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To evaluate the relapse prevention of AXS-05 relative to placebo in subjects with treatment resistant depression (TRD).
This is a randomized, double-blind, placebo-controlled study to evaluate AXS-05 compared to placebo in delaying relapse of depressive symptoms in patients with TRD who are in stable remission after treatment with AXS-05.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AXS-05 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AXS-05 | Drug | AXS-05 taken daily for up to 52 weeks, until relapse. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Relapse | Assessed by clinician-rated scales. | Time from randomization to first relapse (up to 52 weeks) |
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Key Eligibility Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Site | Little Rock | Arkansas | 72209 | United States | ||
| Clinical Research Site |
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| Label | URL |
|---|---|
| Axsome Therapeutics Website | View source |
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Double (Participant, Investigator)
| Placebo |
| Drug |
Placebo taken daily for up to 52 weeks, until relapse. |
|
| Redlands |
| California |
| 92374 |
| United States |
| Clinical Research Site | Sherman Oaks | California | 91403 | United States |
| Clinical Research Site | Upland | California | 91786 | 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 | Chicago | Illinois | 606346 | United States |
| Clinical Research Site | Boston | Massachusetts | 02131 | United States |
| Clinical Research Site | Berlin | New Jersey | 08009 | 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 | Middleburg Heights | Ohio | 44130 | United States |
| Clinical Research Site | Media | Pennsylvania | 19063 | United States |
| Clinical Research Site | Dallas | Texas | 75243 | United States |
| Clinical Research Site | Houston | Texas | 77058 | United States |
| Clinical Research Site | Everett | Washington | 98201 | United States |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 8, 2024 | Jul 30, 2024 | 4 | ||
| Dec 31, 2025 | Jan 20, 2026 | 5 |
| ID | Term |
|---|---|
| D061218 | Depressive Disorder, Treatment-Resistant |
| D003865 | Depressive Disorder, Major |
| D003863 | Depression |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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