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Assessing Symptomatic Clinical Episodes in Depression (ASCEND)

Axsome Therapeutics logo

Axsome Therapeutics

Status and phase

Completed
Phase 2

Conditions

Major Depressive Disorder

Treatments

Drug: Bupropion
Drug: AXS-05

Study type

Interventional

Funder types

Industry

Identifiers

NCT03595579
AXS-05-MDD-201

Details and patient eligibility

About

Randomized, Double-Blind, Active-Controlled Study of AXS-05 for MDD.

Full description

This study will evaluate the safety and efficacy of AXS-05 in a randomized, double-blind, active-controlled study in patients diagnosed with major depressive disorder (MDD) experiencing an acute episode.

Enrollment

97 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Currently meets DSM-5 criteria for MDD
  • 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
  • History of treatment resistance in current depressive episode
  • History of electroconvulsive therapy, vagus nerve stimulation, transcranial magnetic stimulation or any experimental central nervous system treatment during the current episode or in the past 6 months
  • Pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study
  • Additional criteria may apply

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

97 participants in 2 patient groups

AXS-05
Experimental group
Treatment:
Drug: AXS-05
Bupropion
Active Comparator group
Treatment:
Drug: Bupropion

Trial documents
2

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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