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Serotonin Modulator
TNX-601 ER for Depression (UPLIFT Trial)
Phase 2
Waitlist Available
Research Sponsored by Tonix Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 and week 6
Awards & highlights
UPLIFT Trial 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
UPLIFT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1 and week 6
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 and week 6
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Montgomery Asberg Depression Rating Scale (MADRS)
Secondary outcome measures
Clinical Global Impression of Severity (CGI-S)
Sheehan Disability Scale (SDS)
UPLIFT Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: TNX-601 ER, 39.4 mgExperimental Treatment1 Intervention
1x TNX-601 ER, 39.4 mg, pill taken orally once daily for 6 weeks.
Group II: PlaceboPlacebo Group1 Intervention
Placebo pill taken orally once daily for 6 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TNX-601 ER
2023
Completed Phase 2
~140
Find a Location
Who is running the clinical trial?
Tonix Pharmaceuticals, Inc.Lead Sponsor
29 Previous Clinical Trials
4,747 Total Patients Enrolled
Rho, Inc.Industry Sponsor
24 Previous Clinical Trials
5,631 Total Patients Enrolled
Gregory Sullivan, MDStudy DirectorTonix Pharmaceuticals
7 Previous Clinical Trials
1,635 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You do not have symptoms of severe mental illness like hallucinations or difficulty moving.You have been diagnosed with borderline personality disorder.You have been diagnosed with bipolar disorder, schizophrenia, schizoaffective disorder, major depressive disorder with psychotic features, other psychotic disorder or antisocial personality disorder. You currently have obsessive-compulsive disorder or posttraumatic stress disorder. You have had anorexia nervosa in the past three months or have a history of addiction to opioids or sedative-hypnotic drugs.You can participate in the trial if your primary psychiatric diagnosis is major depressive disorder (MDD), even if you also have other anxiety disorders such as social anxiety disorder (SAD), generalized anxiety disorder (GAD), or panic disorder. However, if your primary diagnosis is one of these anxiety disorders, you cannot participate in the trial.You have been experiencing this particular episode of depression for at least 12 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: TNX-601 ER, 39.4 mg
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Major Depressive Disorder Patient Testimony for trial: Trial Name: NCT05686408 — Phase 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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."
Answered by AI
How many individuals are participating in the scientific experiment?
"Affirmative. The clinicaltrials.gov 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."
Answered by AI
Are there any open slots for volunteers in this research endeavor?
"Per the clinicaltrials.gov 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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
Who else is applying?
What state do they live in?
Colorado
Alabama
California
What site did they apply to?
Behavioral Research Specialists
Artemis Institute for Clinical Research
Mountain View Clinical Research
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
2
3+
Why did patients apply to this trial?
I’ve tried medication(s) and therapy and still have yet to find something that will work. I’m hoping this might!
PatientReceived 2+ prior treatments
I've tried 2 medicines for my depression and neither worked. I've also tried therapy. I'm hoping this will be a better option for me.
PatientReceived 2+ prior treatments
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