Fasedienol 鼻喷雾剂用于急性治疗成人社交焦虑症的焦虑 (PALISADE-3) (PALISADE-3)
美国，Fasedienol 鼻喷雾剂的 3 期多中心、随机、双盲、安慰剂对照临床试验，用于急性治疗患有社交焦虑症的成年受试者因公开演讲挑战引起的焦虑，开放标签扩展 (PALISADE -3)
This U.S. Phase 3 clinical trial is designed to evaluate the efficacy, safety, and tolerability of the acute intranasal (i.n.) administration of Fasedienol Nasal Spray (fasedienol) (3.2 µg) to relieve symptoms of acute anxiety in adult subjects ages 18 through 65 with Social Anxiety Disorder induced by a public speaking challenge (PSC) in a clinical setting. In addition, safety and tolerability of i.n. administration of 3.2 µg of fasedienol, as-needed, up to 6 times per day for up to 12 months, will be assessed in those subjects who complete PALISADE-3 and choose to enter the distinct open-label extension phase of the study.
研究概览
研究类型
注册 (实际的)
阶段
- 第三阶段
联系人和位置
学习地点
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Arizona
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Phoenix、Arizona、美国、85012
- Vistagen Clinical Site
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Arkansas
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Fayetteville、Arkansas、美国、72703
- Vistagen Clinical Site
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Little Rock、Arkansas、美国、72211
- Vistagen Clinical Site
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California
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Lafayette、California、美国、94549
- Vistagen Clinical Site
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Oceanside、California、美国、92056
- Vistagen Clinical Site
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Sherman Oaks、California、美国、91403
- Vistagen Clinical Site
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Colorado
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Denver、Colorado、美国、80209
- Vistagen Clinical Site
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Connecticut
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Cromwell、Connecticut、美国、06416
- Vistagen Clinical Site
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Florida
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Jacksonville、Florida、美国、32256
- Vistagen Clinical Site
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Lakeland、Florida、美国、33803
- Vistagen Clinical Site
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Orlando、Florida、美国、32801
- Vistagen Clinical Site
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West Palm Beach、Florida、美国、33407
- Vistagen Clinical Site
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Illinois
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Chicago、Illinois、美国、60612
- Vistagen Clinical Site
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Kansas
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Overland Park、Kansas、美国、66210
- Vistagen Clinical Site
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Maryland
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Baltimore、Maryland、美国、21208
- Vistagen Clinical Site
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Massachusetts
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Boston、Massachusetts、美国、02131
- Vistagen Clinical Site
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Missouri
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Saint Charles、Missouri、美国、63304
- Vistagen Clinical Site
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Nevada
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Las Vegas、Nevada、美国、89119
- Vistagen Clinical Site
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New York
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New York、New York、美国、10128
- Vistagen Clinical Site
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Pennsylvania
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Media、Pennsylvania、美国、19063
- Vistagen Clinical Site
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Tennessee
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Memphis、Tennessee、美国、38119
- Vistagen Clinical Site
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Texas
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Fort Worth、Texas、美国、76104
- Vistagen Clinical Site
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Utah
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Draper、Utah、美国、84020
- Vistagen Clinical Site
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Washington
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Everett、Washington、美国、98201
- Vistagen Clinical Site
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Written informed consent provided prior to conducting any study specific assessment.
- Male and female adults, 18 through 65 years of age, inclusive.
- Current diagnosis of SAD as defined in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5), and confirmed by the Mini-International Neuropsychiatric Interview (MINI).
- Clinician-rated Liebowitz Social Anxiety Scale (LSAS) total score ≥70 at Screening (Visit 1).
- Clinician-rated Hamilton Depression Rating Scale (HAM-D) (17-items) total score <16.
- Female subjects of childbearing potential must be able to commit to the consistent and correct use of an effective method of birth control throughout the study
- Subjects must have normal olfactory function
Exclusion Criteria:
- Any history of bipolar disorder (I or II), schizophrenia, schizoaffective disorder, psychosis, anorexia or bulimia, premenstrual dysphoric disorder, autism spectrum disorder, or obsessive-compulsive disorder.
- Any other current principal or personality disorder (previously known as Axis I or Axis II disorders), except for specific phobias or generalized anxiety disorder, provided that these are not the primary diagnosis.
- Subjects who meet criteria for moderate or severe alcohol use disorder within the 1 year prior to study entry, or any use of illicit substances or tetrahydrocannabinol ("THC") within 2 months prior to study entry.
- In the opinion of the investigator, the subject has a significant risk for suicidal behavior during the course of their participation in the study, or the subject is considered to be an imminent danger to themself or others.
- Clinically significant nasal pathology or history of significant nasal trauma, nasal surgery, total anosmia, or nasal septum perforation that may have damaged the nasal chemosensory epithelium.
- Two or more documented failed adequate treatment trials with a registered medication approved for SAD.
- Currently receiving cognitive-behavioral therapy (CBT), exposure therapy, or acceptance and commitment therapy.
- Subjects taking psychotropic medications within 30 days before Visit 2
- Use of any over-the-counter product, prescription product, off-label treatment, cannabidiol ("CBD"), or herbal preparation for treatment of the symptoms of anxiety or social anxiety within 30 days before Visit 2.
- Prior participation in a clinical trial involving fasedienol.
- Participation in any other clinical trial within the last 30 days or during the course of the current trial.
- Subjects with a positive urine drug screen.
- Women who have a positive urine pregnancy test.
- Women who are currently breastfeeding are not eligible unless they are willing to stop breastfeeding for the duration of the study.
- Subjects who have tested positive and/or have exhibited symptoms consistent with SARS-CoV-2 infection during the 4 weeks prior to Screening (Visit 1).
- Any clinically significant medical history or findings as determined by the Investigator that could interfere with the objectives of the study or put the participant at risk.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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安慰剂比较：安慰剂喷鼻剂
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Nasal spray delivered 20 minutes before the PSC |
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实验性的：Fasedienol 鼻喷雾剂
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Nasal spray delivered 20 minutes before the PSC |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Subjective Units of Distress Scale (SUDS)
大体时间：7 days (Visit 2 to Visit 3)
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The SUDS is a patient self-rated scale that is scored in the range of 0 to 100 (operationalized for participants in this study as 0=totally relaxed or no anxiety and 100=highest distress or anxiety ever felt). |
7 days (Visit 2 to Visit 3)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Global Impression Scale of Improvement (CGI-I)
大体时间：7 days (Visit 2 to Visit 3)
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The CGI-I scale is a clinician-rated scale to assess illness improvement. The CGI-I scale includes one item being scored from 1 (best outcome) to 7 (worst outcome) with 4 being no change. |
7 days (Visit 2 to Visit 3)
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Patient Global Impression of Change (PGI-C)
大体时间：7 days (Visit 2 to Visit 3)
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The PGI-C is a patient self-rated scale to assess improvement. The PGI-C includes 7 items being scored from 1 (best outcome) to 7 (worst outcome) with 4 being no change. |
7 days (Visit 2 to Visit 3)
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合作者和调查者
出版物和有用的链接
有用的网址
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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