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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While current pharmacotherapies are efficacious, there remain a clear shortfall between symptom remission and functionalrecovery. With the explosion in our understanding of the biology of these disorders, the time is ripe for the investigation ofnovel 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 neuroprotectiveproperties that make it a viable target to explore as a new therapy. This double blind, randomised, placebo controlled adjunctivetrial will investigate the benefits of 200 mg/day of minocycline treatment, in addition to any usual treatment, as an adjunctivetreatment for moderate-severe major depressive disorder. Sixty adults are being randomised to 12 weeks of treatment (witha 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 FunctioningAssessment Scale (SOFAS), Clinical Global Impressions (CGI), Hamilton Rating Scale for Anxiety (HAM-A), Patient GlobalImpression (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 newtreatment targets, both by showing efficacy with a new class of ‘antidepressant’ but also through the analysis of biomarkersthat may further inform our understanding of the pathophysiology of unipolar depression.
Abstract
While current pharmacotherapies are efficacious, there remain a clear shortfall between symptom remission and functionalrecovery. With the explosion in our understanding of the biology of these disorders, the time is ripe for the investigation ofnovel 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 neuroprotectiveproperties that make it a viable target to explore as a new therapy. This double blind, randomised, placebo controlled adjunctivetrial will investigate the benefits of 200 mg/day of minocycline treatment, in addition to any usual treatment, as an adjunctivetreatment for moderate-severe major depressive disorder. Sixty adults are being randomised to 12 weeks of treatment (witha 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 FunctioningAssessment Scale (SOFAS), Clinical Global Impressions (CGI), Hamilton Rating Scale for Anxiety (HAM-A), Patient GlobalImpression (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 newtreatment targets, both by showing efficacy with a new class of ‘antidepressant’ but also through the analysis of biomarkersthat may further inform our understanding of the pathophysiology of unipolar depression.
참고문헌 (43)
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