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

Axsome Therapeutics logo

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)

876 participants in 1 patient group

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

Trial documents
1

Trial contacts and locations

51

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Data sourced from clinicaltrials.gov

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