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

Completed · Phase 3

Conditions studied: Major Depressive Disorder, Treatment Resistant Depression, Depression

In brief

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

Key facts

Study ID

NCT04039022

Run by

Axsome Therapeutics, Inc.

People needed

876

Starts

2019-07-08

Expected to finish

2020-10-23

Last updated by the study team

2022-10-12

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Suicide risk
• Pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study
• Additional criteria may apply

Where it is running

• Clinical Research Site — Little Rock, Arkansas, United States
• Clinical Research Site — Bellflower, California, United States
• Clinical Research Site — Beverly Hills, California, United States
• Clinical Research Site — Culver City, California, United States
• Clinical Research Site — Garden Grove, California, United States
• Clinical Research Site — Oakland, California, United States
• Clinical Research Site — Oceanside, California, United States
• Clinical Research Site — Panorama City, California, United States
• Clinical Research Site — Redlands, California, United States
• Clinical Research Site — San Diego, California, United States
• Clinical Research Site — Sherman Oaks, California, United States
• Clinical Research Site — Upland, California, United States
• Clinical Research Site — Cromwell, Connecticut, United States
• Clinical Research Site — Coral Springs, Florida, United States
• Clinical Research Site — Hialeah, Florida, United States
• Clinical Research Site — Hollywood, Florida, United States
• Clinical Research Site — Jacksonville, Florida, United States
• Clinical Research Site — Lauderhill, Florida, United States
• Clinical Research Site — Miami, Florida, United States
• Clinical Research Site — North Miami, Florida, United States
• Clinical Research Site — Orlando, Florida, United States
• Clinical Research Site — Atlanta, Georgia, United States
• Clinical Research Site — Atlanta, Georgia, United States
• Clinical Research Site — Boise, Idaho, United States
• Clinical Research Site — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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