Actively Recruiting
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate TNX-102 SL Monotherapy Versus Placebo in Adults With Major Depressive Disorder
Led by Tonix Pharmaceuticals, Inc. · Updated on 2026-06-02
360
Participants Needed
25
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the effects of a drug called TNX-102 SL on adults with moderate to severe major depressive disorder (MDD). This clinical trial aims to find out if TNX-102 SL improves depression symptoms compared to a placebo and to assess its safety. The study focuses on changes in depression symptoms measured by a rating scale over six weeks. Participants will take either 5.6 mg of TNX-102 SL (two 2.8 mg tablets) or placebo tablets every night at bedtime for six weeks. The study is randomized and double-blind, meaning neither participants nor researchers know who receives the drug or placebo. Checkups and tests will take place at the clinic every two weeks during the treatment period. During the trial, participants will have depression symptom assessments and other evaluations to monitor safety and treatment effects. The main measurement is the change in depression rating scores from the start to week six. Participants will be closely followed throughout the six-week treatment, with regular visits every two weeks for monitoring and questionnaires.
CONDITIONS
Brief Title
A Study to Evaluate TNX-102 SL Monotherapy Versus Placebo in Participants With Major Depressive Disorder (MDD)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Primary DSM-5 diagnosis of current major depressive disorder (MDD)
- Current major depressive episode lasting between 6 weeks and 18 months
- No psychotic or catatonic features present
- Able to read and understand English
- Able to provide written informed consent to participate
You will not qualify if you...
- Diagnosis of lifetime bipolar disorder, schizophrenia, schizoaffective disorder, MDD with psychotic features, other psychotic disorders, or antisocial personality disorder
- Current obsessive-compulsive disorder or posttraumatic stress disorder
- Current anorexia nervosa within past 3 months
- Known or suspected borderline personality disorder
- Primary diagnosis of generalized anxiety disorder, social anxiety disorder, or panic disorder instead of MDD
- Treatment refractory MDD with failure of 2 or more antidepressant treatments
- History of substance use disorder or alcohol use disorder within last 12 months
- Use of antidepressants within 4 weeks before baseline visit (6 weeks for fluoxetine) except as allowed by protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 weeks
Participants take TNX-102 SL or placebo daily at bedtime and are monitored for treatment effects.
Baseline visit and weekly follow-up visits for up to 6 weeks
Trial Site Locations
Total: 25 locations
1
IMA Clinical Research- Phoenix
Phoenix, Arizona, United States, 85012
Not Yet Recruiting
2
Inland Psychiatric Medical Group, Inc. - Chino
Chino, California, United States, 91710
Not Yet Recruiting
3
Synergy Research - San Diego
Lemon Grove, California, United States, 91945
Not Yet Recruiting
4
Nrc Research Institute
Orange, California, United States, 92868
Not Yet Recruiting
5
Artemis Institute For Clinical Research - San Diego
San Diego, California, United States, 92123
Not Yet Recruiting
6
Sunwise Clinical Research, Llc
Walnut Creek, California, United States, 94596
Not Yet Recruiting
7
Clinical Neuroscience Solutions Inc. - Jacksonville
Jacksonville, Florida, United States, 32256
Not Yet Recruiting
8
K2 Medical Research - Maitland
Maitland, Florida, United States, 32751
Not Yet Recruiting
9
Central Miami Medical Institute Llc.
Miami, Florida, United States, 33125
Not Yet Recruiting
10
Medical Research Group of Central Florida
Orange City, Florida, United States, 32763
Not Yet Recruiting
11
Clinical Neuroscience Solutions Inc. - Orlando
Orlando, Florida, United States, 32801
Actively Recruiting
12
K2 Medical Research - Tampa
Tampa, Florida, United States, 33634
Not Yet Recruiting
13
Evergreen Clinical Trials
Norcross, Georgia, United States, 30092
Not Yet Recruiting
14
Chicago Research Center
Chicago, Illinois, United States, 60634
Not Yet Recruiting
15
Delricht Research - New Orleans
New Orleans, Louisiana, United States, 70115
Actively Recruiting
16
Delricht Research - Rockville
Rockville, Maryland, United States, 20852
Not Yet Recruiting
17
Activmed Practices & Research, Llc - Methuen
Methuen, Massachusetts, United States, 01844
Not Yet Recruiting
18
Redbird Research
Las Vegas, Nevada, United States, 89119
Not Yet Recruiting
19
Ima Clinical Research - Nyc Midtown
New York, New York, United States, 10036
Not Yet Recruiting
20
Coastal Carolina Research Center
North Charleston, South Carolina, United States, 29405
Not Yet Recruiting
21
Clinical Neuroscience Solutions Inc. - Memphis
Mephis, Tennessee, United States, 38119
Not Yet Recruiting
22
Austin Clinical Trial Partners
Austin, Texas, United States, 78737
Not Yet Recruiting
23
Revival Research Institute, Llc - McKinney, Tx
McKinney, Texas, United States, 75071
Not Yet Recruiting
24
Delricht Research - Plano
Plano, Texas, United States, 75024
Not Yet Recruiting
25
Boeson Research Pvu
Provo, Utah, United States, 84604
Not Yet Recruiting
Research Team
T
Timothy Roush
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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