A Long-term Safety Study of Intranasal Esketamine in Treatment-resistant Depression



Status:Recruiting
Conditions:Depression, Depression
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - Any
Updated:3/13/2019
Start Date:June 2016
End Date:October 2022
Contact:Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions:
Email:JNJ.CT@sylogent.com

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

An Open-label Long-term Extension Safety Study of Intranasal Esketamine in Treatment-resistant Depression

The purpose of this study is to assess the safety and tolerability of intranasal esketamine
in participants with treatment-resistant depression (TRD).

This is an open-label (the researchers and participants know the treatment the participant is
receiving) long-term extension study. The study will consist of 2 open-label Phases: 4-week
Induction phase (if applicable) and Open-Label Optimization/Maintenance phase (variable).
Participants will enter the study Induction Phase from ESKETINTRD3001 (NCT02417064),
ESKETINTRD3002 (NCT02418585), ESKETINTRD3003 (NCT02493868), ESKETINTRD3005 (NCT02422186) and
ESKETINTRD3006 (US sites only). Participants will enter the study Open-Label
Optimization/Maintenance phase from ESKETINTRD3001 (NCT02417064), ESKETINTRD3002
(NCT02418585), ESKETINTRD3003 (NCT02493868) (if appropriate at week 16) or ESKETINTRD3006 (US
sites only). In the Open-Label Induction Phase, participants will self-administer
flexibly-dosed intranasal esketamine. During first 4 weeks in Optimization/Maintenance Phase
responder participants from the induction phase of study 54135419TRD3008, will continue on
the same dose of intranasal esketamine from the induction phase and have a weekly intranasal
treatment session frequency. Participants entering the optimization/maintenance phase from
study ESKETINTRD3005 will also have a weekly intranasal treatment session frequency. However,
as the ESKETINTRD3005 intranasal study medication is blinded at the time of entry into the
current study, the dose of intranasal esketamine will be administered as outlined in
protocol. Participants entering the optimization/maintenance phase from study ESKETINTRD3003
(Direct Entry) or ESKETINTRD3004 who were ongoing in the Optimization, Maintenance, or
Optimization/Maintenance phase, respectively, will have the option to have their current
intranasal dosing frequency adjusted at the time of entry into 54135419TRD3008 study and
should remain on the selected frequency from week 1 to week 4. A one-time dose change will be
permitted at study entry. After 4 weeks, intranasal esketamine treatment sessions will be
individualized to either once weekly or once every other week at the fixed 2-week interval
(based on clinical global impression - severity [CGI-S] performed at that visit), and every 4
weeks for subjects dosed at the 4 week interval. Participants safety will be monitored
throughout the study.

Inclusion Criteria:

- Based on the prior study the participant is entering 54135419TRD3008 from: a) From
ESKETINTRD3001 (NCT02417064) or ESKETINTRD3002 (NCT02418585) study: Participant has
completed the induction phase and the 2-weeks follow up phase visit; or Participants
completed the induction phase and was a responder and study ESKETINTRD3003 is
terminated.; b) From ESKETINTRD3003 (NCT02493868) study: (1) Participant relapsed
during the maintenance phase; or (2) Participant was in the induction phase of the
ESKETINTRD3003 study when the study was terminated and, after completion of the
induction phase, was determined to be a responder; or (3) Participant was in the
optimization or maintenance phases at the time the study was terminated; or (4) or (5)
Participants was in the induction phase and after completion of induction phase was
determined to not meet response criteria (1) Participant completed ESKETINTRD3004
study (optimization/maintenance phase); or (2) Participant was in the induction phase
of the ESKETINTRD3004 study when the study was terminated and, after completion of the
induction phase, was determined to be a responder; or (3) Participant was in the
optimization/maintenance phase at the time the study was terminated; (4) Participant
was in the induction phase and did not meet criteria for response may be eligible for
to be rolled over into 54135419TRD3008. d) From ESKETINTRD3005 (NCT02422186) study:
Participant was in the induction phase of the ESKETINTRD3005 study at the time
enrollment into the ESKETINTRD3004 study was closed and, after completion of the
induction phase, was determined to be a responder or did not meet the criteria for
response. e) From ESKETINTRD3006 study (US Study sites only) (1) Participant completed
the induction phase and was a responder.

- Participant must be medically stable on the basis of physical examination, vital
signs, pulse oximetry, and 12-lead Electrocardiogram (ECG) performed predose on the
day of the first intranasal treatment session. If there are any abnormalities that are
not specified in the inclusion and exclusion criteria, their clinical significance
must be determined by the investigator and recorded in the participant's source
documents and initialed by the investigator

- Participant must be medically stable according to the investigator's judgment and
knowledge of the subject's medical stability in the parent study. This determination
must be documented.

- A woman of childbearing potential must have a negative serum (beta-human chorionic
gonadotropin [b-hCG]) predose on the day of the first intranasal treatment session

- During the study (that is, from the first intranasal treatment session) and for a
minimum of 1 spermatogenesis cycle (defined as approximately 90 days) after receiving
the last dose of intranasal study medication, a man who is sexually active with a
woman of childbearing potential must be practicing a highly effective method of
contraception with his female partner c) must agree not to donate sperm.

Exclusion Criteria:

- The evaluation of the benefit versus risk of continued intranasal esketamine treatment
is not favorable for the participant in the opinion of the investigator

- Since the last study visit in the participant's prior study, participant has suicidal
ideation with intent to act per the investigator's clinical judgment or based on the
Columbia Suicide Severity Rating Scale (C-SSRS) [corresponding to a response of "Yes"
on Item 4 (active suicidal ideation with some intent to act, without specific plan) or
Item 5 (active suicidal ideation with specific plan and intent) in the suicidal
ideation module of the C-SSRS] or suicidal behavior per the investigator's clinical
judgment or based on the C-SSRS (corresponding to any score higher than 0 in the
suicidal behavior module of the C-SSRS)

- Participant has positive test result(s) for drugs of abuse (including barbiturates,
methadone, opiates, cocaine, phencyclidine, and amphetamine/methamphetamine) predose
on the day of the first intranasal treatment session

- Participant has any anatomical or medical condition that, per the investigator's
clinical judgment based on assessment, may impede delivery or absorption of intranasal
study drug

- Participant has taken any prohibited therapies that would not permit administration of
the first intranasal treatment session
We found this trial at
100
sites
24 Greenway Plaza
Houston, Texas 77046
?
mi
from
Houston, TX
Click here to add this to my saved trials
1000 Blythe Blvd
Charlotte, North Carolina 28203
(704) 355-2000
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
University of Chicago One of the world's premier academic and research institutions, the University of...
?
mi
from
Chicago, IL
Click here to add this to my saved trials
1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
?
mi
from
Houston, TX
Click here to add this to my saved trials
Minneapolis, Minnesota 55455
(612) 625-5000
Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials
1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
?
mi
from
Nashville, TN
Click here to add this to my saved trials
Allentown, Pennsylvania 18104
?
mi
from
Allentown, PA
Click here to add this to my saved trials
Anaheim, California 92805
?
mi
from
Anaheim, CA
Click here to add this to my saved trials
Arlington, Texas 76012
?
mi
from
Arlington, TX
Click here to add this to my saved trials
811 Juniper St NE
Atlanta, Georgia 30308
(404) 881-5800
Atlanta Center for Medical Research Welcome to the Atlanta Center for Medical Research, a leader...
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
Austin, Texas 78754
?
mi
from
Austin, TX
Click here to add this to my saved trials
Austin, Texas 78759
?
mi
from
Austin, TX
Click here to add this to my saved trials
Baltimore, Maryland 21208
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
Baltimore, Maryland 21287
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
1780 Félix de Azara
Banfield, B1828
?
mi
from
Banfield,
Click here to add this to my saved trials
1713 6th Avenue South
Birmingham, Alabama 35294
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
Boston, Massachusetts 02114
?
mi
from
Boston, MA
Click here to add this to my saved trials
Boston, Massachusetts 02135
?
mi
from
Boston, MA
Click here to add this to my saved trials
Bothell, Washington 98011
?
mi
from
Bothell, WA
Click here to add this to my saved trials
Bradenton, Florida
?
mi
from
Bradenton, FL
Click here to add this to my saved trials
900 Main Street
Brawley, California 92227
?
mi
from
Brawley, CA
Click here to add this to my saved trials
Burlingame, California 94010
?
mi
from
Burlingame, CA
Click here to add this to my saved trials
Cedarhurst, New York 11516
?
mi
from
Cedarhurst, NY
Click here to add this to my saved trials
Chapel Hill, North Carolina 27599
(919) 962-2211
Univ of North Carolina Carolina’s vibrant people and programs attest to the University’s long-standing place...
?
mi
from
Chapel Hill, NC
Click here to add this to my saved trials
171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
?
mi
from
Charleston, SC
Click here to add this to my saved trials
Charlottesville, Virginia 22903
?
mi
from
Charlottesville, VA
Click here to add this to my saved trials
?
mi
from
Charlottesville, VA
Click here to add this to my saved trials
1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
?
mi
from
Chicago, IL
Click here to add this to my saved trials
Chicago, Illinois 60634
?
mi
from
Chicago, IL
Click here to add this to my saved trials
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
2068 Orange Tree Lane
Colton, California 92374
?
mi
from
Colton, CA
Click here to add this to my saved trials
Dallas, Texas 78757
?
mi
from
Dallas, TX
Click here to add this to my saved trials
1801 Inwood Rd
Dallas, Texas 75390
(214) 645-3300
University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
?
mi
from
Dallas, TX
Click here to add this to my saved trials
12655 North Central Expressway
Dallas, Texas 75243
?
mi
from
Dallas, TX
Click here to add this to my saved trials
2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
?
mi
from
Durham, NC
Click here to add this to my saved trials
263 Farmington Ave
Farmington, Connecticut 06030
(860) 679-2000
University of Connecticut Health Center UConn Health is a vibrant, integrated academic medical center that...
?
mi
from
Farmington, CT
Click here to add this to my saved trials
Gainesville, Florida 32607
?
mi
from
Gainesville, FL
Click here to add this to my saved trials
Garden Grove, California 92845
?
mi
from
Garden Grove, CA
Click here to add this to my saved trials
Glendale, California 91204
?
mi
from
Glendale, CA
Click here to add this to my saved trials
Hartford, Connecticut 06106
?
mi
from
Hartford, CT
Click here to add this to my saved trials
Hickory, North Carolina 28601
?
mi
from
Hickory, NC
Click here to add this to my saved trials
1650 Moon Lake Boulevard
Hoffman Estates, Illinois 60169
?
mi
from
Hoffman Estates, IL
Click here to add this to my saved trials
Houston, Texas 77024
?
mi
from
Houston, TX
Click here to add this to my saved trials
?
mi
from
Iowa City, IA
Click here to add this to my saved trials
Joliet, Illinois 60435
?
mi
from
Joliet, IL
Click here to add this to my saved trials
Lake Charles, Louisiana 70601
?
mi
from
Lake Charles, LA
Click here to add this to my saved trials
640 George Washington Highway
Lincoln, Rhode Island 02865
?
mi
from
Lincoln, RI
Click here to add this to my saved trials
Little Rock, Arkansas 72211
?
mi
from
Little Rock, AR
Click here to add this to my saved trials
Maitland, Florida 32751
?
mi
from
Maitland, FL
Click here to add this to my saved trials
Marietta, Georgia 30060
?
mi
from
Marietta, GA
Click here to add this to my saved trials
2160 South 1st Avenue
Maywood, Illinois 60153
(888) 584-7888
Loyola University Medical Center Loyola University Health System is committed to excellence in patient care...
?
mi
from
Maywood, IL
Click here to add this to my saved trials
Media, Pennsylvania 19063
?
mi
from
Media, PA
Click here to add this to my saved trials
717 Ponce De Leon Boulevard
Miami, Florida 33134
?
mi
from
Miami, FL
Click here to add this to my saved trials
Miami, Florida 33165
?
mi
from
Miami, FL
Click here to add this to my saved trials
10555 West Flagler Street
Miami, Florida 33174
?
mi
from
Miami, FL
Click here to add this to my saved trials
1801 Coral Way
Miami, Florida 33133
?
mi
from
Miami, FL
Click here to add this to my saved trials
?
mi
from
Middleton, WI
Click here to add this to my saved trials
New Bedford, Massachusetts 02740
?
mi
from
New Bedford, MA
Click here to add this to my saved trials
New Haven, Connecticut 6520
(203) 432-4771
Yale University Yale's roots can be traced back to the 1640s, when colonial clergymen led...
?
mi
from
New Haven, CT
Click here to add this to my saved trials
New York, New York 10016
?
mi
from
New York, NY
Click here to add this to my saved trials
New York, New York 10019
?
mi
from
New York, NY
Click here to add this to my saved trials
622 West 168th Street
New York, New York 10032
?
mi
from
New York, NY
Click here to add this to my saved trials
New York, New York 10128
?
mi
from
New York, NY
Click here to add this to my saved trials
4132 Keaton Crossing Boulevard
O'Fallon, Missouri 63368
?
mi
from
O'Fallon, MO
Click here to add this to my saved trials
Oakland, California 94612
?
mi
from
Oakland, CA
Click here to add this to my saved trials
Oklahoma City, Oklahoma 73112
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
Oklahoma City, Oklahoma 73112
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
Oklahoma City, Oklahoma 73103
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
2500 California Plaza
Omaha, Nebraska 68102
(402) 280-2700
Creighton University Creighton University, located in Omaha, Neb., offers a top-ranked education in the Jesuit...
?
mi
from
Omaha, NE
Click here to add this to my saved trials
1010 West Chapman Avenue
Orange, California 92868
?
mi
from
Orange, CA
Click here to add this to my saved trials
Orlando, Florida 32806
?
mi
from
Orlando, FL
Click here to add this to my saved trials
Orlando, Florida 32803
?
mi
from
Orlando, FL
Click here to add this to my saved trials
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Prairie Village, Kansas 66206
?
mi
from
Prairie Village, KS
Click here to add this to my saved trials
345 Blackstone Blvd
Providence, Rhode Island 02906
?
mi
from
Providence, RI
Click here to add this to my saved trials
Quincy, Massachusetts 02169
?
mi
from
Quincy, MA
Click here to add this to my saved trials
?
mi
from
Roanoke, VA
Click here to add this to my saved trials
441 South Livernois Road
Rochester Hills, Michigan 48307
?
mi
from
Rochester Hills, MI
Click here to add this to my saved trials
Rockville, Maryland 20850
?
mi
from
Rockville, MD
Click here to add this to my saved trials
4801 Weldon Spring Parkway
Saint Charles, Missouri 63304
?
mi
from
Saint Charles, MO
Click here to add this to my saved trials
660 South Euclid Avenue
Saint Louis, Michigan 63110
?
mi
from
Saint Louis, MI
Click here to add this to my saved trials
San Diego, California 92093
?
mi
from
San Diego, CA
Click here to add this to my saved trials
San Diego, California 92123
?
mi
from
San Diego, CA
Click here to add this to my saved trials
San Marcos, California 92078
?
mi
from
San Marcos, CA
Click here to add this to my saved trials
1330 Lincoln Avenue
SAN RAFAEL, California 94901
(949) 683-1123
We are psychiatry clinic and a research facility based in San Rafael, California
?
mi
from
SAN RAFAEL, CA
Click here to add this to my saved trials
1375 Schaumburg Road
Schaumburg, Illinois 60194
?
mi
from
Schaumburg, IL
Click here to add this to my saved trials
Scranton, Pennsylvania 18503
?
mi
from
Scranton, PA
Click here to add this to my saved trials
?
mi
from
Shreveport, LA
Click here to add this to my saved trials
Skokie, Illinois 60076
?
mi
from
Skokie, IL
Click here to add this to my saved trials
4349 Hylan Boulevard
Staten Island, New York 10312
?
mi
from
Staten Island, NY
Click here to add this to my saved trials
101 Nicolls Rd
Stony Brook, New York 11794
(631) 444-4000
Stony Brook University Medical Center Stony Brook Medicine expresses our shared mission of research, clinical...
?
mi
from
Stony Brook, NY
Click here to add this to my saved trials
Tampa, Florida 33609
?
mi
from
Tampa, FL
Click here to add this to my saved trials
3515 East Fletcher Avenue
Tampa, Florida 33613
?
mi
from
Tampa, FL
Click here to add this to my saved trials
Watertown, Massachusetts
?
mi
from
Watertown, MA
Click here to add this to my saved trials
?
mi
from
Waukesha, WI
Click here to add this to my saved trials
1010 North Kansas Street
Wichita, Kansas 67214
?
mi
from
Wichita, KS
Click here to add this to my saved trials
Wichita, Kansas 67214
?
mi
from
Wichita, KS
Click here to add this to my saved trials
3300 Seymour Highway
Wichita Falls, Texas 76309
?
mi
from
Wichita Falls, TX
Click here to add this to my saved trials
21704 Maxham Meadow Way
Woodstock, Vermont 05091
?
mi
from
Woodstock, VT
Click here to add this to my saved trials
55 N Lake Ave
Worcester, Massachusetts 01655
(508) 856-8989
Univ of Massachusetts Med School As the commonwealth's only public medical school, we take seriously...
?
mi
from
Worcester, MA
Click here to add this to my saved trials