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

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04039022
Enrollment
876
Registered
2019-07-31
Start date
2019-07-08
Completion date
2020-10-23
Last updated
2022-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression, Major Depressive Disorder, Treatment Resistant Depression

Keywords

Depression, AXS-05, Dextromethorphan, Bupropion, Dopamine Reuptake Inhibitor, NMDA Receptor Antagonist, Nicotinic Acetylcholine Receptor Antagonist, Serotonin Reuptake Inhibitor, Axsome Therapeutics, Norepinephrine Reuptake Inhibitor, Sigma-1 Receptor Agonist, Glutamate Modulator, Antidepressant

Brief summary

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

Detailed 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.

Interventions

DRUGAXS-05 (dextromethorphan and bupropion) oral tablets

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

Sponsors

Axsome Therapeutics, Inc.
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Incidence of Treatment-emergent AEs (TEAEs) Following Dosing With AXS-05Up to 12 monthsTypes and rates of adverse events

Countries

United States

Participant flow

Participants by arm

ArmCount
AXS-05
AXS-05: Oral tablets, taken twice daily for up to 12 months.
876
Total876

Baseline characteristics

CharacteristicAXS-05
Age, Continuous42.5 years
STANDARD_DEVIATION 13.5
Race (NIH/OMB)
American Indian or Alaska Native
3 Participants
Race (NIH/OMB)
Asian
29 Participants
Race (NIH/OMB)
Black or African American
301 Participants
Race (NIH/OMB)
More than one race
10 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
4 Participants
Race (NIH/OMB)
Unknown or Not Reported
20 Participants
Race (NIH/OMB)
White
509 Participants
Sex: Female, Male
Female
560 Participants
Sex: Female, Male
Male
316 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
2 / 876
other
Total, other adverse events
609 / 876
serious
Total, serious adverse events
21 / 876

Outcome results

Primary

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

Types and rates of adverse events

Time frame: Up to 12 months

Population: Primary Safety Population (subjects who continued beyond Week 6 of the trial)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
AXS-05Incidence of Treatment-emergent AEs (TEAEs) Following Dosing With AXS-05505 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026