NCT00300313已完成不适用
PTSD Prevention Using Escitalopram
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 450
- 试验地点
- 5
- 主要终点
- CAPS
研究概览
简要总结
Assessing the efficacy of escitalopram in preventing the development of PTSD, or or reducing its severeness, after exposure to a traumatic event.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient is able to read and understand the Patient Informed Consent.
- •The patient has signed the Patient Informed Consent.
- •The patient has sufficient knowledge of Hebrew in order to understand the study procedure and instruments
- •The patient is male or female aged between 18 and 65 years (extremes included).
- •The patient underwent a traumatic event, such as vehicle or other accident, terror attack, physical or sexual assault within the last 3 weeks, and no more than 4 weeks ago.
- •The patient meets either of the following criteria:
- •Full DSM-IV criteria for ASD
- •Intrusion and hyperarousal criteria only
排除标准
- •The patient refuses having any medication therapy. This patient will be referred to another treatment outside the study frame.
- •The patient has a serious physical injury at inclusion, in which his Abbreviated Injury Scale (AIS) score, for at least one of his body regions, is 3 or more, or that according to the judgment of the clinician his injury sequelae would interfere with the study treatment.
- •The patient uses concomitant medications not allowed in the study:
- •Antidepressants, including MAOI, RIMA within the last 3 weeks prior to screening.
- •Mood stabilizers within the last 3 weeks prior to screening.
- •Antipsychotic medications within the last 3 weeks prior to screening.
- •Anxiolytics 2 weeks in a row before randomization. Patient can participate in the study if did not take the medications for 3 days over the two weeks before randomization. Except for oxazepam 10-20 mg/day no more than 7 days in a raw.
- •Serotonergic agonists (e.g. triptans) within the last 2 weeks prior to screening.
- •Prophylactic treatment with any anticonvulsant drug.
- •Herbal remedies that are psychoactive (e.g. St John's Wort, Kava kava, valerian, gingko biloba) within the last 3 weeks prior to screening.
- •The patient meets lifetime DSM-IV-TR criteria for:
- •Mania or Bipolar disorder
- •Schizophrenia
- •Any personality disorder judged by the investigator to jeopardize the evaluation of the treatment.
- •Mental retardation or pervasive disorder
- •Cognitive disorder (inc. dementia)
- •The patient has or has had alcohol or drug abuse related disorders in the last year prior to the screening visit.
- •The patient has, in the investigator's opinion, significant suicide risk and/or a score of ≥ 5 on question 10 in the MADRS scale.
- •The patient has a history of severe suicide attempt.
- •The patient requires ElectroConvulsive Therapy (ECT) or has received ECT within the last year prior to the screening visit.
- •The patient is currently serving in the Israeli security forces.
- •The patient has a history of drug allergy or hypersensitivity, or known hypersensitivity to escitalopram or citalopram.
- •The patient has an illness and/or serious sequelae thereof, severe enough according to the clinician judgment, to prevent his participation in the study, including liver or renal insufficiency; cardiovascular, pulmonary, gastrointestinal, endocrine (inc. uncontrolled thyroid), neurological (inc. epilepsy), infectious, neoplastic, or metabolic disturbances
- •The patient is pregnant or breast-feeding.
- •The patient, if woman of childbearing potential, is not using adequate contraception (adequate contraception is defined as sexual abstinence, oral/systemic contraception, surgical sterilisation, intrauterine device, diaphragm in combination with spermicide, or condom for male partner in combination with spermicide).
- •The patient, in the opinion of the investigator, is unlikely to comply with the clinical study protocol.
- •The patient has previously participated in the current study or in any other study within the last 30 days.
- •The patient has familial relationships with the investigator.
研究组 & 干预措施
1
Active Comparator
干预措施: Escitalopram (Drug)
2
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
CAPS
时间窗: 1-year follow-up
次要结局
未报告次要终点
研究者
Prof. Joseph Zohar
Prof. Joseph Zohar
Sheba Medical Center
研究点 (5)
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