Open-Label Safety Study of AXS-05 in Subjects With Depression
An Open-Label Study to Assess the Long-term Safety and Efficacy of AXS-05 in Subjects With Major Depressive Disorder
1 other identifier
interventional
876
1 country
51
Brief Summary
An open-label, long-term, safety study of AXS-05 in patients with major depressive disorder (MDD), including treatment resistant depression.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 major-depressive-disorder
Started Jul 2019
51 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 8, 2019
CompletedFirst Submitted
Initial submission to the registry
July 29, 2019
CompletedFirst Posted
Study publicly available on registry
July 31, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 23, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 23, 2020
CompletedResults Posted
Study results publicly available
October 12, 2022
CompletedOctober 12, 2022
September 1, 2022
1.3 years
July 29, 2019
September 16, 2022
September 16, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of Treatment-emergent AEs (TEAEs) Following Dosing With AXS-05
Types and rates of adverse events
Up to 12 months
Study Arms (1)
AXS-05
EXPERIMENTALInterventions
Oral tablets, taken twice daily for up to 12 months.
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (51)
Clinical Research Site
Phoenix, Arizona, 85012, United States
Clinical Research Site
Little Rock, Arkansas, 72209, United States
Clinical Research Site
Bellflower, California, 90706, United States
Clinical Research Site
Beverly Hills, California, 90210, United States
Clinical Research Site
Culver City, California, 90230, United States
Clinical Research Site
Garden Grove, California, 92845, United States
Clinical Research Site
Oakland, California, 94607, United States
Clinical Research Site
Oceanside, California, 92056, United States
Clinical Research Site
Panorama City, California, 91402, United States
Clinical Research Site
Redlands, California, 92374, United States
Clinical Research Site
San Diego, California, 92103, United States
Clinical Research Site
Sherman Oaks, California, 91403, United States
Clinical Research Site
Upland, California, 91786, United States
Clinical Research Site
Cromwell, Connecticut, 06416, United States
Clinical Research Site
Coral Springs, Florida, 33067, United States
Clinical Research Site
Hialeah, Florida, 33012, United States
Clinical Research Site
Hollywood, Florida, 33024, United States
Clinical Research Site
Jacksonville, Florida, 32256, United States
Clinical Research Site
Lauderhill, Florida, 33319, United States
Clinical Research Site
Miami, Florida, 33122, United States
Clinical Research Site
North Miami, Florida, 33161, United States
Clinical Research Site
Orlando, Florida, 32801, United States
Clinical Research Site
Atlanta, Georgia, 30328, United States
Clinical Research Site
Atlanta, Georgia, 30331, United States
Clinical Research Site
Boise, Idaho, 83704, United States
Clinical Research Site
Chicago, Illinois, 60634, United States
Clinical Research Site
Boston, Massachusetts, 02131, United States
Clinical Research Site
Las Vegas, Nevada, 89102, United States
Clinical Research Site
Berlin, New Jersey, 08009, United States
Clinical Research Site
Cherry Hill, New Jersey, 08002, United States
Clinical Research Site
Toms River, New Jersey, 08755, United States
Clinical Research Site
Jamaica, New York, 11432, United States
Clinical Research Site
Rochester, New York, 14618, United States
Clinical Research Site
Staten Island, New York, 10312, United States
Clinical Research Site
Hickory, North Carolina, 28601, United States
Clinical Research Site
Raleigh, North Carolina, 27609, United States
Clinical Research Site
Cincinnati, Ohio, 45215, United States
Clinical Research Site
Cincinnati, Ohio, 45219, United States
Clinical Research Site
Middleburg Heights, Ohio, 44130, United States
Clinical Research Site
Oklahoma City, Oklahoma, 73112, United States
Clinical Research Site
Media, Pennsylvania, 19063, United States
Clinical Research Site
Philadelphia, Pennsylvania, 19104, United States
Clinical Research Site
Memphis, Tennessee, 38119, United States
Clinical Research Site
Austin, Texas, 78712, United States
Clinical Research Site
Dallas, Texas, 75243, United States
Clinical Research Site
Fort Worth, Texas, 76104, United States
Clinical Research Site
Houston, Texas, 77058, United States
Clinical Research Site
San Antonio, Texas, 78229, United States
Clinical Research Site
Wichita Falls, Texas, 76309, United States
Clinical Research Site
Bellevue, Washington, 98007, United States
Clinical Research Site
Everett, Washington, 98201, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Caroline Streicher, Senior Director, Clinical Operations
- Organization
- Axsome Therapeutics, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 29, 2019
First Posted
July 31, 2019
Study Start
July 8, 2019
Primary Completion
October 23, 2020
Study Completion
October 23, 2020
Last Updated
October 12, 2022
Results First Posted
October 12, 2022
Record last verified: 2022-09
Data Sharing
- IPD Sharing
- Will not share