Safety, Tolerability, PK Profile, and Symptom Response of a 7-Day Dosing With 25 mg or 50 mg Daily of REL-1017 in MDD
Public ClinicalTrials.gov record NCT03051256. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Phase 2a Multicenter Randomized Double-Blind Placebo-Controlled Study to Assess the Safety, Tolerability, PK Profile, and Symptom Response of a 7-Day Dosing of REL-1017 as Adjunctive Therapy in the Treatment of Pts Diagnosed With MDD
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03051256
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 62 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 11, 2018 (Actual)
- Primary completion
- Jul 30, 2019 (Actual)
- Completion
- Sep 30, 2019 (Actual)
- Last update posted
- Nov 1, 2023
2018 – 2019
United States locations
- U.S. sites
- 10
- U.S. states
- 8
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Woodland International Research Group | Little Rock | Arkansas | 72211 | — |
| Collaborative Neuroscience Network, LLC | Garden Grove | California | 92845-2506 | — |
| Artemis Institute for Clinical Research | San Diego | California | 92103 | — |
| Innovative Clinical Research, Inc | Hialeah | Florida | 33012 | — |
| Atlanta Center for Medical Research | Atlanta | Georgia | 30331 | — |
| iResearch Atlanta, LLC | Decatur | Georgia | 30030 | — |
| St. Louis Clinical Trials, LLC | St Louis | Missouri | 63141 | — |
| Hassman Research Institute | Berlin | New Jersey | 08009 | — |
| Midwest Clinical Research Center | Dayton | Ohio | 45417-3445 | — |
| Pillar Clinical Research, LLC | Richardson | Texas | 75080 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03051256, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 1, 2023 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03051256 live on ClinicalTrials.gov.