A Trial of AXS-05 in Patients With Major Depressive Disorder (GEMINI)

Axsome Therapeutics

Status and phase: Completed; Phase 3

Conditions: Major Depressive Disorder; Depression

Treatments: Drug: AXS-05; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04019704

AXS-05-MDD-301

Details and patient eligibility

About

A Phase 3, randomized, double-blind, placebo-controlled, multicenter trial of AXS-05 in patients with major depressive disorder (MDD).

Full description

This study will evaluate AXS-05 in a randomized, double-blind, placebo-controlled study in patients with MDD. Eligible patients will be randomized in a 1:1 ratio to treatment with AXS-05 or placebo for 6 weeks.

Enrollment: 327 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Age 18 - 65
• Currently meets DSM-5 criteria for MDD
• Body Mass Index between 18 and 40 kg/m^2, inclusive

Key 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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327 participants in 2 patient groups, including a placebo group

AXS-05

Experimental group

Description:

AXS-05 (bupropion and dextromethorphan) oral tablets

Treatment:

Drug: AXS-05

Placebo

Placebo Comparator group

Description:

Placebo oral tablets to match AXS-05

Treatment:

Drug: Placebo