Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05081167 | A Study to Assess the Efficacy and Safety of REL-1017 as Monotherapy for Major Depressive Disorder (MDD) | PHASE3 | COMPLETED | 232 | — | — | Jun 2, 2021 | Sep 14, 2022 | Mar 26, 2024 | 10 | United States |
| NCT04855760 | Safety of REL-1017 for Major Depressive Disorder | PHASE3 | COMPLETED | 627 | — | — | Apr 1, 2021 | Jul 27, 2023 | Feb 11, 2025 | 9 | United States |
| NCT04688164 | A Study to Assess the Efficacy and Safety of REL-1017 as Adjunctive Treatment for Major Depressive Disorder (MDD) | PHASE3 | COMPLETED | 227 | — | — | Jan 8, 2021 | Nov 10, 2022 | Aug 27, 2024 | 11 | United States |
Therapeutic efficacy of REL-1017 as monotherapy versus placebo in the Montgomery-Asberg Depression Rating Scale (MADRS10). A higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60 with scores above 34 indicating severe depression. A negative change from baseline indicates improvement.
Subjects with at least one Treatment Emergent Adverse Events (TEAEs)
| Arm | Type | Description |
|---|---|---|
| REL-1017 | EXPERIMENTAL | A 75 mg REL-1017 loading dose (three 25 mg REL-1017 tablets) will be administered on Day-1 of the 28-day treatment period. From Day-2 to Day-28, participants will take 25 mg REL-1017. |
| Placebo | PLACEBO_COMPARATOR | Three tablets of matching placebo will be administered on Day-1 of the 28-day treatment period. From Day-2 to Day-28, participants will take 1 placebo tablet. |
| Name | Type | Description |
|---|---|---|
| REL-1017 | DRUG | REL-1017 tablet |
| Placebo | DRUG | Placebo tablet |
Inclusion Criteria: * Adults 18 to 65 years, inclusive. * Diagnosed with Major Depressive Disorder (MDD) based on Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, DSM-5 (SCID-5) for MDD. * Current major depressive episode. Exclusion Criteria: * Any current ...