DRKS00009444已完成2 期
A Double-blind, Placebo-controlled, Randomized, Multicenter Proof-of-principle Trial of Adjunctive Minocycline for Patients With Treatment-Resitant Unipolar Major Depressive Disorder (MDD) - Mino-TRD
Charité - Universitätsmedizin Berlin, Sponsorvertretung: Frau Prof. Dr. Dipl.-Psych. Isabella Heuser0 个研究点目标入组 173 人开始时间: 2015年12月4日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 173
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 75 Years（—）
- 性别
- All
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-5.
- •HAMD-17 score of at least 16 points at baseline and a
- •CGI-S score of at least 4.
- •AD-ST must have been administered at a sufficient dose for at least 6 weeks prior to baseline without a sufficient response. Simultanous Treatment with other ADs or Quetiapin/Aripirazol, administered in antidepresssive indication, is possible. All ADs must have been administered for at least 6 weeks in the current episode and at a
- •stable regimen for at least 14 days prior to baseline .
排除标准
- •prevalence of neurodegenerative disorder
- •prevalence of a neurological disorder that caused depression
- •prevalence of any severe, unstable general medical condition, including chronic inflammatory disease such as rheumatoid arthritis or inflammatory bowel disease
- •Depressive symptoms are based on any other axis I disorder
- •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, liver or kidney dysfunction
- •history of autoimmune disease (allowed: Hashimotos thyroiditis)
- •clinically significant laboratory abnormalities
- •current medication with anti-inflammatory substances (NSAIDs, corticosteroids) or retinoids
- •any adverse effect as a consequence of a former tetracycline intake inclusive any hypersensitivity reactions due to tetracycline or any known tetracycline incompatibility
- •Involuntary commitment
- •Acute suicidality tendency or suicide attempts during the current episode or in the last 5 years
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