A Study to Assess the Efficacy and Safety of AXS-05 in Subjects With Treatment Resistant Major Depressive Disorder (STRIDE-1)

March 22, 2021 updated by: Axsome Therapeutics, Inc.

STRIDE-1: A Randomized, Double-blind, Active-controlled Trial to Assess the Efficacy and Safety of AXS-05 Administered Orally to Subjects With Treatment Resistant Major Depressive Disorder

To evaluate the efficacy and safety of AXS-05 relative to bupropion in subjects with treatment resistant major depressive disorder (MDD).

This is a randomized, double-blind, active-controlled, 12-week, two-period study consisting of an open-label, bupropion lead-in period, and a double-blind treatment period. The trial is being conducted in subjects with treatment resistant MDD.

Subjects will be considered to have treatment resistant MDD if they have had a historical inadequate response to 1 or 2 antidepressant treatments and a prospective inadequate response to treatment with bupropion during the open-label, lead-in period.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

312

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States
    • Arkansas
      • Little Rock, Arkansas, United States
    • California
      • Anaheim, California, United States
      • Beverly Hills, California, United States
      • Garden Grove, California, United States
      • Oakland, California, United States
      • Oceanside, California, United States
      • Panorama City, California, United States
      • Redlands, California, United States
      • Riverside, California, United States
      • San Diego, California, United States
      • San Francisco, California, United States
      • Sherman Oaks, California, United States
      • Temecula, California, United States
      • Upland, California, United States
    • Colorado
      • Colorado Springs, Colorado, United States
    • Connecticut
      • Cromwell, Connecticut, United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20016
    • Florida
      • Coral Springs, Florida, United States
      • Fort Lauderdale, Florida, United States
      • Fort Myers, Florida, United States
      • Gainesville, Florida, United States
      • Jacksonville, Florida, United States, 32256
      • Lakeland, Florida, United States
      • North Miami, Florida, United States
      • Orlando, Florida, United States
      • Pensacola, Florida, United States
      • Saint Petersburg, Florida, United States
    • Georgia
      • Atlanta, Georgia, United States, 30328
    • Idaho
      • Boise, Idaho, United States
    • Illinois
      • Skokie, Illinois, United States
    • Louisiana
      • Shreveport, Louisiana, United States
    • Maryland
      • Baltimore, Maryland, United States
    • Missouri
      • Saint Charles, Missouri, United States
      • Saint Louis, Missouri, United States
    • Nebraska
      • Lincoln, Nebraska, United States
    • Nevada
      • Las Vegas, Nevada, United States
    • New Hampshire
      • Nashua, New Hampshire, United States
    • New Jersey
      • Berlin, New Jersey, United States
      • Cherry Hill, New Jersey, United States
      • Marlton, New Jersey, United States
      • Princeton, New Jersey, United States
      • Toms River, New Jersey, United States
    • New Mexico
      • Albuquerque, New Mexico, United States
    • New York
      • Brooklyn, New York, United States
      • Jamaica, New York, United States, 11432
      • New York, New York, United States
      • Rochester, New York, United States
      • Staten Island, New York, United States
    • North Carolina
      • Charlotte, North Carolina, United States
    • Ohio
      • Canton, Ohio, United States
      • Dayton, Ohio, United States
      • Middleburg Heights, Ohio, United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
    • Oregon
      • Portland, Oregon, United States
      • Salem, Oregon, United States
    • Pennsylvania
      • Allentown, Pennsylvania, United States
      • Media, Pennsylvania, United States
      • Philadelphia, Pennsylvania, United States
    • Rhode Island
      • Lincoln, Rhode Island, United States
    • South Carolina
      • Charleston, South Carolina, United States
    • Tennessee
      • Memphis, Tennessee, United States, 38119
    • Texas
      • Austin, Texas, United States
      • Dallas, Texas, United States
      • Houston, Texas, United States
      • San Antonio, Texas, United States
      • Wichita Falls, Texas, United States
    • Utah
      • Orem, Utah, United States
    • Virginia
      • Charlottesville, Virginia, United States
      • Herndon, Virginia, United States
    • Washington
      • Bellevue, Washington, United States
      • Seattle, Washington, United States
      • Spokane, Washington, United States
    • Wisconsin
      • Waukesha, Wisconsin, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Key Inclusion Criteria:

  • Currently meets DSM-V criteria for MDD
  • History of inadequate response to 1 or 2 adequate antidepressant treatments
  • Body mass index (BMI) between 18 and 40 kg/m2, inclusive
  • Agree to use adequate method of contraception for the duration of the study
  • Additional criteria may apply

Key Exclusion Criteria:

  • Suicide risk
  • Treatment with any investigational drug within 6 months
  • History of electroconvulsive therapy (ECT), 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AXS-05
Drug: AXS-05
AXS-05 taken daily for 6 weeks.
Active Comparator: Bupropion
Drug: Bupropion
Buproprion taken daily for 6 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Montgomery-Åsberg Depression Rating Scale (MADRS) total score
Time Frame: MADRS change from Baseline to End of Study (6 weeks)
The MADRS is used to assess depressive symptomatology during the previous week. Subjects are rated on 10 items to assess feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating and lack of interest. Each item is scored on a 7-point scale. A score of 0 indicates the absence of symptoms, and a score of 6 indicates symptoms of maximum severity.
MADRS change from Baseline to End of Study (6 weeks)

Secondary Outcome Measures

Outcome Measure
Time Frame
Clinical Global Impressions-Severity (CGI-S)
Time Frame: Baseline to End of Study (6 weeks)
Baseline to End of Study (6 weeks)
Hamilton Depression Rating Scale - 17 items (HAMD-17)
Time Frame: Baseline to End of Study (6 weeks)
Baseline to End of Study (6 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Axsome Therapeutics, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Actual)

March 20, 2020

Study Completion (Actual)

March 20, 2020

Study Registration Dates

First Submitted

April 5, 2016

First Submitted That Met QC Criteria

April 14, 2016

First Posted (Estimate)

April 18, 2016

Study Record Updates

Last Update Posted (Actual)

March 24, 2021

Last Update Submitted That Met QC Criteria

March 22, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AXS-05-301

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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