NL-OMON39817已完成2 期
Boosting oxytocin after trauma: The effects of intranasal oxytocin administration on emotional and motivational brain processes in PTSD - The effect of oxytocin in PTSD
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 83
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99(—)
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
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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