Open-Label Safety Study of AXS-05 in Subjects With Depression
Phase 3
Completed
- Conditions
- Major Depressive DisorderTreatment Resistant DepressionDepression
- Interventions
- Drug: AXS-05 (dextromethorphan and bupropion) oral tablets
- Registration Number
- NCT04039022
- Lead Sponsor
- Axsome Therapeutics, Inc.
- Brief Summary
An open-label, long-term, safety study of AXS-05 in patients with major depressive disorder (MDD), including treatment resistant depression.
- Detailed Description
A multi-center, open-label, long-term study to evaluate the safety and efficacy of AXS-05 in patients with major depressive disorder, including treatment resistant depression, treated for up to one year.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 876
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description AXS-05 AXS-05 (dextromethorphan and bupropion) oral tablets -
- Primary Outcome Measures
Name Time Method Incidence of Treatment-emergent AEs (TEAEs) Following Dosing With AXS-05 Up to 12 months Types and rates of adverse events
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Clinical Research Site
🇺🇸Everett, Washington, United States