TNX-601 ER for Depression

(UPLIFT Trial)

Recruiting at 28 trial locations

Overseen By Project Manager

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Tonix Pharmaceuticals, Inc.

Disqualifiers: Bipolar, Schizophrenia, Antisocial, Borderline, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

132 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

How is the drug TNX-601 ER different from other depression treatments?

TNX-601 ER is unique because it may involve a mechanism similar to traxoprodil, which targets specific brain pathways (BDNF/ERK/CREB and AKT/FOXO/Bim) for rapid and long-lasting antidepressant effects. This approach is different from traditional antidepressants, which often take longer to show effects. ^{1 2 3 4 5}

What is the purpose of this trial?

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.

Research Team

Gregory Sullivan, MD

Principal Investigator

Tonix Pharmaceuticals

Eligibility Criteria

Inclusion Criteria

You do not have symptoms of severe mental illness like hallucinations or difficulty moving.

Have a primary DSM-5 diagnosis of current MDD.

You have been experiencing this particular episode of depression for at least 12 weeks.

Exclusion Criteria

Patients with treatment refractory MDD, ie, previously having in their lifetime failed ≥2 treatments with at least 2 different classes of antidepressants of adequate dose, duration, and treatment adherence

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either TNX-601 ER or placebo for 6 weeks

6 weeks

Daily oral administration

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Placebo
• TNX-601 ER

Participant Groups

Group I: TNX-601 ER, 39.4 mg Experimental Treatment 1 Intervention

1x TNX-601 ER, 39.4 mg, tablet taken orally once daily for 6 weeks.

Group II: Placebo Placebo Group 1 Intervention

Placebo tablet taken orally once daily for 6 weeks.

Who Is Running the Clinical Trial?

Tonix Pharmaceuticals, Inc.

Lead Sponsor

Trials

31

Recruited

4,900+

Rho, Inc.

Industry Sponsor

Trials

25

Recruited

5,800+

References

1. United States pubmed.ncbi.nlm.nih.gov

Traxoprodil Produces Antidepressant-Like Behaviors in Chronic Unpredictable Mild Stress Mice through BDNF/ERK/CREB and AKT/FOXO/Bim Signaling Pathway. [2023]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Rb1, the Primary Active Ingredient in Panax ginseng C.A. Meyer, Exerts Antidepressant-Like Effects via the BDNF-Trkb-CREB Pathway. [2020]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Esmethadone (REL-1017) and Other Uncompetitive NMDAR Channel Blockers May Improve Mood Disorders via Modulation of Synaptic Kinase-Mediated Signaling. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Antidepressant efficacy of ketamine in treatment-resistant major depression: a two-site randomized controlled trial. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Regionally specific regulation of ERK MAP kinase in a model of antidepressant-sensitive chronic depression. [2022]