Abstract
BackgroundAvailable evidence suggests that adjunctive treatment with immunomodulatory medications may be effective in the treatment of major depressive disorder (MDD). A pilot trial of the tetracycline minocycline as adjunctive treatment in treatment-resistant depression (TRD), produced promising results, however, a larger scale trial is needed to confirm the antidepressant actions of this drug.MethodsThis is a 12-week double blind, placebo-controlled, randomized trial of minocycline as an add-on to standard antidepressants for adults (age > 18) with DSM-5 major depressive episode, who have failed to respond to at least two adequate trials of antidepressant treatment. It is a parallel-arm study with 50 participants in each group. The primary outcome measure is change in 17-item Hamilton Depression Rating Scale (HRSD-17) total scores from baseline to week 12. Secondary measures include the Clinical Global Impression (CGI) scale, World Health Organization Quality of Life Short Version (WHOQOL-BREF) and the Generalized Anxiety Disorder scale (GAD-7). Peripheral inflammatory biomarkers will be collected at baseline, week 6 and 12.DiscussionIf minocycline is well tolerated and effective in reducing depressive symptoms in patients with TRD, it would warrant genuine consideration as a treatment option for TRD. Additionally, if results demonstrate that minocycline has antidepressant properties, and that changes in inflammatory status are associated with its antidepressant action, it will inform the development of individualized treatment for a subset of patients with MDD.Trial registrationClinicaltrials.gov identifier: NCT03947827. Registered 13th May, 2019.
Highlights
Available evidence suggests that adjunctive treatment with immunomodulatory medications may be effective in the treatment of major depressive disorder (MDD)
The current study aims is to examine whether minocycline added to standard antidepressants for 3 months in patients with treatment-resistant depression (TRD) leads to a reduction in depressive symptoms as measured by the 17-item Hamilton Rating Scale for Depression (HRSD-17) compared with placebo added to antidepressants
We expect that minocycline will significantly reduce the severity of depressive symptoms compared to the placebo group
Summary
This study is a 12 week, double blind, placebo-controlled, randomized trial of minocycline added to standard oral antidepressants for patients suffering from a Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) [26] major depressive episode, who have failed to respond to adequate dose-duration trials of at least two antidepressants. It will be a two parallel-arm study with 50 participants in each arm, giving a total of 100 participants. Assessment Medical Confirmation of Eligibility, SCID-5 Clinical Bloodwork Randomization HRSD-17 CGI GAD-7 WHOQOL-BREF Minocycline dispensed TAU/Concomitant medication Adverse Event Checks Physical health measures Biomarkers (CRP, cytokines) Telephone contact. Subgroup analysis will be carried out with respect to age and gender by adding a treatment with covariate interaction into the primary analysis model
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