Minocycline as an adjunct for treatment-resistant depressive symptoms: study protocol for a pilot randomised controlled trial

• Published in: Current controlled trials in cardiovascular medicine Vol. 16; no. 1; p. 410
• Main Authors: Husain, Muhammad I, Chaudhry, Imran B, Rahman, Raza R, Hamirani, Munir M, Qurashi, Inti, Khoso, Ameer B, Deakin, John F W, Husain, Nusrat, Young, Allan H
• Format: Journal Article
• Language: English
• Published: England BioMed Central Ltd 15.09.2015; BioMed Central
• Subjects: Anti-Inflammatory Agents - adverse effects; Anti-Inflammatory Agents - therapeutic use; Anti-inflammatory drugs; Antibiotics; Antidepressants; Antidepressive Agents - adverse effects; Antidepressive Agents - therapeutic use; Anxiety; Care and treatment; Clinical trials; Complications and side effects; Depressive Disorder, Major - diagnosis; Depressive Disorder, Major - drug therapy; Depressive Disorder, Major - psychology; Depressive Disorder, Treatment-Resistant - diagnosis; Depressive Disorder, Treatment-Resistant - drug therapy; Depressive Disorder, Treatment-Resistant - psychology; Development and progression; Dosage and administration; Double-Blind Method; Drug therapy; Drug Therapy, Combination; FDA approval; Humans; Illnesses; Informed consent; Medical research; Medicine, Experimental; Mental depression; Minocycline; Minocycline - adverse effects; Minocycline - therapeutic use; Pakistan; Patient outcomes; Patients; Pilot Projects; Psychiatric Status Rating Scales; Psychosis; Psychotropic drugs; Remission (Medicine); Research Design; Severity of Illness Index; Study Protocol; Surveys and Questionnaires; Teams; Time Factors; Treatment Outcome; Pakistan; Karachi Pakistan
• ISSN: 1745-6215; 1745-6215
• DOI: 10.1186/s13063-015-0933-5

Depression is one of the leading causes of disability worldwide. A high proportion of patients do not respond to standard drug treatments. Recent evidence has suggested that anti-inflammatory treatment may have beneficial effects in major depression. Minocycline is a tetracycline antibiotic with good CNS penetration that exerts effects on multiple interacting symptoms implicated in the pathophysiology of mood disorders. Open-label studies have suggested that minocycline is effective as an adjunct drug in improving depressive symptoms. This is a multi-centre, 3-month, double-blind, placebo-controlled, pilot trial of minocycline added to treatment as usual for patients suffering from DSM-IV major depressive disorder. This will be a double-blind, randomised, controlled, two parallel-arm study with 20 participants in each arm, giving a total of 40 participants. There will be a screening visit, a randomization visit and four follow-up visits. Clinical assessments using the Hamilton Depression Rating Scale (HAM-D), Clinical Global Impression scale (CGI), Patient Health Questionnaire-9 (PHQ -9) and the Generalised Anxiety Disorder scale (GAD-7) will be carried out at every visit. Side effects checklists will also be undertaken at each visit. Biomarkers (inflammatory cytokines and CRP) will be measured at baseline and at the end of the treatment phase. Minocycline will be started at 100 mg once daily (OD) and will be increased to 200 mg at two weeks. Anti-inflammatory treatments have been shown to have some beneficial effects in the treatment of major depressive disorder. The aim of this pilot randomised controlled trial is to establish the degree of improvement in depressive symptoms with the addition of minocycline to treatment as usual. ClinicalTrials.gov NCT02263872 registered 10 October 2014.