A Study to Evaluate TNX-102 SL Monotherapy Versus Placebo in Participants With Major Depressive Disorder (MDD)

NCT07621237
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Phase
Phase 2
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Recruitment status
Recruiting
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Participants
360
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Lead sponsor
Tonix Pharmaceuticals, Inc.
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Start date
2026-06-01
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Number of sites
25
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Summary
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
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Acronym
HORIZON
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Short title
A Study to Evaluate TNX-102 SL Monotherapy Versus Placebo in Participants With Major Depressive Disorder (MDD)
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Official title
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)
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Control arm
Placebo
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 2
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Study type
Interventional
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Completion date
2028-02-01
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First posted
2026-06-02
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Registry last updated
2026-06-02
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Primary completion date
2028-02-01
clinicaltrials.gov
Start date
2026-06-01
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Participants
360
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Participant count basis
Estimated
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Planned participants
360
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Protocol amendments
0
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Number of sites
25
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Registry sponsor category
Industry
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Lead sponsor
Tonix Pharmaceuticals, Inc.
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07621237
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ClinicalTrials.gov ID
NCT07621237
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Quadruple masking
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

  1. Change from Baseline (Visit 2) in the MADRS total score at Week 6.

    Timeframe: From Day 1 to Week 6

    Change from Baseline (Visit 2) in the MADRS total score at Week 6. Scores range from 0 to 60. Lower scores indicate less depression.

  1. Change from Baseline (Visit 2) in the Clinician Global Impression - Severity (CGI-S) score at Week 6

    Timeframe: From Day 1 to Week 6

    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.

  2. Change from Baseline (Visit 2) in the PROMIS Sleep Disturbance T-score at Week 6

    Timeframe: From Day 1 to Week 6

    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).

  3. Change from Baseline (Visit 2) in the MADRS total score at Week 4.

    Timeframe: From Day 1 to Week 4

    Change from Baseline (Visit 2) in the MADRS total score at Week 4. Scores range from 0 to 60. Lower scores indicate less depression.

  4. Change from Baseline (Visit 2) in the MADRS total score at Week 2.

    Timeframe: From Day 1 to Week 2

    Change from Baseline (Visit 2) in the MADRS total score at Week 2. Scores range from 0 to 60. Lower scores indicate less depression.

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • 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.

  • 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)
Sources for eligibility
clinicaltrials.gov

  • IMA Clinical Research- PhoenixPhoenix, United StatesNot yet recruiting
  • Inland Psychiatric Medical Group, Inc. - ChinoChino, United StatesNot yet recruiting
  • Synergy Research - San DiegoLemon Grove, United StatesNot yet recruiting
  • Nrc Research InstituteOrange, United StatesNot yet recruiting
  • Artemis Institute For Clinical Research - San DiegoSan Diego, United StatesNot yet recruiting
  • Sunwise Clinical Research, LlcWalnut Creek, United StatesNot yet recruiting
  • Clinical Neuroscience Solutions Inc. - JacksonvilleJacksonville, United StatesNot yet recruiting
  • K2 Medical Research - MaitlandMaitland, United StatesNot yet recruiting
  • Central Miami Medical Institute Llc.Miami, United StatesNot yet recruiting
  • Medical Research Group of Central FloridaOrange City, United StatesNot yet recruiting
  • Clinical Neuroscience Solutions Inc. - OrlandoOrlando, United StatesRecruiting
  • K2 Medical Research - TampaTampa, United StatesNot yet recruiting
  • Evergreen Clinical TrialsNorcross, United StatesNot yet recruiting
  • Chicago Research CenterChicago, United StatesNot yet recruiting
  • Delricht Research - New OrleansNew Orleans, United StatesRecruiting
  • Delricht Research - RockvilleRockville, United StatesNot yet recruiting
  • Activmed Practices & Research, Llc - MethuenMethuen, United StatesNot yet recruiting
  • Redbird ResearchLas Vegas, United StatesNot yet recruiting
  • Ima Clinical Research - Nyc MidtownNew York, United StatesNot yet recruiting
  • Coastal Carolina Research CenterNorth Charleston, United StatesNot yet recruiting
  • Clinical Neuroscience Solutions Inc. - MemphisMephis, United StatesNot yet recruiting
  • Austin Clinical Trial PartnersAustin, United StatesNot yet recruiting
  • Revival Research Institute, Llc - McKinney, TxMcKinney, United StatesNot yet recruiting
  • Delricht Research - PlanoPlano, United StatesNot yet recruiting
  • Boeson Research PvuProvo, United StatesNot yet recruiting
Sources for sites
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (2)

Targets (2)