TNX-601 ER, 39.4 mg for Major Depressive Disorder

Clinical Neuroscience Solutions, Inc, Orlando, FL
Major Depressive Disorder+5 More ConditionsTNX-601 ER - Drug
18 - 65
All Sexes

Study Summary

This trial tests a new medicine to treat Major Depressive Disorder (MDD). It is a safe, controlled study with real medicine and placebo.

Eligible Conditions
  • Major Depressive Disorder
  • Depression
  • Major Depressive Episode
  • Severe Depression

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 2

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: Day 1 and Week 6

Week 6
Clinical Global Impression of Severity (CGI-S)
Montgomery Asberg Depression Rating Scale (MADRS)
Sheehan Disability Scale (SDS)

Trial Safety

Phase-Based Safety

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

TNX-601 ER, 39.4 mg
1 of 2
1 of 2

Experimental Treatment

Non-Treatment Group

300 Total Participants · 2 Treatment Groups

Primary Treatment: TNX-601 ER, 39.4 mg · Has Placebo Group · Phase 2

TNX-601 ER, 39.4 mg
Experimental Group · 1 Intervention: TNX-601 ER · Intervention Types: Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: day 1 and week 6

Who is running the clinical trial?

Tonix Pharmaceuticals, Inc.Lead Sponsor
28 Previous Clinical Trials
5,526 Total Patients Enrolled
Rho, Inc.Industry Sponsor
23 Previous Clinical Trials
5,607 Total Patients Enrolled
Gregory Sullivan, MDStudy DirectorTonix Pharmaceuticals
6 Previous Clinical Trials
2,007 Total Patients Enrolled

Eligibility Criteria

Age 18 - 65 · All Participants · 2 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have been experiencing this particular episode of depression for at least 12 weeks.
You do not have symptoms of severe mental illness like hallucinations or difficulty moving.

Frequently Asked Questions

Are elderly individuals accepted into the research trial?

"The requirements for entering this clinical trial stipulate that the minimum age must be 18 and no older than 65." - Anonymous Online Contributor

Unverified Answer

How many individuals are participating in the scientific experiment?

"Affirmative. The website details that this trial, which was posted on March 2nd 2023 and updated 13 days later, is currently searching for 300 volunteers to be enrolled at one location." - Anonymous Online Contributor

Unverified Answer

Are there any open slots for volunteers in this research endeavor?

"Per the database, this medical study is actively seeking volunteers for participation; having first been posted on March 2nd 2023 and most recently updated on March 13th of the same year." - Anonymous Online Contributor

Unverified Answer

Is it possible to join this clinical research program?

"To be eligible for enrollment in this clinical trial, participants must have a diagnosis of depression and fall within the age range 18 to 65. The study is hoping to recruit approximately 300 qualified individuals." - Anonymous Online Contributor

Unverified Answer

Has the FDA sanctioned TNX-601 ER, 39.4 mg for public use?

"Our assessment of TNX-601 ER, 39.4 mg's safety is a 2 because there has been some evidence collected in regards to its safety but none which can support its efficacy yet." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.