At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 227 enrolled
Drug / intervention
REL-1017 +1 moredrug
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, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of REL-1017 as Adjunctive Treatment of Major Depressive Disorder (The RELIANCE-I Study)
In Brief
A Phase 3 clinical trial evaluating REL-1017 and Placebo for Major Depressive Disorder. Completed, enrolled 227 participants across 11 sites.
Detailed Summary
This is an outpatient, 2-arm, Phase 3, multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of REL-1017 once daily (QD) as an adjunctive treatment of Major Depressive Disorder. Study participants will continue to take their current antidepressant therapy in addition to the study drug or placebo for the duration of the treatment period.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMajor Depressive Disorder
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
202120222023202420252026
First PostedDec 2020
Enrollment StartJan 2021
Primary CompletionNov 2022
Study CompletionNov 2022
TodayJul 2026
First PostedDec 29, 2020
Enrollment StartJan 8, 2021
Primary CompletionNov 1, 2022
Study CompletionNov 10, 2022
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 5.5 years ago
Interventions
REL-1017drug
REL-1017 tablet
Placebodrug
Placebo tablet