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

Primary Purpose

Treatment Resistant Major Depressive Disorder

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
AXS-05
Bupropion
Sponsored by
Axsome Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Treatment Resistant Major Depressive Disorder focused on measuring AXS-05, Major Depressive Disorder, Treatment Resistant Depression, TRD, MDD, Axsome, NMDA receptor, Refractory depression, Resistant depression, Depression

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

AXS-05

Bupropion

Arm Description

Outcomes

Primary Outcome Measures

Montgomery-Åsberg Depression Rating Scale (MADRS) total score
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.

Secondary Outcome Measures

Clinical Global Impressions-Severity (CGI-S)
Hamilton Depression Rating Scale - 17 items (HAMD-17)

Full Information

First Posted
April 5, 2016
Last Updated
March 22, 2021
Sponsor
Axsome Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02741791
Brief Title
A Study to Assess the Efficacy and Safety of AXS-05 in Subjects With Treatment Resistant Major Depressive Disorder
Acronym
STRIDE-1
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
March 20, 2020 (Actual)
Study Completion Date
March 20, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Axsome Therapeutics, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Treatment Resistant Major Depressive Disorder
Keywords
AXS-05, Major Depressive Disorder, Treatment Resistant Depression, TRD, MDD, Axsome, NMDA receptor, Refractory depression, Resistant depression, Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
312 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AXS-05
Arm Type
Experimental
Arm Title
Bupropion
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
AXS-05
Intervention Description
AXS-05 taken daily for 6 weeks.
Intervention Type
Drug
Intervention Name(s)
Bupropion
Intervention Description
Buproprion taken daily for 6 weeks.
Primary Outcome Measure Information:
Title
Montgomery-Åsberg Depression Rating Scale (MADRS) total score
Description
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.
Time Frame
MADRS change from Baseline to End of Study (6 weeks)
Secondary Outcome Measure Information:
Title
Clinical Global Impressions-Severity (CGI-S)
Time Frame
Baseline to End of Study (6 weeks)
Title
Hamilton Depression Rating Scale - 17 items (HAMD-17)
Time Frame
Baseline to End of Study (6 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
City
Phoenix
State/Province
Arizona
Country
United States
City
Little Rock
State/Province
Arkansas
Country
United States
City
Anaheim
State/Province
California
Country
United States
City
Beverly Hills
State/Province
California
Country
United States
City
Garden Grove
State/Province
California
Country
United States
City
Oakland
State/Province
California
Country
United States
City
Oceanside
State/Province
California
Country
United States
City
Panorama City
State/Province
California
Country
United States
City
Redlands
State/Province
California
Country
United States
City
Riverside
State/Province
California
Country
United States
City
San Diego
State/Province
California
Country
United States
City
San Francisco
State/Province
California
Country
United States
City
Sherman Oaks
State/Province
California
Country
United States
City
Temecula
State/Province
California
Country
United States
City
Upland
State/Province
California
Country
United States
City
Colorado Springs
State/Province
Colorado
Country
United States
City
Cromwell
State/Province
Connecticut
Country
United States
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20016
Country
United States
City
Coral Springs
State/Province
Florida
Country
United States
City
Fort Lauderdale
State/Province
Florida
Country
United States
City
Fort Myers
State/Province
Florida
Country
United States
City
Gainesville
State/Province
Florida
Country
United States
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
City
Lakeland
State/Province
Florida
Country
United States
City
North Miami
State/Province
Florida
Country
United States
City
Orlando
State/Province
Florida
Country
United States
City
Pensacola
State/Province
Florida
Country
United States
City
Saint Petersburg
State/Province
Florida
Country
United States
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
City
Boise
State/Province
Idaho
Country
United States
City
Skokie
State/Province
Illinois
Country
United States
City
Shreveport
State/Province
Louisiana
Country
United States
City
Baltimore
State/Province
Maryland
Country
United States
City
Saint Charles
State/Province
Missouri
Country
United States
City
Saint Louis
State/Province
Missouri
Country
United States
City
Lincoln
State/Province
Nebraska
Country
United States
City
Las Vegas
State/Province
Nevada
Country
United States
City
Nashua
State/Province
New Hampshire
Country
United States
City
Berlin
State/Province
New Jersey
Country
United States
City
Cherry Hill
State/Province
New Jersey
Country
United States
City
Marlton
State/Province
New Jersey
Country
United States
City
Princeton
State/Province
New Jersey
Country
United States
City
Toms River
State/Province
New Jersey
Country
United States
City
Albuquerque
State/Province
New Mexico
Country
United States
City
Brooklyn
State/Province
New York
Country
United States
City
Jamaica
State/Province
New York
ZIP/Postal Code
11432
Country
United States
City
New York
State/Province
New York
Country
United States
City
Rochester
State/Province
New York
Country
United States
City
Staten Island
State/Province
New York
Country
United States
City
Charlotte
State/Province
North Carolina
Country
United States
City
Canton
State/Province
Ohio
Country
United States
City
Dayton
State/Province
Ohio
Country
United States
City
Middleburg Heights
State/Province
Ohio
Country
United States
City
Oklahoma City
State/Province
Oklahoma
Country
United States
City
Portland
State/Province
Oregon
Country
United States
City
Salem
State/Province
Oregon
Country
United States
City
Allentown
State/Province
Pennsylvania
Country
United States
City
Media
State/Province
Pennsylvania
Country
United States
City
Philadelphia
State/Province
Pennsylvania
Country
United States
City
Lincoln
State/Province
Rhode Island
Country
United States
City
Charleston
State/Province
South Carolina
Country
United States
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
City
Austin
State/Province
Texas
Country
United States
City
Dallas
State/Province
Texas
Country
United States
City
Houston
State/Province
Texas
Country
United States
City
San Antonio
State/Province
Texas
Country
United States
City
Wichita Falls
State/Province
Texas
Country
United States
City
Orem
State/Province
Utah
Country
United States
City
Charlottesville
State/Province
Virginia
Country
United States
City
Herndon
State/Province
Virginia
Country
United States
City
Bellevue
State/Province
Washington
Country
United States
City
Seattle
State/Province
Washington
Country
United States
City
Spokane
State/Province
Washington
Country
United States
City
Waukesha
State/Province
Wisconsin
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://www.TRDstudy.com
Description
www.TRDstudy.com

Learn more about this trial

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

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