EUCTR2012-003072-39-NL进行中（未招募）不适用
Oxytocin in PTSD: effectiveness as addition to Narrative Exposure Therapy - Oxytocin in PTSD: Effectiveness in addition to NET (OPEN)
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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
- •- Patients with a diagnosis of chronic PTSD (> 3 months)
- •-CAPS score of 50
- •-Age 18-65 years
- •-Written informed consent
- •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 24
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •-Suicidal risk.
- •- Presence of any of the following DSM IV diagnoses, at present or in the past: psychotic disorder incl. schizophrenia, a bipolar disorder, or excessive substance related or eating disorder over the past 6 months.
- •- Female patients being pregnant (NB. female patients with childbearing potential must have a negative pregnancy test each month).
- •- Female patients with an active pregnancy wish.
- •- Female patients giving lactation to their child.
- •- Diagnosis of current severe depressive disorder (with psychotic features and/or high suicidal intent).
- •- An organic disorder/cognitive impairment.
- •- Patients using psychotropic medications will be required to have been on a stable dose for at least 2 months before their pre-treatment assessment (T0). Psychotropic medication already used at the pre-treatment assessment will be maintained until the post-treatment assessment. No psychotropic medication will be prescribed for participants during the study unless they develop serious depressive symptoms. A medication protocol in accordance with clinical guidelines (A.P.A., 2004; Institute of Medicine (IOM), 2008; National Institute for Clinical Excellence, 2005) will be used.
- •-Use of prostaglandins and certain anti-migraine medications (ergot alkaloids), systemic glucocorticoids and beta-blockers.
- •-Sensitivity or allergy for oxytocin or its components (e.g. methylhydroxybenzoaat en propylhydroxybenzoaat)
- •-Evidence of clinically significant and unstable medical conditions in which OT administration is contra-indicative, including cardiovascular, gastro-intestinal, pulmonary, severe renal, endocrine or hematological disorders, glaucoma, history of epilepsy, and stroke or myocardial infarction within the past year.
研究者
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