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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)

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ClinicalTrials.gov Identifier: NCT02741791
Recruitment Status : Recruiting
First Posted : April 18, 2016
Last Update Posted : June 27, 2018
Sponsor:
Information provided by (Responsible Party):
Axsome Therapeutics, Inc.

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.


Condition or disease Intervention/treatment Phase
Treatment Resistant Major Depressive Disorder Drug: AXS-05 Drug: Bupropion Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : March 2016
Estimated Primary Completion Date : December 2018

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Clinical Global Impressions-Severity (CGI-S) [ Time Frame: Baseline to End of Study (6 weeks) ]
  2. Hamilton Depression Rating Scale - 17 items (HAMD-17) [ Time Frame: Baseline to End of Study (6 weeks) ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02741791


Contacts
Contact: Kellie A. Kennon, BSN Study Director stride-1@axsome.com

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

Additional Information:
Responsible Party: Axsome Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02741791     History of Changes
Other Study ID Numbers: AXS-05-301
First Posted: April 18, 2016    Key Record Dates
Last Update Posted: June 27, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: via publication

Keywords provided by Axsome Therapeutics, Inc.:
AXS-05
Major Depressive Disorder
Treatment Resistant Depression
TRD
MDD
Axsome
NMDA receptor
Refractory depression
Resistant depression
Depression

Additional relevant MeSH terms:
Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Bupropion
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors