NL-OMON52484招募中2 期
REStoring mood after Early life Trauma - Glucocorticoid Receptor (GR) blockade as disease-modifying treatment for depression with childhood trauma - RESET - medication
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 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
入排标准
- 年龄范围
- 18 至 64（—）
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
- •(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.
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
- •randomization.
- •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
- •o Systemic corticosteroids. Topical corticosteroid treatment are acceptable,
- •with the exception of inhaled corticosteroids (inhalators).
- •Before randomization, all currently used medications will be reviewed to
- •prevent toxicity or interaction with mifepristone.
研究者
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