depression as well as changes in local brain activity (functional Magnetic Resonance Imaging, fMRI) and white matter integrity (Diffusion Tensor Imaging, DTI). Importantly, sole patients with CRP levels with values between 0.85 and 10 mg/L will be included. Discussion: This is the first clinical trial taking both TRD and increased inflammatory activity as inclusion criteria. This study will provide reliable evidence for the efficacy of NAC in patients with TRD displaying increased inflammatory activity. And this study also will help explore further the roles of inflammation and oxidative stress involved in the alleged pathophysiological processes of TRD.
引用
收藏
页数:11
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共 25 条
  • [1] N-acetyl cysteine for depressive symptoms in bipolar disorder - A double-blind randomized placebo-controlled trial
    Berk, Michael
    Copolov, David L.
    Dean, Olivia
    Lu, Kristy
    Jeavons, Sue
    Schapkaitz, Ian
    Anderson-Hunt, Murray
    Bush, Ashley I.
    [J]. BIOLOGICAL PSYCHIATRY, 2008, 64 (06) : 468 - 475
  • [2] The Efficacy of Adjunctive N-Acetylcysteine in Major Depressive Disorder: A Double-Blind, Randomized, Placebo-Controlled Trial
    Berk, Michael
    Dean, Olivia M.
    Cotton, Sue M.
    Jeavons, Susan
    Tanious, Michelle
    Kohlmann, Kristy
    Hewitt, Karen
    Moss, Kirsteen
    Allwang, Christine
    Schapkaitz, Ian
    Robbins, Jenny
    Cobb, Heidi
    Ng, Felicity
    Dodd, Seetal
    Bush, Ashley I.
    Malhi, Gin S.
    [J]. JOURNAL OF CLINICAL PSYCHIATRY, 2014, 75 (06) : 628 - U95
  • [3] The promise of N-acetylcysteine in neuropsychiatry
    Berk, Michael
    Malhi, Gin S.
    Gray, Laura J.
    Dean, Olivia M.
    [J]. TRENDS IN PHARMACOLOGICAL SCIENCES, 2013, 34 (03) : 167 - 177
  • [4] Resting state default-mode network connectivity in early depression using a seed region-of-interest analysis: Decreased connectivity with caudate nucleus
    Bluhm, Robyn
    Williamson, Peter
    Lanius, Ruth
    Theberge, Jean
    Densmore, Maria
    Bartha, Robert
    Neufeld, Richard
    Osuch, Elizabeth
    [J]. PSYCHIATRY AND CLINICAL NEUROSCIENCES, 2009, 63 (06) : 754 - 761
  • [5] The Four-Year Course of Major Depressive Disorder: The Role of Staging and Risk Factor Determination
    Boschloo, Lynn
    Schoevers, Robert A.
    Beekman, Aartjan T. F.
    Smit, Johannes H.
    van Hemert, Albert M.
    Penninx, Brenda W. J. H.
    [J]. PSYCHOTHERAPY AND PSYCHOSOMATICS, 2014, 83 (05) : 279 - 288
  • [6] Lack of clinical therapeutic benefit of antidepressants is associated overall activation of the inflammatory system
    Carvalho, L. A.
    Torre, J. P.
    Papadopoulos, A. S.
    Poon, L.
    Juruena, M. F.
    Markopoulou, K.
    Cleare, A. J.
    Pariante, C. M.
    [J]. JOURNAL OF AFFECTIVE DISORDERS, 2013, 148 (01) : 136 - 140
  • [7] Effect of high-dose N-acetylcysteine on airway geometry, inflammation, and oxidative stress in COPD patients
    De Backer, Jan
    Vos, Wim
    Van Holsbeke, Cedric
    Vinchurkar, Samir
    Claes, Rita
    Parizel, Paul M.
    De Backer, Wilfried
    [J]. INTERNATIONAL JOURNAL OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE, 2013, 8 : 569 - 579
  • [8] Prospective, long-term, multicenter study of the naturalistic outcomes of patients with treatment-resistant depression
    Dunner, David L.
    Rush, A. John
    Russell, James M.
    Burke, Michael
    Woodard, Stacy
    Wingard, Peggy
    Allen, John
    [J]. JOURNAL OF CLINICAL PSYCHIATRY, 2006, 67 (05) : 688 - 695
  • [9] Is there an association between peripheral immune markers and structural/functional neuroimaging findings?
    Frodl, Thomas
    Amico, Francesco
    [J]. PROGRESS IN NEURO-PSYCHOPHARMACOLOGY & BIOLOGICAL PSYCHIATRY, 2014, 48 : 295 - 303
  • [10] Attention Deficit and Hyperactivity Disorder Scores Are Elevated and Respond to N-Acetylcysteine Treatment in Patients With Systemic Lupus Erythematosus
    Garcia, Ricardo J.
    Francis, Lisa
    Dawood, Maha
    Lai, Zhi-wei
    Faraone, Stephen V.
    Perl, Andras
    [J]. ARTHRITIS AND RHEUMATISM, 2013, 65 (05): : 1313 - 1318