Major Depressive Disorder Clinical Trial
— ASCENDOfficial title:
A Randomized, Double-Blind, Active-Controlled Trial of AXS-05 Administered Orally to Subjects With Major Depressive Disorder
Verified date | September 2021 |
Source | Axsome Therapeutics, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Randomized, Double-Blind, Active-Controlled Study of AXS-05 for MDD.
Status | Completed |
Enrollment | 97 |
Est. completion date | January 7, 2019 |
Est. primary completion date | January 7, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - Currently meets DSM-5 criteria for MDD - 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 - History of treatment resistance in current depressive episode - History of electroconvulsive therapy, vagus nerve stimulation, transcranial magnetic stimulation or any experimental central nervous system treatment during the current episode or in the past 6 months - Pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study - Additional criteria may apply |
Country | Name | City | State |
---|---|---|---|
United States | Clinical Research Site | Bellevue | Washington |
United States | Clinical Research Site | Beverly Hills | California |
United States | Clinical Research Site | Jacksonville | Florida |
United States | Clinical Research Site | Orlando | Florida |
Lead Sponsor | Collaborator |
---|---|
Axsome Therapeutics, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | MADRS Score - Change From Baseline to Week 6 | The primary objective of the study was to assess the effect of AXS-05 versus bupropion as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS) for change in severity of depressive symptoms. The MADRS is a 10-item scale and items are scored between 0-6 points. For each item, a score of 0 indicates the absence of symptoms, and a score of 6 indicates symptoms of maximum severity. A maximum total score is 60 points. | 6 weeks | |
Primary | MADRS Score - Overall Change From Baseline | The primary objective of the study was to assess the effect of AXS-05 versus bupropion as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS) for change in severity of depressive symptoms. The MADRS is a 10-item scale and items are scored between 0-6 points. For each item, a score of 0 indicates the absence of symptoms, and a score of 6 indicates symptoms of maximum severity. A maximum total score is 60 points. | Assessed at week 1, 2, 3, 4, 5 and 6 (averaged over the entire 6-week treatment period) |
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