Open-Label Safety Study of AXS-05 in Subjects With Depression

• Status: Completed
• Trial end date: 2020-10-23
• Target enrollment: 0
• Participant gender: All

Summary

An open-label, long-term, safety study of AXS-05 in patients with major depressive disorder (MDD), including treatment resistant depression.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Axsome Therapeutics, Inc.
• Treatments: Bupropion; Dextromethorphan

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