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

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Tonix Pharmaceuticals, Inc.
Study ID
NCT07621237
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Depression
  • Major Depressive Disorder (MDD)
  • Major Depressive Episode (MDE)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • TNX-102 SL — DRUG
    Participants will take 5.6 mg of TNX-102 SL ( 2 x 2.8 mg TNX-102 SL tablets) daily at bedtime.
  • Placebo sublingual tablet — DRUG
    Participants will take placebo ( 2 x placebo sublingual tablets) daily at bedtime.

Study Details

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

Key Dates

Start date
Jun 30, 2026
Status verified
Jun 2026
Primary completion
Feb 29, 2028
Completion
Feb 29, 2028

Study Design

Enrollment
360 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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.
  • Placebo Comparator: Placebo sublingual tablets
    Participants will take placebo ( 2 x placebo sublingual tablets) daily at bedtime.

Primary Outcome Measure

Change from Baseline (Visit 2) in the MADRS total score at Week 6. [ Time Frame: From Day 1 to Week 6 ]

Central Contacts

Locations (25)

FacilityCityStateZIPSite coordinators
IMA Clinical Research- PhoenixPhoenixArizona85012-
Inland Psychiatric Medical Group, Inc. - ChinoChinoCalifornia91710-
Synergy Research - San DiegoLemon GroveCalifornia91945-
Nrc Research InstituteOrangeCalifornia92868-
Artemis Institute For Clinical Research - San DiegoSan DiegoCalifornia92123-
Sunwise Clinical Research, LlcWalnut CreekCalifornia94596-
Clinical Neuroscience Solutions Inc. - JacksonvilleJacksonvilleFlorida32256-
K2 Medical Research - MaitlandMaitlandFlorida32751-
Central Miami Medical Institute Llc.MiamiFlorida33125-
Medical Research Group of Central FloridaOrange CityFlorida32763-
Clinical Neuroscience Solutions Inc. - OrlandoOrlandoFlorida32801-
K2 Medical Research - TampaTampaFlorida33634-
Evergreen Clinical TrialsNorcrossGeorgia30092-
Chicago Research CenterChicagoIllinois60634-
Delricht Research - New OrleansNew OrleansLouisiana70115-
Delricht Research - RockvilleRockvilleMaryland20852-
Activmed Practices & Research, Llc - MethuenMethuenMassachusetts01844-
Redbird ResearchLas VegasNevada89119-
Ima Clinical Research - Nyc MidtownNew YorkNew York10036-
Coastal Carolina Research CenterNorth CharlestonSouth Carolina29405-
Clinical Neuroscience Solutions Inc. - MemphisMephisTennessee38119-
Austin Clinical Trial PartnersAustinTexas78737-
Revival Research Institute, Llc - McKinney, TxMcKinneyTexas75071-
Delricht Research - PlanoPlanoTexas75024-
Boeson Research PvuProvoUtah84604-

Find similar trials in Phoenix, AZ

By condition
Depression
By specialty
PsychiatryMental healthBehavioral health
By research site
IMA Clinical Research- Phoenix· Phoenix, AZInland Psychiatric Medical Group, Inc. - Chino· Chino, CASynergy Research - San Diego· Lemon Grove, CANrc Research Institute· Orange, CAArtemis Institute For Clinical Research - San Diego· San Diego, CASunwise Clinical Research, Llc· Walnut Creek, CA

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