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

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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
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...
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1000 Blythe Blvd
Charlotte, North Carolina 28203
(704) 355-2000
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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...
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1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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Minneapolis, Minnesota 55455
(612) 625-5000
Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
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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...
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Allentown, Pennsylvania 18104
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Anaheim, California 92805
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Arlington, Texas 76012
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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...
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Austin, Texas 78754
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Austin, Texas 78759
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Baltimore, Maryland 21208
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Baltimore, Maryland 21287
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1780 Félix de Azara
Banfield, B1828
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1713 6th Avenue South
Birmingham, Alabama 35294
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Boston, Massachusetts 02114
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Boston, Massachusetts 02135
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Bothell, Washington 98011
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Bradenton, Florida
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900 Main Street
Brawley, California 92227
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Burlingame, California 94010
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Cedarhurst, New York 11516
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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...
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Charlottesville, Virginia 22903
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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...
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Chicago, Illinois 60634
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2068 Orange Tree Lane
Colton, California 92374
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Dallas, Texas 78757
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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...
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12655 North Central Expressway
Dallas, Texas 75243
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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...
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263 Farmington Ave
Farmington, Connecticut 06030
(860) 679-2000
University of Connecticut Health Center UConn Health is a vibrant, integrated academic medical center that...
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Gainesville, Florida 32607
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Garden Grove, California 92845
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Glendale, California 91204
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Hartford, Connecticut 06106
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Hickory, North Carolina 28601
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1650 Moon Lake Boulevard
Hoffman Estates, Illinois 60169
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Houston, Texas 77024
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24 Greenway Plaza
Houston, Texas 77046
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Joliet, Illinois 60435
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Lake Charles, Louisiana 70601
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640 George Washington Highway
Lincoln, Rhode Island 02865
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Little Rock, Arkansas 72211
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Maitland, Florida 32751
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Marietta, Georgia 30060
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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...
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Media, Pennsylvania 19063
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717 Ponce De Leon Boulevard
Miami, Florida 33134
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Miami, Florida 33165
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10555 West Flagler Street
Miami, Florida 33174
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1801 Coral Way
Miami, Florida 33133
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New Bedford, Massachusetts 02740
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New Haven, Connecticut 6520
(203) 432-4771
Yale University Yale's roots can be traced back to the 1640s, when colonial clergymen led...
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New York, New York 10016
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New York, New York 10019
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622 West 168th Street
New York, New York 10032
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New York, New York 10128
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4132 Keaton Crossing Boulevard
O'Fallon, Missouri 63368
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Oakland, California 94612
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Oklahoma City, Oklahoma 73112
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Oklahoma City, Oklahoma 73112
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Oklahoma City, Oklahoma 73103
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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...
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1010 West Chapman Avenue
Orange, California 92868
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Orlando, Florida 32806
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Orlando, Florida 32803
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Prairie Village, Kansas 66206
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345 Blackstone Blvd
Providence, Rhode Island 02906
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Quincy, Massachusetts 02169
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441 South Livernois Road
Rochester Hills, Michigan 48307
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Rockville, Maryland 20850
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4801 Weldon Spring Parkway
Saint Charles, Missouri 63304
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660 South Euclid Avenue
Saint Louis, Michigan 63110
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San Diego, California 92093
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San Diego, California 92123
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San Marcos, California 92078
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San Rafael, California 94901
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1375 Schaumburg Road
Schaumburg, Illinois 60194
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Scranton, Pennsylvania 18503
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Skokie, Illinois 60076
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4349 Hylan Boulevard
Staten Island, New York 10312
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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...
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Tampa, Florida 33609
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3515 East Fletcher Avenue
Tampa, Florida 33613
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Watertown, Massachusetts
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1010 North Kansas Street
Wichita, Kansas 67214
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Wichita, Kansas 67214
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3300 Seymour Highway
Wichita Falls, Texas 76309
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21704 Maxham Meadow Way
Woodstock, Vermont 05091
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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...
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