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

Axsome Therapeutics

Status and phase: Completed; Phase 3

Conditions: Major Depressive Disorder; Treatment Resistant Depression; Depression

Treatments: Drug: AXS-05 (dextromethorphan and bupropion) oral tablets

Study type: Interventional

Funder types: Industry

Identifiers

NCT04039022

AXS-05-303

Details and patient eligibility

About

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

Full description

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.

Enrollment: 876 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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876 participants in 1 patient group

AXS-05

Experimental group

Treatment:

Drug: AXS-05 (dextromethorphan and bupropion) oral tablets