NL-OMON52772招募中3 期
Targeted glucocorticoid administration to improve safety learning in PTSD patients with HPA axis dysregulation - CovoS
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 190
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
- •Patient group:
- •Participants with PTSD (n = 160) will be recruited (1) at collaborating
- •treatment centres, before the start of their trauma-focused therapy treatment,
- •when they have at least a suspected PTSD diagnosis with an indication for
- •trauma-focused therapy, or (2) independently from treatment centres, when they
- •declare to have received a PTSD diagnosis by a doctor or specialist and
- •currently experience considerable PTSD symptoms; these participants will be
- •screened with a PTSD diagnostic interview (CAPS-5) to confirm current PTSD
- •diagnosis (otherwise exclusion). Patients must be aged 18-64. If applicable,
- •the expected waiting time until treatment is sufficient for participation, at
- •least for part A of the study, with minimal overlap with treatment beng allowed
- •(as specified in research protocol). Progression of patients into substudy B
- •follows based on additional screening criteria, interest and feasibility.
- •Control group:
- •Healthy, non-trauma exposed control participants (n = 30) will be recruited
- •from the general population in and around Nijmegen. Control participants only
- •complete assessments from substudy A. Control participants must be aged 18-64
- •years. Inclusion criteria are no history of psychiatric disorders, and no
- •history of childhood maltreatment. Hence, this group will reflect a healthy,
- •non-trauma exposed control group, Control participants will be selected based
- •on age, gender and education, with the aim to match the distributions of these
- •relevant basic demographic variables to the (expected) distributions of the
- •included patient group.
排除标准
- •Patient group:
- •Current episode of psychotic or manic symptoms.
- •Daily intake of benzodiazepines, or otherwise irregular intake of
- •benzodiazepines (*when needed*) but unable to withhold intake from the day
- •prior to each test session until the end of the each test session. An exception
- •is made for low doses of short-acting benzodiazepines that are prescribed for
- •insomnia (i.e. as sleep medication).
- •A relevant neurological disorder (e.g., stroke, epilepsy, Multiple Sclerosis)
- •or severe physical disorder which is likely to impact assessment procedures or
- •Reports to be unable or unwilling to withhold recreational drug use and limit
- •alcohol use from the day prior to each test session until the end of the each
- •test session.
- •General learning disability, or known to have intelligence Quotient (IQ) <
- •Body Mass Index (BMI) of >35.
- •If relevant, endocrine disorder and/or current or recent endocrine treatment
- •(<1 month ago; for e.g., phechromocytoma, hyperthyroidism, Cushing*s
- •Current or recent regular use of corticosteroids (<1 month ago).
- •For women: Pregnancy.
- •Reports hypersensitivity to hydrocortisone or any of the tablet*s auxiliary
- •(Only for part B) contraindications for MRI scanning (e.g., pacemaker,
- •implanted metal parts, metal in or around the body, deep brain stimulation,
- •severe claustrophobia).
- •Note: based on the exclusion criteria above, it may be decided by the research
- •team that a participant should only participate in part A of the study, but
- •will be excluded from part B of the study
- •Control group:
- •History of childhood maltreatment
- •Current or past psychiatric disorder
- •Use of psychotropic medication
- •Relevant neurological disorder (e.g., stroke, epilepsy, Multiple Sclerosis)
- •or severe physical disorder which is likely to impact assessment procedures or
- •Reports to be unable or unwilling to withhold recreational drug use and limit
- •alcohol use from the day prior to each test session until the end of the each
- •test session.
- •General learning disability, or known to have intelligence Quotient (IQ) <
- •Body Mass Index (BMI) of >35.
- •If relevant, endocrine disorder and/or current or recent endocrine treatment
- •(<1 month ago; for e.g., phechromocytoma, hyperthyroidism, Cushing*s
- •Current or recent regular use of corticosteroids (<1 month ago).
- •For women: Pregnancy.
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