Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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.
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)
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03606395
The ClinicalTrials.gov registry entry for NCT03606395 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 372-participant average among 54 other Treatment-Resistant Depression trials with a reported enrollment target (78% lower). The listed sponsor is Navitor Pharmaceuticals, which has 3 total studies on file at ClinicalTrials.gov.
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 reports 9 study locations spanning 6 distinct geographic areas - top geographies include 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.
-
DBS for Depression
RECRUITING · Phase 1
-
Slow Wave Induction by Propofol to Eliminate Depression (SWIPED) I
ACTIVE NOT RECRUITING · Phase 1
-
Multiple Ascending Dose Phase 1 Study of ALA-3000
COMPLETED · Phase 1
-
Home-administered tDCS for Treatment of Depression
COMPLETED · Phase 1
-
Ultrasound Neuromodulation of Circuits and Negative Valence Systems in Treatment-Resistant Depression
RECRUITING · NA
-
A Study to Assess the Efficacy, Safety and Tolerability of VLS-01 Buccal Film, Compared to Placebo in Patients With Treatment Resistant Depression (ELUMINA)
RECRUITING · Phase 2
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.