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

1. juni 2026 opdateret af: 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

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

360

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Forenede Stater
    • Arizona
      • Phoenix, Arizona, Forenede Stater, 85012
        • Ikke rekrutterer endnu
        • IMA Clinical Research- Phoenix
    • California
      • Chino, California, Forenede Stater, 91710
        • Ikke rekrutterer endnu
        • Inland Psychiatric Medical Group, Inc. - Chino
      • Lemon Grove, California, Forenede Stater, 91945
        • Ikke rekrutterer endnu
        • Synergy Research - San Diego
      • Orange, California, Forenede Stater, 92868
        • Ikke rekrutterer endnu
        • NRC Research Institute
      • San Diego, California, Forenede Stater, 92123
        • Ikke rekrutterer endnu
        • Artemis Institute For Clinical Research - San Diego
      • Walnut Creek, California, Forenede Stater, 94596
        • Ikke rekrutterer endnu
        • Sunwise Clinical Research, Llc
    • Florida
      • Jacksonville, Florida, Forenede Stater, 32256
        • Ikke rekrutterer endnu
        • Clinical Neuroscience Solutions Inc. - Jacksonville
      • Maitland, Florida, Forenede Stater, 32751
        • Ikke rekrutterer endnu
        • K2 Medical Research - Maitland
      • Miami, Florida, Forenede Stater, 33125
        • Ikke rekrutterer endnu
        • Central Miami Medical Institute Llc.
      • Orange City, Florida, Forenede Stater, 32763
        • Ikke rekrutterer endnu
        • Medical Research Group of Central Florida
      • Orlando, Florida, Forenede Stater, 32801
        • Rekruttering
        • Clinical Neuroscience Solutions Inc. - Orlando
      • Tampa, Florida, Forenede Stater, 33634
        • Ikke rekrutterer endnu
        • K2 Medical Research - Tampa
    • Georgia
      • Norcross, Georgia, Forenede Stater, 30092
        • Ikke rekrutterer endnu
        • Evergreen Clinical Trials
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60634
        • Ikke rekrutterer endnu
        • Chicago Research Center
    • Louisiana
      • New Orleans, Louisiana, Forenede Stater, 70115
        • Rekruttering
        • Delricht Research - New Orleans
    • Maryland
      • Rockville, Maryland, Forenede Stater, 20852
        • Ikke rekrutterer endnu
        • Delricht Research - Rockville
    • Massachusetts
      • Methuen, Massachusetts, Forenede Stater, 01844
        • Ikke rekrutterer endnu
        • Activmed Practices & Research, Llc - Methuen
    • Nevada
      • Las Vegas, Nevada, Forenede Stater, 89119
        • Ikke rekrutterer endnu
        • Redbird Research
    • New York
      • New York, New York, Forenede Stater, 10036
        • Ikke rekrutterer endnu
        • Ima Clinical Research - Nyc Midtown
    • South Carolina
      • North Charleston, South Carolina, Forenede Stater, 29405
        • Ikke rekrutterer endnu
        • Coastal Carolina Research Center
    • Tennessee
      • Mephis, Tennessee, Forenede Stater, 38119
        • Ikke rekrutterer endnu
        • Clinical Neuroscience Solutions Inc. - Memphis
    • Texas
      • Austin, Texas, Forenede Stater, 78737
        • Ikke rekrutterer endnu
        • Austin Clinical Trial Partners
      • McKinney, Texas, Forenede Stater, 75071
        • Ikke rekrutterer endnu
        • Revival Research Institute, Llc - McKinney, Tx
      • Plano, Texas, Forenede Stater, 75024
        • Ikke rekrutterer endnu
        • Delricht Research - Plano
    • Utah
      • Provo, Utah, Forenede Stater, 84604
        • Ikke rekrutterer endnu
        • Boeson Research Pvu

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Medicin: 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.
Andre navne:
  • cyclobenzaprin HCl
  • cyclobenzaprin
Placebo komparator: Placebo sublingual tablets
Participants will take placebo ( 2 x placebo sublingual tablets) daily at bedtime.
Medicin: Placebo sublingual tablet
Participants will take placebo ( 2 x placebo sublingual tablets) daily at bedtime.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change from Baseline (Visit 2) in the MADRS total score at Week 6.
Tidsramme: 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.
From Day 1 to Week 6

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change from Baseline (Visit 2) in the Clinician Global Impression - Severity (CGI-S) score at Week 6
Tidsramme: 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.
From Day 1 to Week 6
Change from Baseline (Visit 2) in the PROMIS Sleep Disturbance T-score at Week 6
Tidsramme: 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).
From Day 1 to Week 6
Change from Baseline (Visit 2) in the MADRS total score at Week 4.
Tidsramme: 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.
From Day 1 to Week 4
Change from Baseline (Visit 2) in the MADRS total score at Week 2.
Tidsramme: 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.
From Day 1 to Week 2

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Tonix Pharmaceuticals, Inc.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juni 2026

Primær færdiggørelse (Anslået)

1. februar 2028

Studieafslutning (Anslået)

1. februar 2028

Datoer for studieregistrering

Først indsendt

27. maj 2026

Først indsendt, der opfyldte QC-kriterier

1. juni 2026

Først opslået (Faktiske)

2. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

2. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • TNX-CY-MD201

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Depression

Kliniske forsøg med TNX-102 SL

Søg i lignende forsøg

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Betingelser

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