Open-Label Safety Study of AXS-05 in Subjects With Depression
Sponsor
Axsome Therapeutics, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT04039022
Collaborator
(none)
876
51
1
15.5
17.2
1.1
Study Details
Study Description
Brief Summary
An open-label, long-term, safety study of AXS-05 in patients with major depressive disorder (MDD), including treatment resistant depression.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
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.
Study Design
Study Type:
Interventional
Actual Enrollment
:
876 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open-Label Study to Assess the Long-term Safety and Efficacy of AXS-05 in Subjects With Major Depressive Disorder
Actual Study Start Date
:
Jul 8, 2019
Actual Primary Completion Date
:
Oct 23, 2020
Actual Study Completion Date
:
Oct 23, 2020
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: AXS-05 (dextromethorphan and bupropion)
|
Drug: AXS-05
Oral tablets, taken twice daily for up to 12 months.
|
Outcome Measures
Primary Outcome Measures
- Types and rates of adverse events [Up to 12 months]
Safety
Other Outcome Measures
- Montgomery-Åsberg Depression Rating Scale (MADRS) [Up to 12 months]
The MADRS is a clinician-rated scale designed to measure depression severity and detects changes due to antidepressant treatment. The scale consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score of 60. Higher scores represent a more severe condition.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Clinical Research Site | Phoenix | Arizona | United States | 85012 |
| 2 | Clinical Research Site | Little Rock | Arkansas | United States | 72209 |
| 3 | Clinical Research Site | Bellflower | California | United States | 90706 |
| 4 | Clinical Research Site | Beverly Hills | California | United States | 90210 |
| 5 | Clinical Research Site | Culver City | California | United States | 90230 |
| 6 | Clinical Research Site | Garden Grove | California | United States | 92845 |
| 7 | Clinical Research Site | Oakland | California | United States | 94607 |
| 8 | Clinical Research Site | Oceanside | California | United States | 92056 |
| 9 | Clinical Research Site | Panorama City | California | United States | 91402 |
| 10 | Clinical Research Site | Redlands | California | United States | 92374 |
| 11 | Clinical Research Site | San Diego | California | United States | 92103 |
| 12 | Clinical Research Site | Sherman Oaks | California | United States | 91403 |
| 13 | Clinical Research Site | Upland | California | United States | 91786 |
| 14 | Clinical Research Site | Cromwell | Connecticut | United States | 06416 |
| 15 | Clinical Research Site | Coral Springs | Florida | United States | 33067 |
| 16 | Clinical Research Site | Hialeah | Florida | United States | 33012 |
| 17 | Clinical Research Site | Hollywood | Florida | United States | 33024 |
| 18 | Clinical Research Site | Jacksonville | Florida | United States | 32256 |
| 19 | Clinical Research Site | Lauderhill | Florida | United States | 33319 |
| 20 | Clinical Research Site | Miami | Florida | United States | 33122 |
| 21 | Clinical Research Site | North Miami | Florida | United States | 33161 |
| 22 | Clinical Research Site | Orlando | Florida | United States | 32801 |
| 23 | Clinical Research Site | Atlanta | Georgia | United States | 30328 |
| 24 | Clinical Research Site | Atlanta | Georgia | United States | 30331 |
| 25 | Clinical Research Site | Boise | Idaho | United States | 83704 |
| 26 | Clinical Research Site | Chicago | Illinois | United States | 60634 |
| 27 | Clinical Research Site | Boston | Massachusetts | United States | 02131 |
| 28 | Clinical Research Site | Las Vegas | Nevada | United States | 89102 |
| 29 | Clinical Research Site | Berlin | New Jersey | United States | 08009 |
| 30 | Clinical Research Site | Cherry Hill | New Jersey | United States | 08002 |
| 31 | Clinical Research Site | Toms River | New Jersey | United States | 08755 |
| 32 | Clinical Research Site | Jamaica | New York | United States | 11432 |
| 33 | Clinical Research Site | Rochester | New York | United States | 14618 |
| 34 | Clinical Research Site | Staten Island | New York | United States | 10312 |
| 35 | Clinical Research Site | Hickory | North Carolina | United States | 28601 |
| 36 | Clinical Research Site | Raleigh | North Carolina | United States | 27609 |
| 37 | Clinical Research Site | Cincinnati | Ohio | United States | 45215 |
| 38 | Clinical Research Site | Cincinnati | Ohio | United States | 45219 |
| 39 | Clinical Research Site | Middleburg Heights | Ohio | United States | 44130 |
| 40 | Clinical Research Site | Oklahoma City | Oklahoma | United States | 73112 |
| 41 | Clinical Research Site | Media | Pennsylvania | United States | 19063 |
| 42 | Clinical Research Site | Philadelphia | Pennsylvania | United States | 19104 |
| 43 | Clinical Research Site | Memphis | Tennessee | United States | 38119 |
| 44 | Clinical Research Site | Austin | Texas | United States | 78712 |
| 45 | Clinical Research Site | Dallas | Texas | United States | 75243 |
| 46 | Clinical Research Site | Fort Worth | Texas | United States | 76104 |
| 47 | Clinical Research Site | Houston | Texas | United States | 77058 |
| 48 | Clinical Research Site | San Antonio | Texas | United States | 78229 |
| 49 | Clinical Research Site | Wichita Falls | Texas | United States | 76309 |
| 50 | Clinical Research Site | Bellevue | Washington | United States | 98007 |
| 51 | Clinical Research Site | Everett | Washington | United States | 98201 |
Sponsors and Collaborators
- Axsome Therapeutics, Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Axsome Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT04039022
Other Study ID Numbers:
- AXS-05-303
First Posted:
Jul 31, 2019
Last Update Posted:
Oct 20, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Axsome Therapeutics, Inc.
Additional relevant MeSH terms: