NL-OMON40601已完成2 期
An exploratory, blinded, randomized, placebo-controlled study in subjects with depressive disorder to investigate the effect of minocycline on relapse after successful intravenous ketamine/minocycline-induced (partial) symptoms response - the effect of minocycline on relapse after ketamine/minocycline
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Diagnostic criteria for moderate to severe major depressive disorder (MDD), without mood incongruent psychotic features, or Bipolar Disorder Type II ;- Patients should have an Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) total score >= 34 at Screening and at Day 1 (predose) ;- Patients with major depressive disorder should have failed at least two adequate treatment courses (dose and duration) with antidepressant therapy, one of which is in the current episode ;- Patients should not have received electroconvulsive therapy (ECT) in the current episode but could be those for whom ECT is considered ;- Patients with bipolar depression (BPD) Type II must have been taking a stable dose of a mood-stabilizing medication (e.g., lithium, valproate, carbamazepine, lamotrigine, antipsychotic agents) for at least 4 weeks, dosed clinically to target the therapeutic range ;- Patients currently taking an antidepressant(s) must have received at least 2 weeks of stable antidepressant therapy at the time of Screening ;- Doses of current antidepressant therapies should remain the same for the duration of the study ;- Women must be postmenopausal, surgically sterile, or if heterosexually active, practicing a highly effective method of birth control ;- Men who are heterosexually active with a woman of childbearing potential must agree to use a double barrier method of birth control and to not donate sperm during the study and for 3 months after receiving the last dose of study drug
排除标准
- •- Has a current DSM-IV axis I diagnosis other than MDD or BPD Type II at screening (except for co-morbid anxiety disorders) ;- Has a diagnosis of substance abuse or dependence within 6 months prior to screening evaluation (nicotine and caffeine dependence are not exclusionary) ;- Patient is currently taking > 4 psychotropic medications at Day 1 (predose) ;- Has an autoimmune disorder such as Crohn*s disease, rheumatoid arthritis, psoriasis currently treated with/requiring treatment with immunomodulatory therapies ;- Has any significant cardiovascular, respiratory, neurologic, renal, hepatic, endocrine, immunologic diseases, glaucoma, hypothyroidism or hyperthyroidism based on screening examination ;- Has uncontrolled hypertension (diastolic blood pressure >= 90 mmHg), despite diet, exercise or a stable dose of an allowed antihypertensive treatment, at Screening or Day 1 (predose) ;- Has planned vaccination within 2 weeks prior to the first dose of study medication through 2 weeks after the last dose of study medication ;- Has an active infectious disease/current infection ;- Has known allergies, hypersensitivity, or intolerance to minocycline or ketamine or its excipients ;- Has contraindications to the use of minocycline or ketamine per local prescribing information
研究者
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