Phase 3
N=627
Safety of REL-1017 for Major Depressive Disorder
Major Depressive Disorder
Bottom Line
View on ClinicalTrials.gov: NCT04855760 ↗Enrolled (actual)
627
Serious AEs
1.3%
Results posted
Aug 2024
Primary outcome: Primary: Safety and Tolerability of REL-1017 as Incidence of Treatment Emergent Adverse Events (TEAEs) — 350 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- REL-1017 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Relmada Therapeutics, Inc.
- Primary completion
- Jul 2023
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 | — |
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.
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). 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.