Assessing Symptomatic Clinical Episodes in Depression (ASCEND)

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

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97 participants in 2 patient groups

AXS-05

Experimental group

Treatment:

Drug: AXS-05

Bupropion

Active Comparator group

Treatment:

Drug: Bupropion