Assessing Symptomatic Clinical Episodes in Depression

Axsome Therapeutics, Inc.97 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Major Depressive Disorder

Interventions

AXS-05DRUG

AXS-05 taken twice daily for 6 weeks.

BupropionDRUG

Bupropion taken twice daily for 6 weeks.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (4)

Clinical Research Site

Beverly Hills, California, United States

Clinical Research Site

Jacksonville, Florida, United States

Clinical Research Site

Orlando, Florida, United States

Clinical Research Site

Bellevue, Washington, United States

Outcomes

Primary Outcomes

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.

Time frame: Assessed at week 1, 2, 3, 4, 5 and 6 (averaged over the entire 6-week treatment period)

Data from ClinicalTrials.gov

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