At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 327 enrolled
Drug / intervention
AXS-05 +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.
AXS-05-MDD-301: A Randomized, Double-Blind, Placebo-Controlled Trial of AXS-05 in Subjects With Major Depressive Disorder
In Brief
A Phase 3 clinical trial evaluating AXS-05 and Placebo for Depression and Major Depressive Disorder. Completed, enrolled 327 participants across 43 sites.
Detailed Summary
A Phase 3, randomized, double-blind, placebo-controlled, multicenter trial of AXS-05 in patients with major depressive disorder (MDD).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDepression, Major Depressive Disorder
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
2020202120222023202420252026
Enrollment StartJun 2019
First PostedJul 2019
Primary CompletionNov 2019
Study CompletionDec 2019
TodayJul 2026
First PostedJul 15, 2019
Enrollment StartJun 20, 2019
Primary CompletionNov 26, 2019
Study CompletionDec 5, 2019
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 7.0 years ago
Interventions
AXS-05drug
Oral AXS-05 tablets, taken daily for 6 weeks.
Placebodrug
Placebo to match oral AXS-05 tablets, taken daily for 6 weeks.