NV-5138 for Treatment-Resistant Depression
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
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
Exclusion Criteria
Timeline
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
Treatment Details
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