Minocycline and celecoxib as adjunctive treatments for bipolar depression: a study protocol for a multicenter factorial design randomized controlled trial
Authors Husain MI, Chaudhry IB, Hamirani MM, Minhas FA, Kazmi A, Hodsoll J, Haddad P, Deakin JFW, Husain N, Young AH
Received 15 June 2016
Accepted for publication 28 September 2016
Published 19 December 2016 Volume 2017:13 Pages 1—8
Checked for plagiarism Yes
Review by Single anonymous peer review
Peer reviewer comments 3
Editor who approved publication: Dr Roger Pinder
Muhammad I Husain,1 Imran B Chaudhry,2 Munir M Hamirani,3 Fareed A Minhas,4 Ajmal Kazmi,5 John Hodsoll,6 Peter M Haddad,7 John FW Deakin,7 Nusrat Husain,7 Allan H Young8
1Camden and Islington NHS Foundation Trust, St Pancras Hospital, London, UK; 2Pakistan Institute of Learning and Living, 3Department of Psychiatry, Abbasi Shaheed Hospital, Karachi, 4Institute of Psychiatry, Rawalpindi Medical College, Rawalpindi, 5Department of Psychiatry, Karwan-e-Hayat Hospital, Karachi, Pakistan; 6Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King’s College London, London; 7Division of Psychology and Mental Health, University of Manchester, Manchester, 8Centre for Affective Disorders, Institute of Psychiatry, Psychology and Neuroscience, King’s College London, London, UK
Background: Evidence suggests that the use of anti-inflammatory agents may improve depressive symptoms in patients with bipolar affective disorder. However, there are few well-designed clinical trials demonstrating the efficacy of these newer treatment strategies.
Patients and methods: This is a multicenter, 3-month, randomized, placebo-controlled, double-blind, factorial design trial of minocycline and/or celecoxib added to TAU for the treatment of depressive symptoms in patients experiencing a DSM-5 bipolar I or II disorder and a current major depressive episode. A total of 240 participants will undergo screening and randomization followed by four assessment visits. The primary outcome measure will be mean change from baseline to week 12 on the Hamilton Depression Scale scores. Clinical assessments using the Clinical Global Impression scale, Patient Health Questionnaire-9, and the Generalized Anxiety Disorder 7-item scale will be carried out at every visit as secondary outcomes. Side-effect checklists will be used to monitor the adverse events at each visit. Complete blood count and plasma C-reactive protein will be measured at baseline and at the end of the treatment. Minocycline will be started at 100 mg once daily and increased to 200 mg at 2 weeks. Celecoxib will be started at 200 mg once daily and increased to 400 mg at 2 weeks.
Discussion: Anti-inflammatory agents have been shown to be potentially efficacious in the treatment of depressive symptoms. The aim of this study is to determine whether the addition of minocycline and/or celecoxib to TAU improves depressive symptoms in patients with bipolar affective disorder.
Keywords: bipolar disorder, depression, inflammation, anti-inflammatory, minocycline, celecoxib
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