Minocycline and Celecoxib as Adjunctive Treatments of Bipolar Depression: A Factorial Design Randomised Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 265
- 试验地点
- 4
- 主要终点
- Hamilton Depression Scale scores
研究概览
简要总结
Bipolar disorder is a leading cause of disability worldwide. A high proportion of patients with bipolar disorder experience persistent depressive symptoms that do not respond to standard drug treatments. Recent evidence has suggested that anti-inflammatory treatment may reduce depressive symptoms. Minocycline is a tetracycline antibiotic with good central nervous system (CNS) penetration that has been suggested to be effective as an adjunct drug in improving depressive symptoms. Celecoxib, a selective cyclooxygenase 2 (COX-2) inhibitor, has also shown promising results in the treatment of depressive symptoms. In this factorial design, double blind, randomised controlled trial the investigators will determine the efficacy of minocycline and/or celecoxib as an adjunct to treatment as usual (TAU) in patients experiencing a depressive phase of bipolar I or II disorder. The investigators hypothesise that augmentation with minocycline and/or celecoxib will lead to an improvement in depressive symptoms in participants in comparison with placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18-65 years;
- •Diagnostic and Statistical Manual-5 (DSM 5) diagnosis of bipolar I or II disorder and current major depressive disorder;
- •Experiencing current depressive symptoms for at least 4 weeks (HAMD-17 score ≥18);
- •Competent and willing to give informed consent;
- •Taking the current medication for a minimum of 4 week prior to baseline;
- •Able to take oral medication;
- •If female, willing to use adequate contraceptive precautions and to have monthly pregnancy tests.
排除标准
- •Relevant medical illness (HIV, renal, hepatic, cardiac, serious dermatological disorders such as exfoliative dermatitis, systemic lupus erythematosis);
- •Prior history of intolerance to any of the tetracyclines or NSAIDs;
- •Concomitant penicillin therapy;
- •Concomitant anticoagulant therapy;
- •Presence of a seizure disorder;
- •Currently taking other antibiotics, other NSAIDs, acetazolamide, or methotrexate;
- •Any change of psychotropic medications within the previous 4 weeks;
- •Diagnosis of substance abuse (except nicotine or caffeine) or dependence within the last 3 months according to DSM-5 criteria;
- •Pregnant or breast-feeding;
- •Presence of primary psychotic disorder;
- •Serious risk of suicide;
- •Current three or more manic/hypomanic symptoms.
研究组 & 干预措施
Minocycline with TAU
干预措施: Minocycline (Drug)
Celecoxib with TAU
干预措施: Celecoxib (Drug)
Minocycline and celecoxib with TAU
干预措施: Minocycline (Drug)
Minocycline and celecoxib with TAU
干预措施: Celecoxib (Drug)
Placebo with TAU
干预措施: Placebo (Drug)
结局指标
主要结局
Hamilton Depression Scale scores
时间窗: 12 weeks
次要结局
未报告次要终点