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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 is a Phase 2 study that has completed, run by Relmada Therapeutics. The registered enrollment target is 62 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03051256
The ClinicalTrials.gov registry entry for NCT03051256 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 62 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Relmada Therapeutics, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03051256 reports 0 study locations.
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.
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