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



Status:Recruiting
Conditions:Depression, Depression, Major Depression Disorder (MDD)
Therapuetic Areas:Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - 65
Updated:11/16/2018
Start Date:March 2016
End Date:March 2019
Contact:Cheryl Askew
Email:stride-1@axsome.com
Phone:Study Director

Use our guide to learn which trials are right for you!

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.


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
We found this trial at
75
sites
?
mi
from
Pensacola, FL
Click here to add this to my saved trials
?
mi
from
Albuquerque, NM
Click here to add this to my saved trials
?
mi
from
Allentown, PA
Click here to add this to my saved trials
?
mi
from
Anaheim, CA
Click here to add this to my saved trials
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
?
mi
from
Austin, TX
Click here to add this to my saved trials
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
?
mi
from
Bellevue, WA
Click here to add this to my saved trials
?
mi
from
Berlin, NJ
Click here to add this to my saved trials
Beverly Hills, California 90211
?
mi
from
Beverly Hills, CA
Click here to add this to my saved trials
?
mi
from
Boise, ID
Click here to add this to my saved trials
?
mi
from
Brooklyn, NY
Click here to add this to my saved trials
?
mi
from
Canton, OH
Click here to add this to my saved trials
Charleston, South Carolina 29412
?
mi
from
Charleston, SC
Click here to add this to my saved trials
Charlotte, North Carolina 28207
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
?
mi
from
Charlottesville, VA
Click here to add this to my saved trials
?
mi
from
Cherry Hill, NJ
Click here to add this to my saved trials
Colorado Springs, Colorado 80910
?
mi
from
Colorado Springs, CO
Click here to add this to my saved trials
?
mi
from
Coral Springs, FL
Click here to add this to my saved trials
?
mi
from
Cromwell, CT
Click here to add this to my saved trials
?
mi
from
Dallas, TX
Click here to add this to my saved trials
?
mi
from
Dayton, OH
Click here to add this to my saved trials
?
mi
from
Fort Lauderdale, FL
Click here to add this to my saved trials
?
mi
from
Fort Myers, FL
Click here to add this to my saved trials
?
mi
from
Gainesville, FL
Click here to add this to my saved trials
?
mi
from
Garden Grove, CA
Click here to add this to my saved trials
?
mi
from
Herndon, VA
Click here to add this to my saved trials
?
mi
from
Houston, TX
Click here to add this to my saved trials
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
?
mi
from
Jamaica, NY
Click here to add this to my saved trials
?
mi
from
Lakeland, FL
Click here to add this to my saved trials
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
?
mi
from
Lincoln, NE
Click here to add this to my saved trials
?
mi
from
Lincoln, RI
Click here to add this to my saved trials
?
mi
from
Little Rock, AR
Click here to add this to my saved trials
?
mi
from
Marlton, NJ
Click here to add this to my saved trials
?
mi
from
Media, PA
Click here to add this to my saved trials
?
mi
from
Memphis, TN
Click here to add this to my saved trials
?
mi
from
Middleburg Heights, OH
Click here to add this to my saved trials
?
mi
from
Nashua, NH
Click here to add this to my saved trials
?
mi
from
New York, NY
Click here to add this to my saved trials
?
mi
from
North Miami, FL
Click here to add this to my saved trials
?
mi
from
Oakland, CA
Click here to add this to my saved trials
?
mi
from
Oceanside, CA
Click here to add this to my saved trials
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
?
mi
from
Orem, UT
Click here to add this to my saved trials
?
mi
from
Orlando, FL
Click here to add this to my saved trials
?
mi
from
Panorama City, CA
Click here to add this to my saved trials
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
?
mi
from
Portland, OR
Click here to add this to my saved trials
?
mi
from
Princeton, NJ
Click here to add this to my saved trials
?
mi
from
Redlands, CA
Click here to add this to my saved trials
?
mi
from
Riverside, CA
Click here to add this to my saved trials
?
mi
from
Rochester, NY
Click here to add this to my saved trials
?
mi
from
Saint Charles, MO
Click here to add this to my saved trials
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
Saint Petersburg, Florida 33713
?
mi
from
Saint Petersburg, FL
Click here to add this to my saved trials
?
mi
from
Salem, OR
Click here to add this to my saved trials
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
?
mi
from
San Diego, CA
Click here to add this to my saved trials
?
mi
from
San Francisco, CA
Click here to add this to my saved trials
?
mi
from
Seattle, WA
Click here to add this to my saved trials
?
mi
from
Sherman Oaks, CA
Click here to add this to my saved trials
?
mi
from
Shreveport, LA
Click here to add this to my saved trials
?
mi
from
Skokie, IL
Click here to add this to my saved trials
?
mi
from
Spokane, WA
Click here to add this to my saved trials
?
mi
from
Staten Island, NY
Click here to add this to my saved trials
?
mi
from
Temecula, CA
Click here to add this to my saved trials
?
mi
from
Toms River, NJ
Click here to add this to my saved trials
?
mi
from
Upland, CA
Click here to add this to my saved trials
?
mi
from
Washington,
Click here to add this to my saved trials
?
mi
from
Waukesha, WI
Click here to add this to my saved trials
?
mi
from
Weymouth, MA
Click here to add this to my saved trials
?
mi
from
Wichita Falls, TX
Click here to add this to my saved trials