Assessing Symptomatic Clinical Episodes in Depression

Phase 2

Completed

• Conditions: Major Depressive Disorder
• Interventions: Drug: AXS-05; Drug: Bupropion

• Registration Number: NCT03595579
• Lead Sponsor: Axsome Therapeutics, Inc.

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2018-05-30
• Study First Submitted: 2018-06-20
• Study First Submitted QC: 2018-07-12
• Study First Posted: 2018-07-23
• Primary Completion: 2019-01-07
• Study Completion: 2019-01-07
• Results First Submitted: 2021-07-30
• Status Verified: 2021-09
• Results First Submitted QC: 2021-09-22
• Last Update Submitted: 2021-09-22
• Results First Posted: 2021-09-24
• Last Update Posted: 2021-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 97

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AXS-05	AXS-05	-
Bupropion	Bupropion	-

Primary Outcome Measures

Name	Time	Method
MADRS Score - Overall Change From Baseline	Assessed at week 1, 2, 3, 4, 5 and 6 (averaged over the entire 6-week treatment period)	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.

Trial Locations

Locations (1)

Clinical Research Site; 🇺🇸 Bellevue, Washington, United States