NV-5138 for Treatment-Resistant Depression

No longer recruiting at 1 trial location

Overseen By Welton Oneal

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Navitor Pharmaceuticals, Inc.

Must be taking: Antidepressants

Disqualifiers: Psychotic disorder, Bipolar, PTSD, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 5 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called NV-5138, a potential drug for treatment-resistant depression (TRD), where typical antidepressants prove ineffective. Researchers are testing NV-5138 to assess its effectiveness and safety compared to a placebo. Suitable participants should have major depressive disorder, have not responded to at least two antidepressant treatments, and currently be on a stable dose of an antidepressant. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial requires participants to stay on a stable dose of their current antidepressant medication throughout the study.

Is there any evidence suggesting that NV-5138 is likely to be safe for humans?

Research has shown that NV-5138 is well tolerated by people. In one study with healthy volunteers, daily use of NV-5138 did not cause significant negative side effects. However, specific information on any negative effects from NV-5138 is not available in the sources provided.

This trial is in Phase 2, indicating that earlier studies found NV-5138 safe enough for testing in more people. This phase evaluates the treatment's effectiveness while monitoring safety. Consulting a healthcare provider is advisable to understand the possible risks and benefits. ^{1 2 3 4 5}

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

Unlike the standard treatments for treatment-resistant depression, which typically involve SSRIs, SNRIs, and other antidepressant medications, NV-5138 offers a fresh approach by targeting the brain's mTORC1 pathway. This mechanism is thought to play a crucial role in synaptic connections and brain plasticity, potentially leading to faster and more effective relief of depressive symptoms. Researchers are excited about NV-5138 because it holds the promise of acting quickly, possibly within days, compared to the weeks or months it can take for traditional antidepressants to show benefits.

What evidence suggests that NV-5138 might be an effective treatment for treatment-resistant depression?

Research has shown that NV-5138, which participants in this trial may receive, could be a promising fast-acting antidepressant for people with treatment-resistant depression. Studies have found that a single dose of NV-5138 can quickly and effectively improve symptoms for an extended period. It works by influencing specific brain areas that control mood and motivation. In previous studies, patients demonstrated significant improvements in their depression symptoms compared to those who took a placebo. This suggests NV-5138 could offer hope for those who haven't found relief with other treatments. ^{1 4 6 7 8}

Who Is on the Research Team?

Randy Owen, MD

Principal Investigator

Medical Monitor

Are You a Good Fit for This Trial?

Adults aged 18-70 with Treatment Resistant Depression (TRD), who have tried and not responded to 2-4 antidepressant therapies, can join this study. They must be diagnosed with Major Depressive Disorder without psychotic features and show a certain level of depression severity on standard rating scales.

Inclusion Criteria

I've tried 2-4 ADT therapies for my condition without success.

I have been on a stable dose of my depression medication for at least 2 weeks.

Exclusion Criteria

You have been diagnosed with Psychosis

You have been diagnosed with Bipolar Disorder

You have been diagnosed with Hepatitis C

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive NV-5138 or placebo once daily for 5 weeks

5 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• matched placebo
• NV-5138

Trial Overview The trial is testing NV-5138's effectiveness compared to a placebo in treating TRD. Participants will either receive NV-5138 or an inactive substance without knowing which one they're getting, to measure true effects of the drug.

How Is the Trial Designed?

Group I: NV-5138 400 mg oral capsules Experimental Treatment 1 Intervention

Either 2 or 4 400 mg oral capsules administered once daily

Group II: matched placebo Placebo Group 1 Intervention

2 or 4 oral capsules administered once daily

Who Is Running the Clinical Trial?

Navitor Pharmaceuticals, Inc.

Lead Sponsor

Trials

4

Recruited

530+

Supernus Pharmaceuticals, Inc.

Industry Sponsor

Trials

49

Recruited

14,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6546442/

NV-5138 as a fast-acting antidepressant via direct ... With the authors having shown that ketamine induces a rapid antidepressant effect in treatment-resistant patients (4), the antidepressant effect of NV-5138 ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05066672

Phase 2 Study of NV-5138 in Adults With Treatment ... Change from baseline to end of treatment period on the Clinical Global Impression-Severity score for NV-5138 treated patients as compared to placebo.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6546461/

Sestrin modulator NV-5138 produces rapid antidepressant ... The results demonstrate that a single dose of NV-5138 produced rapid and long-lasting antidepressant effects and rapidly reversed anhedonia caused by chronic ...

4. americanpharmaceuticalreview.com americanpharmaceuticalreview.com/1315-News/351343-Navitor-Pharmaceuticals-Initiates-a-Clinical-Study-of-NV-5138/

Navitor Pharmaceuticals Initiates a Clinical Study of NV-5138 NV-5138 is initially being evaluated in TRD but may offer future potential for the treatment in the broader disease category of major depressive ...

5. withpower.com withpower.com/trial/phase-3-depressive-disorder-treatment-resistant-11-2021-442fc

NV-5138 for Treatment-Resistant Depression This trial is testing a new drug called NV-5138 to see if it can help adults whose depression hasn't improved with standard treatments. The drug works by ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38485588/

Advanced Model-based Approach to Evaluate Human ... Consecutive daily doses of NV-5138 were well tolerated in this healthy volunteer study. Keywords: NV-5138; Pharmacodynamics; Pharmacokinetic ...

7. firstwordpharma.com firstwordpharma.com/story/4730085

Navitor Pharmaceuticals Commences Phase 1 Clinical ... In Part B of the study, approximately 40 subjects diagnosed with TRD are being randomized to receive either a single dose of NV-5138 or placebo.

8. ir.supernus.com ir.supernus.com/news-releases/news-release-details/supernus-and-navitor-announce-development-and-option-agreement

Supernus and Navitor Announce Development and Option ... Phase I data demonstrated early proof of concept in which a single dose of NV-5138 showed rapid and sustained improvement in core symptoms of ...