TNX-601 ER for Depression

(UPLIFT Trial)

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called TNX-601 ER, an extended-release medication, for individuals with Major Depressive Disorder (MDD). The goal is to evaluate the treatment's effectiveness compared to a placebo (a pill with no active medicine) and to assess its safety and tolerability. Participants will take either TNX-601 ER or a placebo tablet daily for six weeks. It suits those who have experienced a major depressive episode lasting at least 12 weeks and do not exhibit psychotic or catatonic features. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.

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.

Is there any evidence suggesting that TNX-601 ER is likely to be safe for humans?

Research has shown that TNX-601 ER is generally safe for people. In one study, most participants did not experience serious problems, indicating a good safety record. Although one serious side effect was reported, details about it are not available. This suggests that TNX-601 ER could be safe for many, but individual reactions can differ. Always consult a healthcare provider with any concerns. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for depression?

TNX-601 ER is unique because it offers a new way to tackle depression with its extended-release formulation. Unlike many current treatments like SSRIs and SNRIs, which often take weeks to show effects, TNX-601 ER may provide quicker relief by maintaining stable drug levels in the body over time. Researchers are excited about its potential to improve adherence and reduce side effects, making it a promising option for those who have struggled with traditional antidepressants.

What evidence suggests that TNX-601 ER might be an effective treatment for depression?

Research has shown that TNX-601 ER was tested as a possible treatment for major depressive disorder (MDD). However, recent results led to the decision to stop developing TNX-601 ER because it did not consistently help people with depression. Although initial hope existed for TNX-601 ER, the findings suggest it may not be an effective treatment for MDD. Therefore, it is no longer considered a promising option for this condition. ^{1 2 4 6 7}

Who Is on the Research Team?

Gregory Sullivan, MD

Principal Investigator

Tonix Pharmaceuticals

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• TNX-601 ER

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05686408

NCT05686408 | Study to Evaluate TNX-601 ER ... This is a Phase 2, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy, safety, and tolerability of TNX-601 ER ...

2. ir.tonixpharma.com ir.tonixpharma.com/news-events/press-releases/detail/1435/tonix-pharmaceuticals-announces-topline-results-from-phase

Press Releases Tonix is discontinuing development of TNX-601 ER based on the efficacy results of this study. Tonix expects topline data results in December 2023.

3. ctv.veeva.com ctv.veeva.com/study/study-to-evaluate-tnx-601-er-monotherapy-versus-placebo-in-patients-with-major-depressive-disorder

Study to Evaluate TNX-601 ER Monotherapy Versus Placebo ... This is a Phase 2, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy, safety, and tolerability of TNX- ...

4. finance.yahoo.com finance.yahoo.com/news/tonix-pharmaceuticals-announces-topline-results-210000916.html

Tonix Pharmaceuticals Announces Topline Results from ... Tonix Pharmaceuticals Announces Topline Results from Phase 2 Proof-of-Concept Study of TNX-601 ER for the Treatment of Major Depressive Disorder.

5. ir.tonixpharma.com ir.tonixpharma.com/news-events/press-releases/detail/1430/tonix-pharmaceuticals-completes-clinical-stage-of-phase-2

Tonix Pharmaceuticals Completes Clinical Stage of Phase ... TNX-601 ER is being developed as a monotherapy and first-line treatment for MDD and works by a distinct mechanism of action as compared to traditional ...

6. tonixpharma.com tonixpharma.com/wp-content/uploads/2023/06/ASCP-Poster-2023-A-Randomized-Placebo-Controlled-Multicenter-Trial-of-Monotherapy-with-TNX-601-ER.pdf

A Randomized Placebo-Controlled Multicenter Trial of ... TNX-601 ER was formulated with attention to potential abuse deterrent properties: lower solubility of hemioxalate salt (reduced extraction ...

7. withpower.com withpower.com/trial/phase-2-disease-1-2023-5be87

TNX-601 ER for Depression (UPLIFT 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.