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

NCT ID: NCT04039022

Last Updated: 2022-10-12

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

876 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-08

Study Completion Date

2020-10-23

Brief Summary

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An open-label, long-term, safety study of AXS-05 in patients with major depressive disorder (MDD), including treatment resistant depression.

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Detailed Description

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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.

Conditions

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Major Depressive Disorder Treatment Resistant Depression Depression

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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AXS-05

Group Type EXPERIMENTAL

AXS-05 (dextromethorphan and bupropion) oral tablets

Intervention Type DRUG

Oral tablets, taken twice daily for up to 12 months.

Interventions

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AXS-05 (dextromethorphan and bupropion) oral tablets

Oral tablets, taken twice daily for up to 12 months.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Axsome Therapeutics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Clinical Research Site

Phoenix, Arizona, United States

Site Status

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Little Rock, Arkansas, United States

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Bellflower, California, United States

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Beverly Hills, California, United States

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Culver City, California, United States

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Garden Grove, California, United States

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Oakland, California, United States

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Oceanside, California, United States

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Panorama City, California, United States

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Redlands, California, United States

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San Diego, California, United States

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Sherman Oaks, California, United States

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Upland, California, United States

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Cromwell, Connecticut, United States

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Coral Springs, Florida, United States

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Hialeah, Florida, United States

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Hollywood, Florida, United States

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Jacksonville, Florida, United States

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Lauderhill, Florida, United States

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Miami, Florida, United States

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North Miami, Florida, United States

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Orlando, Florida, United States

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Atlanta, Georgia, United States

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Atlanta, Georgia, United States

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Boise, Idaho, United States

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Chicago, Illinois, United States

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Boston, Massachusetts, United States

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Las Vegas, Nevada, United States

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Berlin, New Jersey, United States

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Cherry Hill, New Jersey, United States

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Toms River, New Jersey, United States

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Jamaica, New York, United States

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Rochester, New York, United States

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Staten Island, New York, United States

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Hickory, North Carolina, United States

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Raleigh, North Carolina, United States

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Cincinnati, Ohio, United States

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Cincinnati, Ohio, United States

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Middleburg Heights, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Media, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Memphis, Tennessee, United States

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Austin, Texas, United States

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Dallas, Texas, United States

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Fort Worth, Texas, United States

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Houston, Texas, United States

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San Antonio, Texas, United States

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Wichita Falls, Texas, United States

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Bellevue, Washington, United States

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Clinical Research Site

Everett, Washington, United States

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Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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AXS-05-303

Identifier Type: -

Identifier Source: org_study_id

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