EUCTR2012-002954-21-BE进行中（未招募）1 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
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
- 80
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
- •- 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
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 64
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 16
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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The Effect of Minocycline on Relapse After Successful Intravenous Ketamine/Minocycline-induced Symptoms Response in Subjects with DepressioDepressive DisorderMedDRA version: 17.0Level: PTClassification code 10004940Term: Bipolar II disorderSystem Organ Class: 10037175 - Psychiatric disordersMedDRA version: 17.0Level: PTClassification code 10057840Term: Major depressionSystem Organ Class: 10037175 - Psychiatric disordersEUCTR2012-002954-21-NLJanssen-Cilag International N.V.80
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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 responseBipolar Depression type II: depressive disordersMajor Depressiv Disorder10027946NL-OMON40601Janssen-Cilag20
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