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NCT03051256 · ClinicalTrials.gov registry record · Phase 2
Safety, Tolerability, PK Profile, and Symptom Response of a 7-Day Dosing With 25 mg or 50 mg Daily of REL-1017 in MDD
A Phase 2 study, sponsored by Relmada Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 62
- Enrollment target
NCT03051256: Completed Phase 2 study, sponsored by Relmada Therapeutics.
NCT03051256 is a Phase 2 study that has completed, run by Relmada Therapeutics. The registered enrollment target is 62 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03051256, a Phase 2 study, has completed, sponsored by Relmada Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 62 participants
- Enrollment target
Study Summary
This a Phase 2a, multicenter, randomized, double-blind, placebo controlled 3 arm study to assess the safety and tolerability of multiple oral doses of REL-1017 25 mg and 50 mg as adjunctive therapy in the treatment of patients diagnosed with major depressive disorder (MDD). The patients will be adults with MDD who are diagnosed with a current MDE who have experienced an inadequate response to 1 to 3 courses of treatment with an antidepressant medication. This population will provide the opportunity to compare the safety and efficacy effects of treatment with an approved antidepressant in conjunction with REL-1017 versus the effects of an antidepressant alone. This study includes in-patient and out-patient periods.
Primary Outcome
Spontaneously reported or observed AEs will be recorded and reported throughout the study, and AEs will be elicited using a non-leading question at every visit from Screening through the Day 21 assessment. An AE was any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and may not necessarily have a causal relationship with the administered treatment. An AE could therefore be any unfavorable and unintended sign (including a clinical
Interventions
- DRUG Placebo
- DRUG REL-1017
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 62 participants |
| Start Date | 2018-05-11 |
| Est. Completion | 2019-09-30 |
| Phase | Phase 2 |
What the finished NCT03051256 record still lists
NCT03051256 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 62 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (53% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03051256 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03051256 about?
NCT03051256 is a clinical study titled "Safety, Tolerability, PK Profile, and Symptom Response of a 7-Day Dosing With 25 mg or 50 mg Daily of REL-1017 in MDD". This a Phase 2a, multicenter, randomized, double-blind, placebo controlled 3 arm study to assess the safety and tolerability of multiple oral doses of REL-1017 25 mg and 50 mg as adjunctive therapy in the treatment of patients diagnosed with major depressive disorder (MDD). The patients will be adul...
What is the current status of trial NCT03051256?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 62 participants. The study started on 2018-05-11. Estimated completion is 2019-09-30.
What interventions are being tested in trial NCT03051256?
The interventions under investigation include: Placebo (DRUG), REL-1017 (DRUG).
Who is sponsoring clinical trial NCT03051256?
This trial is sponsored by Relmada Therapeutics, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03051256's enrollment target sits among peer trials
62 1016th of 2000 higher than 975 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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