Assessing Symptomatic Clinical Episodes in Depression

Major Depressive Disorder Clinical Trial

— ASCEND  

Official title:

A Randomized, Double-Blind, Active-Controlled Trial of AXS-05 Administered Orally to Subjects With Major Depressive Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03595579
• Other study ID #: AXS-05-MDD-201
• Status: Completed
• Phase: Phase 2
• Start date: May 30, 2018
• Est. completion date: January 7, 2019

Study information

• Verified date: September 2021
• Source: Axsome Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Randomized, Double-Blind, Active-Controlled Study of AXS-05 for MDD.

Description:

This study will evaluate the safety and efficacy of AXS-05 in a randomized, double-blind, active-controlled study in patients diagnosed with major depressive disorder (MDD) experiencing an acute episode.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• AXS-05
AXS-05 taken twice daily for 6 weeks.
• Bupropion
Bupropion taken twice daily for 6 weeks.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Axsome Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

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)

External Links

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