EUCTR2015-003413-26-GB进行中（未招募）1 期
nderstanding the molecular basis for the use of adjunctive anti-inflammatory treatment in treatment resistant depression: a stratified, randomised, placebo-controlled, experimental medicine study using minocycline. - Minocycline and Depression (MINDEP) study
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 44
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Be aged 25-60
- •2.Have a current DSM-IV diagnosis of nonpsychotic major depressive disorder, confirmed by the Mini International Neuropsychiatric Interview (MINI);
- •3.Be non-responders to the current antidepressant taken at therapeutic doses for at least 6 weeks, as indicated by a current score of at least 14 on the 17-item Hamilton Depression Rating Scale (HAMD);
- •4.Be tolerant to the current antidepressant, and accepting augmentation with minocycline;
- •5.Have CRP levels = 1 mg/L, indicative of mild-moderate inflammation;
- •6.Have the ability to understand and sign a written informed consent form prior to participation in any screening procedures and a willingness to comply with all trial requirements.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 44
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •1.have active suicidal ideation of significant concern to require intensive monitoring by secondary psychiatry services;
- •2.have a primary diagnosis of bipolar disorder, obsessive-compulsive disorder, eating disorder, post-traumatic stress disorder, or substance/alcohol misuse disorder;
- •3.are taking warfarin;
- •4.have received tetracycline within the previous 2 months, or have a history of sensitivity or intolerance to this class of drugs;
- •5.have an acute infection; or have an autoimmune or inflammatory disorder, because of both the rare but described association between minocycline and systemic lupus erythematosus, and the potential confounder effects of these conditions on immune biomarkers.
- •6.have hepatic or renal failure
- •7.take any other psychotropic medications other than their current antidepressant that has not been approved by a study investigator prior to enrolment
- •8.Refuse that we contact their General Practitioner (GP) to inform them about their participation in the study.
- •9.(Females) Have a positive pregnancy test before starting the study/are unwilling to take a pregnancy test and are unwilling to agree to use an acceptable form of contraceptive throughout the study period (e.g. condoms, IUD/IUS, injection, patch, ring). Female participants who use combined oral contraceptives as their main form of birth control will need to use an additional barrier method for the duration of treatment and for 7 days following completion of treatment.
- •10.Breastfeeding (females)
- •11.Are currently participating in a clinical trial of an investigational medical product (CTIMP). For individuals who have been recently on CTIMP clinical trials, we will decide on case by case basis if they could be included in the trial according to the type of trial they have been involved in.
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