400 Participants Needed

NV-5138 for Treatment-Resistant Depression

Recruiting at 1 trial location
JF
JE
SG
MG
CK
JP
SM
WO
Overseen ByWelton Oneal
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Navitor Pharmaceuticals, Inc.
Must be taking: Antidepressants
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

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.

How is the drug NV-5138 different from other treatments for treatment-resistant depression?

The drug NV-5138 is unique because it may work through a different mechanism than traditional antidepressants, potentially targeting brain pathways involved in mood regulation that are not addressed by existing treatments. This could offer a new option for patients who do not respond to current medications.12345

What is the purpose of this trial?

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 changing brain chemicals to improve mood.

Research Team

RO

Randy Owen, MD

Principal Investigator

Medical Monitor

Eligibility Criteria

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
See 3 more

Timeline

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

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: NV-5138 400 mg oral capsulesExperimental Treatment1 Intervention
Either 2 or 4 400 mg oral capsules administered once daily
Group II: matched placeboPlacebo Group1 Intervention
2 or 4 oral capsules administered once daily

Find a Clinic Near You

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+

References

Efficacy and Safety of Fixed-Dose Esketamine Nasal Spray Combined With a New Oral Antidepressant in Treatment-Resistant Depression: Results of a Randomized, Double-Blind, Active-Controlled Study (TRANSFORM-1). [2020]
2.Russia (Federation)pubmed.ncbi.nlm.nih.gov
[Treatment of drug-resistant depression by intravenous administration of antidepressants]. [2013]
[Treatment resistant depression: Challenges and therapeutic choices]. [2022]
Limbic system white matter microstructure and long-term treatment outcome in major depressive disorder: a diffusion tensor imaging study using legacy data. [2022]
Treatment-resistant depression: definition, prevalence, detection, management, and investigational interventions. [2023]
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