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

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

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Key information

Conditions

Major Depressive Disorder Behavior Behavioral Symptoms Depression Depressive Disorder Depressive Disorder, Major Depressive Disorder, Treatment-Resistant Mental Disorders Mood Disorders Treatment Resistant Depression

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Clinical Research Site, Phoenix, Arizona, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AXS-05 (dextromethorphan and bupropion) oral tablets

Drug

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

Primary outcomes

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

Time frame: Up to 12 months

Types and rates of adverse events

Sponsors and collaborators

Lead sponsor

Axsome Therapeutics, Inc.

Industry

Registry information

Official study title

An Open-Label Study to Assess the Long-term Safety and Efficacy of AXS-05 in Subjects With Major Depressive Disorder

Important dates

Study start: 2019
Primary completion: 2020
Study completion: 2020
First posted: Jul 31, 2019
Registry last updated: Oct 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed