EUCTR2020-003385-40-NL进行中（未招募）1 期
REStoring mood after Early life Trauma – Glucocorticoid Receptor (GR) blockade as disease-modifying treatment for depression with childhood trauma - RESET-medication
Amsterdam UMC, location VUmc0 个研究点目标入组 158 人开始时间: 2021年2月24日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 158
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
- •Mastery of Dutch language
- •Age of = 18 years of age and able to give written IC
- •Participant agrees to be randomized
- •Moderate to severe depression
- •Score = 26 on the Inventory of Depressive Symptoms-Self Report (IDS-SR)
- •DSM-5 diagnosis of major depression disorder (MDD), confirmed with clinical interview (MINI)
- •Moderate to severe childhood trauma (CT) before the age of 18
- •Score above validated cut-off for moderate to severe CT on one or more of the following
- •domains using the Childhood Trauma Questionnaire (CTQ):
- •? physical neglect: score = 10
- •? emotional neglect: score = 15
- •? sexual abuse: score = 8
- •? physical abuse: score = 10
- •? emotional abuse: score = 13
- •A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of
- •the following conditions applies:
- •o Is not a WOCBP
- •o Is a WOCBP and agrees to use an acceptable non-hormonal contraceptive method (e.g. condom, also if
- •hormonal contraceptive method is used) during the intervention period and up to 1 month after the
- •intervention. A WOCBP must have a negative highly sensitive pregnancy test before the first dose of the study
- •intervention.
- •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 158
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •A potential participant who meets any of the following criteria will be excluded from participation in this study:
- •Primary diagnosis of post-traumatic stress disorder (PTSD) or Acute Stress disorder (ASD)
- •Lifetime diagnosis of borderline personality disorder (BPD)
- •Current alcohol/drug dependence or other severe psychiatric comorbidity (e.g. bipolar disorder, schizophrenia) that
- •requires clinical attention.
- •Start of other forms of depression treatment in the week before or after the start of intervention.
- •Female participant being a WOCBP who do not agree to use an acceptable non-hormonal contraceptive method
- •(e.g. condom, also if hormonal contraceptive method is used) during the intervention period and up to 1 month after
- •the intervention.
- •Female participants that are pregnant or breastfeeding. Pregnancy is excluded using a negative highly sensitive
- •pregnancy test before the first dose of the study medication during the baseline visit.
- •Female participants that have a history of unexplained vaginal bleeding or endometrial changes
- •Chronic adrenal insufficiency
- •Current use of:
- •o Medications containing CYP3A4-inhibitors, as an interaction of CYP3A4-inhibitors and mifepristone leads to higher
- •mifepristone plasma levels and increases the chance of having side effects. This also includes the consumption of
- •grapefruit juice during the intervention
- •o Medications containing CYP3A4-inductors, as an interaction of CYP3A4-inductors and mifepristone leads to lower
- •mifepristone plasma levels and decreases the chance of having a beneficial effect. This also includes the consumption
- •of St John’s worth /hypericum perforatum during the intervention.
- •o Glucocorticoid antagonists within 1 week before possible start of trial treatment.
- •o Systemic corticosteroids. Topical corticosteroid treatment are acceptable, with the exception of inhaled
- •corticosteroids (inhalators).
- •Before randomization, all currently used medications will be reviewed by a pharmacologist from the hospital pharmacy to prevent toxicity or interaction with mifepristone.
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