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
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New York, New York 10016
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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
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1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
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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
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Burlingame, California 94010
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Cedarhurst, New York 11516
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Chapel Hill, North Carolina 27599
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Univ of North Carolina Carolina’s vibrant people and programs attest to the University’s long-standing place...
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171 Ashley Avenue
Charleston, South Carolina 29425
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Charlottesville, Virginia 22903
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1653 W. Congress Parkway
Chicago, Illinois 60612
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Chicago, Illinois 60634
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2068 Orange Tree Lane
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12655 North Central Expressway
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Durham, North Carolina 27710
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263 Farmington Ave
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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
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Lake Charles, Louisiana 70601
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640 George Washington Highway
Lincoln, Rhode Island 02865
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2160 South 1st Avenue
Maywood, Illinois 60153
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Media, Pennsylvania 19063
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717 Ponce De Leon Boulevard
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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
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New York, New York 10019
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622 West 168th Street
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New York, New York 10128
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Oakland, California 94612
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Oklahoma City, Oklahoma 73103
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2500 California Plaza
Omaha, Nebraska 68102
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1010 West Chapman Avenue
Orange, California 92868
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345 Blackstone Blvd
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Quincy, Massachusetts 02169
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441 South Livernois Road
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660 South Euclid Avenue
Saint Louis, Michigan 63110
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1330 Lincoln Avenue
SAN RAFAEL, California 94901
(949) 683-1123
We are psychiatry clinic and a research facility based in San Rafael, California
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1375 Schaumburg Road
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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
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Tampa, Florida 33609
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3515 East Fletcher Avenue
Tampa, Florida 33613
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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
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