2024-511042-39-00招募中2 期
REVERSE: a randomized controlled trial (RCT) to ameliorate treatment-resistant Post Traumatic Stress Disorder (PTSD) with Glucocorticoid Receptor (GR) antagonism
Amsterdam UMC1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年4月19日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To investigate whether mifepristone (7-day, 1200 mg/day) is more efficacious than placebo in reducing PTSD symptom severity 4 weeks after the start of the intervention, as measured with the monthly version of the CAPS-5 (Clinician Administered PTSD scale) in patients with treatment-resistant PTSD.
研究概览
简要总结
To investigate whether mifepristone (7-day, 1200 mg/day) is more efficacious than placebo in reducing PTSD symptom severity (Clinician Administered PTSD scale, CAPS-5) in patients with treatment-resistant PTSD in a randomized controlled trial.
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Mastery of Dutch language
- •Age of ≥ 18 years of age and able to give written consent
- •Participant agrees to be randomized
- •DSM-5 diagnosis of PTSD, confirmed with clinical interview (CAPS-5)
- •Treatment-resistant PTSD: CAPS-5 score ≥ 30 and nonresponse to two evidence-based treatments for PTSD recommended by a recent clinical practice guidelines delivered with fidelity and at an effective dose, at least one of which is a full course of trauma-focused psychotherapy.
排除标准
- •Bipolar disorder, psychotic disorder, or current alcohol/drug dependence that requires clinical attention.
- •Female participant being a WOCBP and who does not want to use a non-hormonal contraceptive method (condom) 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 medications containing: CYP3A4-inhibitors/inductors/substrates, CYP2C8/9 substrates, P-gp and BCRP transported drugs, glucocorticoid antagonists, systemic corticosteroids or unstable drug dosages (tapering/titrating antidepressants).
结局指标
主要结局
To investigate whether mifepristone (7-day, 1200 mg/day) is more efficacious than placebo in reducing PTSD symptom severity 4 weeks after the start of the intervention, as measured with the monthly version of the CAPS-5 (Clinician Administered PTSD scale) in patients with treatment-resistant PTSD.
To investigate whether mifepristone (7-day, 1200 mg/day) is more efficacious than placebo in reducing PTSD symptom severity 4 weeks after the start of the intervention, as measured with the monthly version of the CAPS-5 (Clinician Administered PTSD scale) in patients with treatment-resistant PTSD.
次要结局
- PTSD symptom severity as measured with the weekly version of the PCL-5, from baseline till 12 weeks after the start of the intervention (T3).
- Long-term PTSD symptom severity as measured with the CAPS-5, at 12 weeks after the start of the intervention (T3).
- Loss of diagnosis (score of <26 and absence of PTSD criteria with CAPS-5), 4 weeks after the start of the intervention.
- Treatment response (minimum decrease of 10 point on the PCL-5 and CAPS-5 scores) at 1, 4 and 12 weeks after the start of the intervention.
- Other clinical outcomes 1, 4, and 12 weeks after the start the intervention: o disability (WHO Disability Schedule 2.0; WHO-DAS II), o sleep (Insomnia Severity Index; ISI), o subjective stress (Perceived Stress Scale; PSS), o anxiety symptoms (Beck Anxiety Inventory; BAI), o depressive symptoms (IDS-SR), o suicidal ideation and behaviour (Columbia-Suicide Severity Rating Scale).
研究者
Felix Linsen
Scientific
Amsterdam UMC
研究点 (1)
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