A Study to Evaluate TNX-102 SL Monotherapy Versus Placebo in Participants With Major Depressive Disorder (MDD) (HORIZON)
2026年6月1日 更新者：Tonix Pharmaceuticals, Inc.
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy, Safety, and Tolerability of TNX-102 SL Monotherapy Versus Placebo in Participants With Major Depressive Disorder (MDD)
The goal of this clinical trial is to learn if a drug called TNX-102 SL works to treat moderate to severe major depressive disorder in adults. It will also learn about the safety of TNX-102 SL. The main questions it aims to answer are:
Does TNX-102 SL improve depression symptoms according to a depression symptom rating scale? What medical problems do participants have when taking TNX-102 SL?
Researchers will compare TNX-102 SL to a placebo (a look-alike substance that contains no drug) to see if TNX-102 SL works to treat major depressive disorder.
Participants will:
Take TNX-102 SL or a placebo every night at bedtime for 6 weeks Visit the clinic once every 2 weeks for checkups and tests
研究概览
研究类型
介入性
注册 (估计的)
360
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Timothy Roush
- 电话号码：(862) 799-8599
- 邮箱：timothy.roush@tonixpharma.com
学习地点
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Arizona
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Phoenix、Arizona、美国、85012
- 尚未招聘
- IMA Clinical Research- Phoenix
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California
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Chino、California、美国、91710
- 尚未招聘
- Inland Psychiatric Medical Group, Inc. - Chino
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Lemon Grove、California、美国、91945
- 尚未招聘
- Synergy Research - San Diego
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Orange、California、美国、92868
- 尚未招聘
- NRC Research Institute
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San Diego、California、美国、92123
- 尚未招聘
- Artemis Institute For Clinical Research - San Diego
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Walnut Creek、California、美国、94596
- 尚未招聘
- Sunwise Clinical Research, Llc
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Florida
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Jacksonville、Florida、美国、32256
- 尚未招聘
- Clinical Neuroscience Solutions Inc. - Jacksonville
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Maitland、Florida、美国、32751
- 尚未招聘
- K2 Medical Research - Maitland
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Miami、Florida、美国、33125
- 尚未招聘
- Central Miami Medical Institute Llc.
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Orange City、Florida、美国、32763
- 尚未招聘
- Medical Research Group of Central Florida
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Orlando、Florida、美国、32801
- 招聘中
- Clinical Neuroscience Solutions Inc. - Orlando
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Tampa、Florida、美国、33634
- 尚未招聘
- K2 Medical Research - Tampa
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Georgia
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Norcross、Georgia、美国、30092
- 尚未招聘
- Evergreen Clinical Trials
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Illinois
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Chicago、Illinois、美国、60634
- 尚未招聘
- Chicago Research Center
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Louisiana
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New Orleans、Louisiana、美国、70115
- 招聘中
- Delricht Research - New Orleans
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Maryland
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Rockville、Maryland、美国、20852
- 尚未招聘
- Delricht Research - Rockville
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Massachusetts
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Methuen、Massachusetts、美国、01844
- 尚未招聘
- Activmed Practices & Research, Llc - Methuen
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Nevada
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Las Vegas、Nevada、美国、89119
- 尚未招聘
- Redbird Research
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New York
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New York、New York、美国、10036
- 尚未招聘
- Ima Clinical Research - Nyc Midtown
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South Carolina
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North Charleston、South Carolina、美国、29405
- 尚未招聘
- Coastal Carolina Research Center
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Tennessee
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Mephis、Tennessee、美国、38119
- 尚未招聘
- Clinical Neuroscience Solutions Inc. - Memphis
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Texas
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Austin、Texas、美国、78737
- 尚未招聘
- Austin Clinical Trial Partners
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McKinney、Texas、美国、75071
- 尚未招聘
- Revival Research Institute, Llc - McKinney, Tx
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Plano、Texas、美国、75024
- 尚未招聘
- Delricht Research - Plano
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Utah
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Provo、Utah、美国、84604
- 尚未招聘
- Boeson Research Pvu
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- Primary DSM-5 diagnosis of current MDD.
- The duration of the current MDE must be between 6 weeks and 18 months.
- Without psychotic or catatonic features.
- Capable of reading and understanding English and able to provide written informed consent to participate.
Exclusion Criteria:
- Diagnosis of DSM-5-defined lifetime bipolar disorder (I, II, or unspecified), schizophrenia, schizoaffective disorder, MDD with psychotic features, other psychotic disorder, or antisocial personality disorder; current (past month) obsessive-compulsive disorder; current (past month) posttraumatic stress disorder; current (past 3 months) anorexia nervosa,
- Diagnosis of borderline personality disorder that is known, suspected
- Participants with comorbid generalized anxiety disorder (GAD), social anxiety disorder (SAD), or panic disorder are excluded only if the GAD, SAD, or panic disorder is considered the primary psychiatric diagnosis, rather than MDD.
- Participants with treatment refractory MDD, ie, previously having failed in their lifetime ≥2 treatments (due to inadequate efficacy) with at least 2 different classes of antidepressants of adequate dose, duration, and treatment adherence.
- History of substance use disorder and/or alcohol use disorder during the preceding 12 months
- Use of antidepressants (including ketamine/esketamine, St. John's Wort, S-adenosyl methionine, and/or trazodone used as an antidepressant) within 4 weeks of Baseline (Visit 2), except for fluoxetine, which must not be within 6 weeks of Baseline (Visit 2)
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
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：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：TNX-102 SL
Participants will take 5.6 mg of TNX-102 SL ( 2 x 2.8 mg TNX-102 SL tablets) daily at bedtime.
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Participants will take 5.6 mg of TNX-102 SL ( 2 x 2.8 mg TNX-102 SL tablets) daily at bedtime.
其他名称：
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安慰剂比较：Placebo sublingual tablets
Participants will take placebo ( 2 x placebo sublingual tablets) daily at bedtime.
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Participants will take placebo ( 2 x placebo sublingual tablets) daily at bedtime.
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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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Change from Baseline (Visit 2) in the MADRS total score at Week 6.
大体时间：From Day 1 to Week 6
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Change from Baseline (Visit 2) in the MADRS total score at Week 6. Scores range from 0 to 60. Lower scores indicate less depression.
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From Day 1 to Week 6
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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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Change from Baseline (Visit 2) in the Clinician Global Impression - Severity (CGI-S) score at Week 6
大体时间：From Day 1 to Week 6
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Change from Baseline (Visit 2) in the Clinical Global Impression of Severity Scale (CGI-S) score at Week 6. Scores range from 1 to 5. Lower scores indicate less severe illness.
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From Day 1 to Week 6
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Change from Baseline (Visit 2) in the PROMIS Sleep Disturbance T-score at Week 6
大体时间：From Day 1 to Week 6
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Change from Baseline (Visit 2) in the PROMIS Sleep Disturbance T-score at Week 6.
The Patient-Reported Outcome Measurement Information System (PROMIS) sleep disturbance instrument consists of 8 items in which responses are scored 1 to 5 for each item.
PROMIS scores are presented as T-scores in which the raw score has been rescaled into a standardized score with a mean of 50 and a standard deviation of 10.
Higher T-scores represent more of the concept being measured (in this case, sleep disturbance).
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From Day 1 to Week 6
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Change from Baseline (Visit 2) in the MADRS total score at Week 4.
大体时间：From Day 1 to Week 4
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Change from Baseline (Visit 2) in the MADRS total score at Week 4. Scores range from 0 to 60. Lower scores indicate less depression.
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From Day 1 to Week 4
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Change from Baseline (Visit 2) in the MADRS total score at Week 2.
大体时间：From Day 1 to Week 2
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Change from Baseline (Visit 2) in the MADRS total score at Week 2. Scores range from 0 to 60. Lower scores indicate less depression.
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From Day 1 to Week 2
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年6月1日
初级完成 (估计的)
2028年2月1日
研究完成 (估计的)
2028年2月1日
研究注册日期
首次提交
2026年5月27日
首先提交符合 QC 标准的
2026年6月1日
首次发布 (实际的)
2026年6月2日
研究记录更新
最后更新发布 (实际的)
2026年6月2日
上次提交的符合 QC 标准的更新
2026年6月1日
最后验证
2026年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
TNX-102 SL的临床试验
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Tonix Pharmaceuticals, Inc.Altasciences Company Inc.完全的
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Tonix Pharmaceuticals, Inc.Syneos Health主动，不招人
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Tonix Pharmaceuticals, Inc.完全的新冠肺炎 | 长COVID | SARS-CoV-2 (PASC) 感染的急性后遗症 | 长途 COVID美国
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Tonix Pharmaceuticals, Inc.完全的
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University of North Carolina, Chapel HillUnited States Department of Defense; Mclean Hospital; Tonix Pharmaceuticals, Inc.; Cooper University...招聘中