A Double-blind, Placebo-controlled, Randomized, Multicenter Proof-of-principle Trial of Adjunctive Minocycline for Patients With Unipolar Major Depressive Disorder (MDD)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 168
- 试验地点
- 8
- 主要终点
- Response as per MADRS (Montgomery-Åsberg Depression Rating Scale)
研究概览
简要总结
This study examines the antidepressant efficacy of minocycline as an adjunct to an antidepressant standard treatment (AD-ST), for patients with unipolar major depressive disorder (MDD).
详细描述
This is a double-blind, placebo-controlled, randomized, multicenter proof-of-principle trial of adjunctive minocycline for patients with unipolar major depressive disorder (MDD). The study tests the antidepressant efficacy of minocycline as an adjunct to an antidepressant standard treatment (AD-ST), for patients with unipolar major depressive disorder (MDD). The respective AD, for which non-response has been documented, must be on a stable regimen for at least 14 days prior to inclusion. AD-ST will then be continued throughout the trial. Trial medication is adjunct oral minocycline 200 mg/day or placebo. Response to treatment will be measured via the Montgomery-Asberg Depression Rating Scale (MADRS). The total study duration for each patient will be 6 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent
- •male or female
- •between age 18 and 75
- •BMI between 18 and 40 inclusive
- •Non-lactating, non-pregnant females of child-bearing potential must be willing to use an effective contraceptive method
- •All participants must fulfil diagnostic criteria of moderate or severe MDD according to the DSM-
- •HAMD-17 score of at least 16 points at baseline and a
- •CGI-S score of at least
- •AD-ST must have been administered at a sufficient dose for at least 6 weeks in the current episode and at a
- •stable regimen for at least 14 days prior to baseline.
- •Dose and duration of AD-ST must be verifiable
排除标准
- •prevalence of neurodegenerative disorder
- •prevalence of any neurological disorder that caused the depressive symptoms
- •prevalence of any severe, unstable general medical condition, including chronic inflammatory disease such as rheumatoid arthritis or inflammatory bowel disease
- •prevalence of any other psychiatric disorder that better explains the presence of depressive symptoms
- •Improvement by more than 50% in HAMD-17 score during the last 14 days prior to baseline
- •pregnant or nursing women will not be allowed.
- •substance or alcohol abuse within past 6 months or positive urine drug screening
- •abnormal thyroid function (euthyroid at presentation), liver or kidney dysfunction
- •history of autoimmune disease (except Hashimotos thyroiditis)
- •clinically significant laboratory abnormalities (outside normal ranges)
- •current medication with anti-inflammatory substances (NSAIDs, corticosteroids)
研究组 & 干预措施
Minocycline
Minocycline and standard antidepressant treatment
干预措施: Minocycline (Drug)
Placebo
Placebo and standard antidepressant treatment
干预措施: Placebo (Drug)
结局指标
主要结局
Response as per MADRS (Montgomery-Åsberg Depression Rating Scale)
时间窗: 6 weeks
次要结局
- Remission as per MADRS (Montgomery-Åsberg Depression Rating Scale)(6 weeks)
- HAM-D-17-Scale (17-item Hamilton Depression Rating Scale)(6 weeks)
- BDI-Scale (Beck Depression Inventory, Self Rating Scale)(6 weeks)
- CGI-Scale (Clinical Global Impressions Scale)(6 weeks)
- SCL-90-R (Symptom Checklist 90-R, Self Rating Scale)(6 weeks)
- Transcriptomic changes in patient-specific peripheral blood-derived monocytic cells(6 weeks)
- Protein levels of various inflammation-associated markers in patient sera(6 weeks)
研究者
Isabella Heuser
MD, PhD
Charite University, Berlin, Germany