Phase 3
Completed N=627
Safety of REL-1017 for Major Depressive Disorder
Source: ClinicalTrials.gov NCT04855760 ↗Enrolled (actual)
627
Serious AEs
1.3%
Results posted
Aug 2024
Primary outcomePrimary: Safety and Tolerability of REL-1017 as Incidence of Treatment Emergent Adverse Events (TEAEs) — 350 participants
◆ Published Evidence
Emerging
7citations · ~7 / year
Long-Term Safety and Efficacy of Esmethadone in Patients With Major Depressive Disorder: Findings From a 12-Month Open-Label Study.
Summary
This was a 1-year, multicenter, open-label, long-term study to assess the safety of REL-1017 once daily (QD) as monotherapy or as adjunctive treatment of Major Depressive Disorder. Adjunctive study participants continued to take their current antidepressant therapy in addition to the study drug for the duration of the treatment period.
Linked Publications
-
Long-Term Safety and Efficacy of Esmethadone in Patients With Major Depressive Disorder: Findings From a 12-Month Open-Label Study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety and Tolerability of REL-1017 as Incidence of Treatment Emergent Adverse Events (TEAEs) |
350 | — |
| SECONDARY Change in the QT Interval With Fridericia's Correction (QTcF) Interval From Baseline to Month 3 |
4.11 | — |
| SECONDARY Change in the QT Interval With Fridericia's Correction (QTcF) Interval From Baseline to Month 6 |
2.70 | — |
| SECONDARY Change in the QT Interval With Fridericia's Correction (QTcF) Interval From Baseline to Month 12 |
2.59 | — |
| SECONDARY Change in Diastolic Blood Pressure From Baseline to Month 3 |
0.5 | — |
| SECONDARY Change in Diastolic Blood Pressure From Baseline to Month 12 |
-0.2 | — |
| SECONDARY Change in Systolic Blood Pressure From Baseline to Month 3 |
0.4 | — |
| SECONDARY Change in Systolic Blood Pressure From Baseline to Month 12 |
0.0 | — |
| SECONDARY Change in Heart Rate From Baseline to Month 3 |
0.8 | — |
| SECONDARY Change in Heart Rate From Baseline to Month 12 |
-0.1 | — |
| SECONDARY Change in Weight From Baseline to Month 3 |
0.32 | — |
| SECONDARY Change in Weight From Baseline to Month 12 |
0.33 | — |
Eligibility Criteria
Inclusion Criteria
- Adults 18 to 65 years, inclusive.
- Diagnosed with Major Depressive Disorder (MDD) based on Structured Clinical Interview for DSM-5 (SCID-5) for MDD.
- Current major depressive episode.
Exclusion Criteria
- Any current and primary psychiatric disorder other than Major Depressive Disorder.
- History of bipolar I and II disorder, psychosis, and/or mania.
- Acute or chronic condition that, in the Investigator's opinion, would limit the subject's ability to complete or participate in this clinical study.
Data sourced from ClinicalTrials.gov (NCT04855760) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.