NCT01533519已完成1 期
A Dose Escalation Study of Intranasal Neuropeptide Y in PTSD
James Murrough1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2012年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Patient Rated Inventory of Side Effects (PRISE)
研究概览
简要总结
This study is designed to investigate the safety of intranasal administration of NPY using a dose escalation, randomized, double-blinded, placebo-controlled crossover design in a medication-free, symptomatic PTSD group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women, age 18-
- •Participants must have a level of understanding sufficient to agree to all tests and examinations required by the protocol and must sign a written informed consent document. We determine whether they have a sufficient understanding of the study procedures and risks by asking them to explain what's involved in the study and to give examples of study risks and benefits.
- •Participants must fulfill DSM-IV criteria for current PTSD, based on the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I) and on the Clinician-Administered PTSD Scale (CAPS).
- •CAPS score must be at least 40 (moderate PTSD severity) at screening.
排除标准
- •Current, primary Axis I disorders other than PTSD.
- •History or current bipolar disorder or primary psychotic disorders (e.g. schizophrenia, schizoaffective disorder).
- •Current diagnosis of anorexia nervosa or bulimia nervosa.
- •Women who are pregnant or are breast-feeding.
- •Drug or alcohol abuse or dependence within the preceding 3 months.
- •poorly controlled hypertension (manifest by SBP > 140 and/or DBP > 90); HR < 60 or > 100 at rest at the time of screening and confirmed immediately prior to randomization
- •Evidence of coronary artery disease as evidenced by history, abnormal ECG, typical symptoms
- •History of arrhythmia, cardiac surgery, or family history of sudden death
- •Hepatic dysfunction as defined by AST and ALT > 2x URL, or alkaline phosphatase and bilirubin > 1.5 x URL within X days prior to randomization
- •Chronic renal disease as defined by serum creatinine > 1.9
- •Any other serious or unstable clinically significant abnormal findings of laboratory parameters, physical examination, or ECG as determined by the PI.
- •Any other serious or unstable condition that would put the subjects at undue risk as determined by the PI or additional safety monitor.
- •Serious and imminent suicidal or homicidal risk.
- •Psychotropic medication that will not be tapered off at least 7 days prior to screening; withdrawal symptoms must be absent at the time of screening
- •History of nasal disorders or sinonasal surgery, or significant nasal abnormalities based on nasal exam.
- •Received investigational intervention within 30 days prior to randomization
研究组 & 干预措施
NPY/placebo
Experimental
This arm gets NPY first then placebo (saline). The placebo is 0.9% USP-grade saline without NPY.
干预措施: Neuropeptide Y (Drug)
placebo/NPY
Experimental
This arm gets placebo (saline) first then NPY.
干预措施: Neuropeptide Y (Drug)
结局指标
主要结局
Patient Rated Inventory of Side Effects (PRISE)
时间窗: baseline and within 2 hours of administration of NPY
Clinician-administered and safety measures will take place right before and after the administration to identify and evaluate the tolerability of each possible symptom (from baseline to within 2 hours of NPY administration).
次要结局
- Change in Beck Anxiety Inventory (BAI)(at baseline and within 2 hours of administration of NPY)
- State-Trait Anxiety Inventory (STAI)(baseline and within 2 hours of administration of NPY)
研究者
James Murrough
Assistant Professor
Icahn School of Medicine at Mount Sinai
研究点 (1)
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