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临床试验/NL-OMON39817
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

Academisch Medisch Centrum0 个研究点目标入组 83 人开始时间: 待定最近更新:
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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