At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 627 enrolled
Drug / intervention
REL-1017drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3, Multicenter, Open-Label Study to Assess the Long-Term Safety of REL-1017 as a Treatment of Major Depressive Disorder
In Brief
A Phase 3 clinical trial evaluating REL-1017 for Major Depressive Disorder. Completed, enrolled 627 participants across 9 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMajor Depressive Disorder
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20222023202420252026
Enrollment StartApr 2021
First PostedApr 2021
Primary CompletionJul 2023
TodayJul 2026
First PostedApr 22, 2021
Enrollment StartApr 1, 2021
Primary CompletionJul 27, 2023
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 5.2 years ago
Interventions
REL-1017drug
REL-1017 tablet