NCT01492699已完成不适用
Single Site, Open Label Pilot Study of PRX-03140 to Assess Safety for Use in Adult Subjects With Post Traumatic Stress Disorder.
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
- 7
- 试验地点
- 1
- 主要终点
- Change in adverse events from baseline
研究概览
简要总结
This is a clinical study for adult subjects with Post Traumatic Stress Disorder.
详细描述
Open label clinical study to evaluate the efficacy of PRX-03140 in reducing PTSD symptoms
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects between ages 18-55
- •The subject has signed and dated the written informed consent to participate in the study
- •The subject is able to understand and comply with written and verbal protocol requirements, instructions, and protocol-stated restrictions
- •The subject meets criteria for PTSD as defined by the DSM-IV-TR
- •Stable use of clinically prescribed medications
- •Subject able to complete baseline, 4 weeks, and 12 week psychological and cognitive evaluation
- •Female subjects - not surgically sterile (hysterectomy, bilateral oophorectomy, or bilateral tubal ligation) for at least 6 months or at least 2 years postmenopausal - must agree to utilize one of the following forms of contraception, if sexually active with a male partner, from screening through completion of the study. Approved forms of contraception are abstinence, hormonal (oral, implant, transdermal, vaginal, or injection) in use at least 3 consecutive months prior to the first dose of study medication, double barrier (condom with spermicide; diaphragm with spermicide), intrauterine device (IUD), or vasectomized partner (6 months minimum since vasectomy).
排除标准
- •Actively alcohol or drug dependent as defined by DSM-IV-TR Criteria
- •Patient actively suicidal within last 12-months or with current suicidal ideation
- •History of schizophrenia, bipolar disorder, attention deficit hyperactivity disorder, learning disability, stroke, multiple sclerosis or seizure disorder by interview
- •Participation in a clinical drug research study within the past 30 days
- •Subject currently taking any SSRI or anti-depressant medication.
- •Pregnant or breastfeeding females
- •Subjects will be excluded based on lab values, ECG findings, or physical findings that the Investigators deems exclusionary.
研究组 & 干预措施
PRX-03140
Experimental
PRX-03140 for the treatment of PTSD
干预措施: PRX-03140 (Drug)
结局指标
主要结局
Change in adverse events from baseline
时间窗: weekly for 4 weeks then every 4 weeks until week 14
adverse events will be evaluated at every visit
次要结局
- Change from baseline in PTSD and mood related symptoms(weekly for 4 weeks then every 4 weeks until week 14)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
A Novel Posttraumatic Stress Disorder Treatment for Veterans With Moral InjuryMoral InjuryNCT03764033VA Office of Research and Development100
已完成
不适用
Primary Care Intervention for PTSD in EthiopiaPTSDNCT04385498University of California, Los Angeles14
招募中
不适用
A Pilot Study of Trauma-Focused Cognitive-Behavioral Therapy for Treatment of Post-traumatic Stress in Adults.Post Traumatic Stress DisorderComplex Post-Traumatic Stress DisorderNCT06516874University of Talca13
已完成
3 期
Aripiprazole in the Treatment of Post-Traumatic Stress Disorder SymptomsPosttraumatic Stress DisorderNCT00440713Federal University of São Paulo40
撤回
4 期
Trial of Hydrocortisone for Post-Traumatic Stress Disorder (PTSD)Post-traumatic Stress DisorderNCT00706173University of California, San Diego