Phase 3
Completed N=876
Open-Label Safety Study of AXS-05 in Subjects With Depression
Source: ClinicalTrials.gov NCT04039022 ↗Enrolled (actual)
876
Serious AEs
2.4%
Results posted
Oct 2022
Primary outcomePrimary: Incidence of Treatment-emergent AEs (TEAEs) Following Dosing With AXS-05 — 505 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
An open-label, long-term, safety study of AXS-05 in patients with major depressive disorder (MDD), including treatment resistant depression.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Treatment-emergent AEs (TEAEs) Following Dosing With AXS-05 |
505 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of major depressive disorder, including treatment resistant depression
- Body mass index (BMI) between 18 and 40 kg/m^2, inclusive
- Agree to use adequate method of contraception for the duration of the study
- Additional criteria may apply
Exclusion Criteria
- Suicide risk
- Pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study
- Additional criteria may apply
Data sourced from ClinicalTrials.gov (NCT04039022). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.