At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 876 enrolled
Drug / intervention
AXS-05 (dextromethorphan and bupropion) oral tabletsdrug
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.
An Open-Label Study to Assess the Long-term Safety and Efficacy of AXS-05 in Subjects With Major Depressive Disorder
In Brief
A Phase 3 clinical trial evaluating AXS-05 (dextromethorphan and bupropion) oral tablets for Major Depressive Disorder and 2 related conditions. Completed, enrolled 876 participants across 51 sites.
Detailed Summary
An open-label, long-term, safety study of AXS-05 in patients with major depressive disorder (MDD), including treatment resistant depression.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
2020202120222023202420252026
Enrollment StartJul 2019
First PostedJul 2019
Primary CompletionOct 2020
TodayJul 2026
First PostedJul 31, 2019
Enrollment StartJul 8, 2019
Primary CompletionOct 23, 2020
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 6.9 years ago
Interventions
AXS-05 (dextromethorphan and bupropion) oral tabletsdrug
Oral tablets, taken twice daily for up to 12 months.