Major Depressive Episode (MDE)Phase 2HORIZONNCT07621237
A Study to Evaluate TNX-102 SL Monotherapy Versus Placebo in Participants With Major Depressive Disorder (MDD)
A Phase 2 study testing TNX-102 SL in people with Major Depressive Episode (MDE) and Major Depressive Disorder (MDD), run by Tonix Pharmaceuticals, Inc. at 27 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Depressive Episode (MDE), Major Depressive Disorder (MDD), Depression
- What is being tested?
- TNX-102 SL
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 360 participants
- Where
- 27 sitesUnited States
- Study dates
- 25 Jun 2026to Feb 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
27 sites in 1 country. Contact the study team or a site near you to ask about taking part.
27 sites in 1 country
United States27 sites, 26 recruiting
- Recruiting
Austin Clinical Trial Partners
Austin, Texas, 78737
- Recruiting
Buena Park Research Center
Buena Park, California, 90620
- Recruiting
Chicago Research Center
Chicago, Illinois, 60634
- Recruiting
Inland Psychiatric Medical Group, Inc. - Chino
Chino, California, 91710
- Recruiting
FutureSearch Trials of Dallas
Dallas, Texas, 75251
- Recruiting
Clinical Neuroscience Solutions Inc. - Jacksonville
Jacksonville, Florida, 32256
- Recruiting
Redbird Research
Las Vegas, Nevada, 89119
- Recruiting
Synergy Research - San Diego
Lemon Grove, California, 91945
- Recruiting
K2 Medical Research - Maitland
Maitland, Florida, 32751
- Recruiting
Revival Research Institute, Llc - McKinney, Tx
McKinney, Texas, 75071
- Recruiting
Clinical Neuroscience Solutions Inc. - Memphis
Mephis, Tennessee, 38119
- Recruiting
Activmed Practices & Research, Llc - Methuen
Methuen, Massachusetts, 01844
- Recruiting
Central Miami Medical Institute Llc.
Miami, Florida, 33125
- Withdrawn
Delricht Research - New Orleans
New Orleans, Louisiana, 70115
- Recruiting
Ima Clinical Research - Nyc Midtown
New York, New York, 10036
- Recruiting
Evergreen Clinical Trials
Norcross, Georgia, 30092
- Recruiting
Coastal Carolina Research Center
North Charleston, South Carolina, 29405
- Recruiting
Nrc Research Institute
Orange, California, 92868
- Recruiting
Medical Research Group of Central Florida
Orange City, Florida, 32763
- Recruiting
Clinical Neuroscience Solutions Inc. - Orlando
Orlando, Florida, 32801
- Recruiting
IMA Clinical Research- Phoenix
Phoenix, Arizona, 85012
- Recruiting
Delricht Research - Plano
Plano, Texas, 75024
- Recruiting
Boeson Research Pvu
Provo, Utah, 84604
- Recruiting
Delricht Research - Rockville
Rockville, Maryland, 20852
- Recruiting
Artemis Institute For Clinical Research - San Diego
San Diego, California, 92123
- Recruiting
K2 Medical Research - Tampa
Tampa, Florida, 33634
- Recruiting
Sunwise Clinical Research, Llc
Walnut Creek, California, 94596
About this study
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)
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
- Being tested
- TNX-102 SL, Placebo sublingual tablet
- Keywords
- Depression, TNX-102 SL, Cyclobenzaprine
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TNX-102 SLDrug
Also called cyclobenzaprine, cyclobenzaprine HCl
Participants will take 5.6 mg of TNX-102 SL ( 2 x 2.8 mg TNX-102 SL tablets) daily at bedtime.
Placebo sublingual tabletDrug
Participants will take placebo ( 2 x placebo sublingual tablets) daily at bedtime.
| Study group | Role | What they receive |
|---|---|---|
| TNX-102 SL | Experimental | Participants will take 5.6 mg of TNX-102 SL ( 2 x 2.8 mg TNX-102 SL tablets) daily at bedtime. Receives: Drug: TNX-102 SL |
| Placebo sublingual tablets | Placebo comparator | Participants will take placebo ( 2 x placebo sublingual tablets) daily at bedtime. Receives: Drug: Placebo sublingual tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline (Visit 2) in the MADRS total score at 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.
Measured: From Day 1 to Week 6
Secondary outcomes (4)
Change from Baseline (Visit 2) in the Clinician Global Impression - Severity (CGI-S) score at 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.
Measured: From Day 1 to Week 6
Change from Baseline (Visit 2) in the PROMIS Sleep Disturbance T-score at 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).
Measured: From Day 1 to Week 6
Change from Baseline (Visit 2) in the MADRS total score at 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.
Measured: From Day 1 to Week 4
Change from Baseline (Visit 2) in the MADRS total score at 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.
Measured: From Day 1 to Week 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2026
- Study start25 Jun 2026
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive Episode (MDE)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tonix Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07621237
- Sponsor's protocol ID
- TNX-CY-MD201
- Acronym
- HORIZON
- Status last verified
- Sep 2026
- First submitted
- 27 May 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07621237
- Acronym / sponsor ID
- HORIZON / TNX-CY-MD201
- Keywords
- Depression, TNX-102 SL, Cyclobenzaprine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Tonix Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 25 Jun 2026 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 2 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TNX-102 SL | Experimental | Drug: TNX-102 SLParticipants will take 5.6 mg of TNX-102 SL ( 2 x 2.8 mg TNX-102 SL tablets) daily at bedtime. |
| Placebo sublingual tablets | Placebo comparator | Drug: Placebo sublingual tabletParticipants will take placebo ( 2 x placebo sublingual tablets) daily at bedtime. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TNX-102 SLAlso: cyclobenzaprine, cyclobenzaprine HClParticipants will take 5.6 mg of TNX-102 SL ( 2 x 2.8 mg TNX-102 SL tablets) daily at bedtime. | Drug | TNX-102 SL |
| Placebo sublingual tabletParticipants will take placebo ( 2 x placebo sublingual tablets) daily at bedtime. | Drug | Placebo sublingual tablets |
Primary outcome
Change from Baseline (Visit 2) in the MADRS total score at Week 6.
Time frame: 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.
4 secondary outcomes
Change from Baseline (Visit 2) in the Clinician Global Impression - Severity (CGI-S) score at Week 6
Time frame: From Day 1 to Week 6
Change from Baseline (Visit 2) in the PROMIS Sleep Disturbance T-score at Week 6
Time frame: From Day 1 to Week 6
Change from Baseline (Visit 2) in the MADRS total score at Week 4.
Time frame: From Day 1 to Week 4
Change from Baseline (Visit 2) in the MADRS total score at Week 2.
Time frame: From Day 1 to Week 2
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
27 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TNX-102 SL in people with Major Depressive Episode (MDE) and Major Depressive Disorder (MDD), run by Tonix Pharmaceuticals, Inc. at 27 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Timothy Roush ((862) 799-8599, timothy.roush@tonixpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline (Visit 2) in the MADRS total score at Week 6. (time frame: From Day 1 to Week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.