Assessing Symptomatic Clinical Episodes in Depression

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

97 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-30

Study Completion Date

2019-01-07

Brief Summary

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

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Detailed Description

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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.

Conditions

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Major Depressive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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AXS-05

Group Type EXPERIMENTAL

AXS-05

Intervention Type DRUG

AXS-05 taken twice daily for 6 weeks.

Bupropion

Group Type ACTIVE_COMPARATOR

Bupropion

Intervention Type DRUG

Bupropion taken twice daily for 6 weeks.

Interventions

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AXS-05

AXS-05 taken twice daily for 6 weeks.

Intervention Type DRUG

Bupropion

Bupropion taken twice daily for 6 weeks.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No