EUCTR2012-001288-58-NL进行中（未招募）不适用
Boosting oxytocin after trauma: The effects of intranasal oxytocin administration on emotional and motivational brain processes in PTSD - The effect of oxytocin in PTSD
Academic Medical Center0 个研究点开始时间: 2012年3月27日最近更新:
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试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •Age 18 – 65 years
- •Capable to read and comprehend the Dutch language
- •Eligibility for MRI (i.e. no metals, pacemakers or claustrophobia)
- •Exposed to a potentially traumatic event, according to PTSD A1 criterion in the DSM-IV (minimal 1 month ago), quantified as a score of 1 or higher on the Life Events Checklist (LEC).
- •PTSD patients:
- •Current PTSD diagnosis
- •CAPS score = 45
- •Traumatized healthy controls:
- •CAPS-score < 15
- •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 80
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Any severe or chronic systemic disease
- •Current psychotic, bipolar, substance-related, severe personality disorder, or mental retardation
- •Current severe depressive disorder
- •Prominent current suicidal risk or homicidal ideation
- •Severe cognitive impairment or a history of organic mental disorder
- •History of neurological disorders (e.g., traumatic brain injury, seizure history)
- •Reports of ongoing traumatization (e.g., in case of partner violence as index adult trauma)
- •Evidence of clinically significant and unstable medical conditions in which OT administration is contra-indicative such as cardiovascular, gastro-intestinal, pulmonary, severe renal, endocrine or hematological disorders, glaucoma, history of epilepsy, or a stroke or myocardial infarction within the past year
- •Use of certain medication: prostaglandins, certain anti-migraine medications (ergot alkaloids), ß-adrenergic receptor-blocking agents, systemic glucocorticoids and psychopharmacological medication.
- •Sensitivity or allergy for OT or its components (e.g. methylhydroxybenzoate and propylhydroxybenzoate)
- •Female participants: pregnancy and breast feeding (NB. Female participants with childbearing potential must have a negative pregnancy test).
- •Traumatized healthy controls only:
- •(lifetime history of) PTSD diagnosis, major depressive disorder.
- •current DSM-IV axis 1 disorder
研究者
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