Minocycline as a new treatment for depression

Category Primary study
Registry of TrialsANZCTR
Year 2012
INTERVENTION: 200 mg/day of oral (1 tablet bidaily) adjunctive minocycline will be trialled against placebo for 12 weeks to determine the efficacy of minocycline for the treatment of unipolar depression. CONDITION: Unipolar depression PRIMARY OUTCOME: Change in depressive symptoms based on the Montgomery‐Asberg Depression Rating Scale (MADRS) SECONDARY OUTCOME: Analysis of inflammatory and oxidative biomarkers in peripheral blood samples (pending further funding) Change in Clincial Global Impressions ‐ Severity Scale (CGI‐S) Change in Clinical Global Impressions ‐ Improvement Scale (CGI‐I) Change in anxiety symptoms based on the Hamilton Anxeity Rating Scale (HAM‐A) Change in functioning based on the Range of Impaired Functioning Tool (LIFE/RIFT) Change in functioning based on the Social and Occupational Functioning Assessment Scale (SOFAS) Change in quality of lifre based on the Quality of Life Enjoyment and Satisfaction Questionnaire (Q‐LES‐Q) Changes in MADRS, CGI‐I, CGI‐S, HAM‐A, SOFAS, LIFE/RIFT and Q‐LES‐Q following discontinuation of trial medication. Investigation of safety and tolerability using adverse events (for example, changes in skin pigmentation) INCLUSION CRITERIA: ‐Aged 18 or over ‐Capacity to consent to the study and to follow its instructions and procedures ���Fulfil the DSM‐IV‐TR diagnostic criteria for major depressive disorder, single episode or recurrent, as well as scoring 20 or over on the MADRS, at the baseline visit ‐Participants on antidepressant therapy need to have been on the same treatment for at least two weeks prior to randomisation ‐Utilising effective contraception (other than the contraceptive pill due to drug interactions) if female of child‐bearing age and sexually active
Epistemonikos ID: 621e4e9c609d3f5d28c3245cf3c40be1b4f6f971
First added on: Aug 25, 2024