Open-Label Safety Study of AXS-05 in Subjects With Depression

Axsome Therapeutics, Inc.876 enrolled

Overview

An open-label, long-term, safety study of AXS-05 in patients with major depressive disorder (MDD), including treatment resistant depression.

A multi-center, open-label, long-term study to evaluate the safety and efficacy of AXS-05 in patients with major depressive disorder, including treatment resistant depression, treated for up to one year.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

876

Conditions

Major Depressive Disorder Treatment Resistant Depression Depression

Interventions

AXS-05 (dextromethorphan and bupropion) oral tabletsDRUG

Oral tablets, taken twice daily for up to 12 months.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosis of major depressive disorder, including treatment resistant depression * 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 * Pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study * Additional criteria may apply

Locations (51)

Outcomes

Primary Outcomes

Incidence of Treatment-emergent AEs (TEAEs) Following Dosing With AXS-05

Types and rates of adverse events

Time frame: Up to 12 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Clinical Research Site

Phoenix, Arizona, United States

Clinical Research Site

Little Rock, Arkansas, United States

Clinical Research Site

Bellflower, California, United States

Clinical Research Site

Beverly Hills, California, United States

Clinical Research Site

Culver City, California, United States

Clinical Research Site

Garden Grove, California, United States

Clinical Research Site

Oakland, California, United States

Clinical Research Site

Oceanside, California, United States

Clinical Research Site

Panorama City, California, United States

Clinical Research Site

Redlands, California, United States

...and 41 more locations