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NCT03606395 · ClinicalTrials.gov registry record · Phase 1
Safety, Tolerability, PK and Efficacy of Single Doses of NV-5138 in Healthy Volunteers and Subjects With Treatment-Resistant Depression
A Phase 1 study of Treatment-Resistant Depression, sponsored by Navitor Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 80
- Enrollment target
- 9
- Study locations
NCT03606395: Completed Phase 1 study of Treatment-Resistant Depression, sponsored by Navitor Pharmaceuticals.
NCT03606395 is a Phase 1 study of Treatment-Resistant Depression that has completed, run by Navitor Pharmaceuticals. The registered enrollment target is 80 participants, below the 372-participant average among 54 other Treatment-Resistant Depression trials with a reported enrollment target (78% lower). The trial reports 9 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03606395, a Phase 1 study of Treatment-Resistant Depression, has completed, sponsored by Navitor Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 80 participants
- Enrollment target
- 9
- Study locations
Study Summary
Randomized, two-part, placebo-controlled study of single ascending doses of NV-5138 in healthy volunteers, and a single dose of NV-5138 in subjects with Treatment-Resistant Depression (TRD)
Primary Outcome
Number of subjects with treatment emergent adverse events
Conditions Studied
Interventions
- DRUG Placebos
- DRUG NV-5138
Study Locations (9)
Florida
- MD Clinical - Hallandale
- Innovative Clinical Research Inc - Hialeah
- Research Centers of America - Hollywood
California
- Collaborative Neuroscience Network - Long Beach
- Synergy San Diego - San Diego
Alabama
- University of Alabama at Birmingham - Birmingham
Missouri
- St. Louis Clinical Trials - St Louis
New Jersey
- Hassman Research Institute - Berlin
Ohio
- Midwest Clinical Research - Dayton
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2018-06-06 |
| Est. Completion | 2019-07-07 |
| Phase | Phase 1 |
What the finished NCT03606395 record still lists
NCT03606395 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 372-participant average among 54 other Treatment-Resistant Depression trials with a reported enrollment target (78% lower).
The record links to 1 condition, with Treatment-Resistant Depression appearing as the primary indexed condition, and to 2 interventions - of which Placebos is the first listed.
NCT03606395 lists 9 locations in 6 states (Florida, California, Alabama).
Frequently Asked Questions
What is clinical trial NCT03606395 about?
NCT03606395 is a clinical study titled "Safety, Tolerability, PK and Efficacy of Single Doses of NV-5138 in Healthy Volunteers and Subjects With Treatment-Resistant Depression". Randomized, two-part, placebo-controlled study of single ascending doses of NV-5138 in healthy volunteers, and a single dose of NV-5138 in subjects with Treatment-Resistant Depression (TRD)
What is the current status of trial NCT03606395?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 80 participants. The study started on 2018-06-06. Estimated completion is 2019-07-07.
What conditions does trial NCT03606395 study?
This clinical trial studies the following conditions: Treatment-Resistant Depression.
What interventions are being tested in trial NCT03606395?
The interventions under investigation include: Placebos (DRUG), NV-5138 (DRUG).
Who is sponsoring clinical trial NCT03606395?
This trial is sponsored by Navitor Pharmaceuticals, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03606395 being conducted?
This trial has 9 study locations across Alabama, California, Florida, Missouri, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Treatment-Resistant Depression
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03606395's enrollment target sits among peer trials
80 21st of 54 higher than 33 of 54 other Treatment-Resistant Depression trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Treatment-Resistant Depression trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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