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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
Summary
This trial is testing a medication called TNX-601 ER to see if it can help people with depression by improving their mood through changes in brain chemicals.
Eligible Conditions
- Depression
- Major Depressive Disorder
- Major Depressive Episode
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Montgomery Asberg Depression Rating Scale (MADRS)
Secondary study objectives
Clinical Global Impression of Severity (CGI-S)
Sheehan Disability Scale (SDS)
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
30 Previous Clinical Trials
4,844 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.
Depression Patient Testimony for trial: Trial Name: NCT05686408 — Phase 2
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