NV-5138 for Treatment-Resistant Depression
What You Need to Know Before You Apply
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.
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
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive NV-5138 or placebo once daily for 5 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- matched placebo
- NV-5138
Find a Clinic Near You
Who Is Running the Clinical Trial?
Navitor Pharmaceuticals, Inc.
Lead Sponsor
Supernus Pharmaceuticals, Inc.
Industry Sponsor