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NV-5138 for Treatment-Resistant Depression

Phase 2
Recruiting
Research Sponsored by Navitor Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
History of inadequate response to ≥2 but ≤4 prior ADT therapies (including the current ADT for the current MDE) ≥ 2 weeks at Screening and ≥ 8 weeks at Baseline.
18-70 years old?
Must not have
You have been diagnosed with Psychosis
You have been diagnosed with Bipolar Disorder
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 weeks
Awards & highlights

Study Summary

This trial will test if NV-5138 is safe and effective in adults with Treatment-Resistant Depression.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Specific side effects for NV-5138 are not listed here, but common side effects for new depression treatments may include nausea, headache, dizziness, fatigue, changes in appetite or weight, sleep disturbances and mood swings.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I've tried 2-4 ADT therapies for my condition without success.
Select...
I have been on a stable dose of my depression medication for at least 2 weeks.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Evaluation of the efficacy of NV-5138 as measured by the Montgomery-Asberg Depression Rating scale
Secondary outcome measures
Evaluation of the efficacy as measured by Clinical Global Impression-Severity (CGI-s) score

Trial Design

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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
NV-5138
2018
Completed Phase 1
~80

Find a Location

Who is running the clinical trial?

Navitor Pharmaceuticals, Inc.Lead Sponsor
3 Previous Clinical Trials
136 Total Patients Enrolled
Supernus Pharmaceuticals, Inc.Industry Sponsor
47 Previous Clinical Trials
13,398 Total Patients Enrolled
Randy Owen, MDStudy DirectorMedical Monitor

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the Food and Drug Administration greenlit NV-5138 for public consumption?

"According to our team at Power, NV-5138 was rated a 2 on the safety scale since it is currently undergoing Phase 2 trials. This implies that there has been some evidence of safety but no data regarding its efficacy yet."

Answered by AI

Does the research permit participation from those who are more than thirty years of age?

"Inclusion criteria for this medical trial necessitates that all participants are aged between 18 and 70 years old."

Answered by AI

How many participants are included in this investigation?

"Affirmative. According to the information on clinicaltrials.gov, this study is currently enrolling individuals; its initial post-date was February 28th 2022 and it has since been amended on March 9th 2022. The investigation entails recruiting 400 patients from a single location."

Answered by AI

Is this clinical trial actively seeking participants at the present time?

"Affirmative, the information hosted on clinicaltrials.gov states that this experiment is presently inviting patients to join. It was initially advertised on February 28th 2022 and most recently revised March 9th 2022. 400 participants need to be recruited across 1 clinic location."

Answered by AI

Am I eligible to partake in this research initiative?

"For eligibility, applicants must be suffering from depression and between 18-70 years old. Approximately 400 individuals will be admitted to the trial in total."

Answered by AI

Who else is applying?

What state do they live in?
Washington
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
Northwest Clinical Research Center, Inc.
Woodstock Research Center
Recent research and studies
clinicaltrials.govStudy
Phase 2 Study of NV-5138 in Adults With Treatment Resistant Depression
2022. "Phase 2 Study of NV-5138 in Adults With Treatment Resistant Depression". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05066672.
~85 spots leftby Dec 2024
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