A Study of ALKS 5461 for the Treatment of Major Depressive Disorder (MDD) - the FORWARD-4 Study



Status:Completed
Conditions:Depression, Depression, Major Depression Disorder (MDD)
Therapuetic Areas:Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - 70
Updated:3/29/2019
Start Date:May 2014
End Date:December 2015

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

A Phase 3 Efficacy and Safety Study of ALKS 5461 for the Adjunctive Treatment of Major Depressive Disorder (the FORWARD-4 Study)

This study will evaluate the efficacy and safety of ALKS 5461.


Inclusion Criteria:

- Have a Body Mass Index (BMI) of 18.0 to 40.0 kg/m2, inclusive

- Agree to use an acceptable method of contraception for the duration of the study

- Have a Major Depressive Disorder (MDD) primary diagnosis

- Have no more than 2 inadequate responses to antidepressant therapy (ADT) in the
current Major Depressive Episode (MDE)

- Additional criteria may apply

Exclusion Criteria:

- Have a current primary Axis-I disorder other than MDD

- Have used opioid agonists (eg, codeine, oxycodone, tramadol, morphine) or opioid
antagonists (eg, naloxone, naltrexone) within 14 days

- Have received electroconvulsive therapy treatment within the last 2 years or received
more than one course of electroconvulsive treatment during lifetime

- Have attempted suicide within the past 2 years

- Have a positive test for drugs of abuse

- Are pregnant, planning to become pregnant, or breastfeeding

- Have a history of intolerance, allergy, or hypersensitivity to buprenorphine or opioid
antagonists (eg, naltrexone, naloxone)

- Have had a significant blood loss or blood donation within 60 days

- Additional criteria may apply
We found this trial at
43
sites
Sherman Oaks, California
25
mi
from 91732
Sherman Oaks, CA
Click here to add this to my saved trials
Allentown, Pennsylvania 18104
2355
mi
from 91732
Allentown, PA
Click here to add this to my saved trials
Alpharetta, Georgia 30005
1920
mi
from 91732
Alpharetta, GA
Click here to add this to my saved trials
Austin, Texas 78731
1212
mi
from 91732
Austin, TX
Click here to add this to my saved trials
Baltimore, Maryland 21285
2301
mi
from 91732
Baltimore, MD
Click here to add this to my saved trials
Baltimore, Maryland 21285
2301
mi
from 91732
Baltimore, MD
Click here to add this to my saved trials
Berlin, New Jersey
2388
mi
from 91732
Berlin, NJ
Click here to add this to my saved trials
Birmingham, Alabama
1785
mi
from 91732
Birmingham, AL
Click here to add this to my saved trials
Brisbane, Queensland
7198
mi
from 91732
Brisbane,
Click here to add this to my saved trials
Brooklyn, New York
2436
mi
from 91732
Brooklyn, NY
Click here to add this to my saved trials
Canton, Ohio 44718
2047
mi
from 91732
Canton, OH
Click here to add this to my saved trials
Carson, California
22
mi
from 91732
Carson, CA
Click here to add this to my saved trials
Chicago, Illinois 60611
1729
mi
from 91732
Chicago, IL
Click here to add this to my saved trials
Coral Springs, Florida
2304
mi
from 91732
Coral Springs, FL
Click here to add this to my saved trials
Dayton, Ohio 45417
1892
mi
from 91732
Dayton, OH
Click here to add this to my saved trials
Decatur, Georgia 30030
1924
mi
from 91732
Decatur, GA
Click here to add this to my saved trials
Gainesville, Florida 32607
2100
mi
from 91732
Gainesville, FL
Click here to add this to my saved trials
Hartford, Connecticut 06106
2496
mi
from 91732
Hartford, CT
Click here to add this to my saved trials
Houston, Texas 77007
1354
mi
from 91732
Houston, TX
Click here to add this to my saved trials
1703
mi
from 91732
Joliet, IL
Click here to add this to my saved trials
Lauderhill, Florida 33161
2319
mi
from 91732
Lauderhill, FL
Click here to add this to my saved trials
Lincoln, Rhode Island
2560
mi
from 91732
Lincoln, RI
Click here to add this to my saved trials
Media, Pennsylvania
2363
mi
from 91732
Media, PA
Click here to add this to my saved trials
Middleton, Wisconsin
1651
mi
from 91732
Middleton, WI
Click here to add this to my saved trials
Mount Kisco, New York
2445
mi
from 91732
Mount Kisco, NY
Click here to add this to my saved trials
National City, California 91950
110
mi
from 91732
National City, CA
Click here to add this to my saved trials
New York, New York 10021
2432
mi
from 91732
New York, NY
Click here to add this to my saved trials
Newburgh, Indiana 47630
1723
mi
from 91732
Newburgh, IN
Click here to add this to my saved trials
Norwich, Connecticut
2529
mi
from 91732
Norwich, CT
Click here to add this to my saved trials
Oklahoma City, Oklahoma
1164
mi
from 91732
Oklahoma City, OK
Click here to add this to my saved trials
Oklahoma City, Oklahoma
1164
mi
from 91732
Oklahoma City, OK
Click here to add this to my saved trials
Orange, California 92868
21
mi
from 91732
Orange, CA
Click here to add this to my saved trials
Orlando, Florida 32810
2179
mi
from 91732
Orlando, FL
Click here to add this to my saved trials
Owensboro, Kentucky
1739
mi
from 91732
Owensboro, KY
Click here to add this to my saved trials
Philadelphia, Pennsylvania 19131
2375
mi
from 91732
Philadelphia, PA
Click here to add this to my saved trials
San Antonio, Texas
1188
mi
from 91732
San Antonio, TX
Click here to add this to my saved trials
1725
mi
from 91732
Skokie, IL
Click here to add this to my saved trials
Staten Island, New York 10305
2429
mi
from 91732
Staten Island, NY
Click here to add this to my saved trials
Torrance, California 90502
22
mi
from 91732
Torrance, CA
Click here to add this to my saved trials
Tucson, Arizona 85712
430
mi
from 91732
Tucson, AZ
Click here to add this to my saved trials
Upland, California 91786
20
mi
from 91732
Upland, CA
Click here to add this to my saved trials
Valparaiso, Indiana
1755
mi
from 91732
Valparaiso, IN
Click here to add this to my saved trials
Woodstock, Vermont
2501
mi
from 91732
Woodstock, VT
Click here to add this to my saved trials