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首页> 外文期刊>Clinical Psychopharmacology and Neuroscience >Protocol and Rationale-The Efficacy of Minocycline as an Adjunctive Treatment for Major Depressive Disorder: A Double Blind, Randomised, Placebo Controlled Trial
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Protocol and Rationale-The Efficacy of Minocycline as an Adjunctive Treatment for Major Depressive Disorder: A Double Blind, Randomised, Placebo Controlled Trial

机译：协议和理论依据-米诺环素作为主要抑郁症的辅助治疗的功效：双盲，随机，安慰剂对照试验

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While current pharmacotherapies are efficacious, there remain a clear shortfall between symptom remission and functional recovery. With the explosion in our understanding of the biology of these disorders, the time is ripe for the investigation of novel therapies. Recently depression is conceptualized as an immune-inflammatory and nitro-oxidative stress related disorder. Minocycline is a tetracycline antibiotic that has anti-inflammatory, pro-oxidant, glutamatergic, neurotrophic and neuroprotective properties that make it a viable target to explore as a new therapy. This double blind, randomised, placebo controlled adjunctive trial will investigate the benefits of 200 mg/day of minocycline treatment, in addition to any usual treatment, as an adjunctive treatment for moderate-severe major depressive disorder. Sixty adults are being randomised to 12 weeks of treatment (with a 4 week follow-up post-discontinuation). The primary outcome measure for the study is mean change on the Montgomery-Asberg Depression Rating Scale (MADRS), with secondary outcomes including the Social and Occupational Functioning Assessment Scale (SOFAS), Clinical Global Impressions (CGI), Hamilton Rating Scale for Anxiety (HAM-A), Patient Global Impression (PGI), Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) and Range of Impaired Functioning Tool (LIFE-RIFT). Biomarker analyses will also be conducted at baseline and week 12. The study has the potential to provide new treatment targets, both by showing efficacy with a new class of 'antidepressant' but also through the analysis of biomarkers that may further inform our understanding of the pathophysiology of unipolar depression.
机译：尽管目前的药物疗法有效，但症状缓解和功能恢复之间仍然存在明显的不足。随着我们对这些疾病的生物学认识的突飞猛进，研究新疗法的时机已经成熟。最近，抑郁症被概念化为与免疫炎症和硝基氧化应激相关的疾病。 Minocycline是一种四环素抗生素，具有抗炎，促氧化剂，谷氨酸能，神经营养和神经保护特性，使其成为可行的新疗法。这项双盲，随机，安慰剂对照的辅助试验将研究200毫克/天的米诺环素治疗以及任何常规治疗作为中重度重度抑郁症的辅助治疗的益处。 60名成人被随机分配至治疗12周（停药后进行4周随访）。这项研究的主要结局指标是蒙哥马利-阿斯伯格抑郁量表（MADRS）的平均变化，次要结局包括社会和职业功能评估量表（SOFAS），临床总体印象（CGI），汉密尔顿焦虑量表（ HAM-A），患者总体印象（PGI），生活质量和满意度调查表（Q-LES-Q）和功能受损的工具范围（LIFE-RIFT）。生物标志物分析也将在基线和第12周进行。这项研究有可能提供新的治疗目标，既可以通过显示新型“抗抑郁药”的疗效，也可以通过对生物标志物的分析来进一步提高我们对治疗的认识。单相抑郁症的病理生理学。

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