We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Long-term, Safety and Efficacy Study of Intranasal Esketamine in Treatment-resistant Depression (SUSTAIN-2)

This study is currently recruiting participants.
Verified October 2017 by Janssen Research & Development, LLC
Sponsor:
ClinicalTrials.gov Identifier:
NCT02497287
First Posted: July 14, 2015
Last Update Posted: October 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Janssen Research & Development, LLC
  Purpose
The purpose of this open-label, multicenter study is to assess the long term safety and efficacy of intranasal esketamine plus an oral antidepressant in participants with treatment-resistant depression (TRD).

Condition Intervention Phase
Treatment-resistant Depression Drug: Esketamine (Intranasal Spray) Drug: Duloxetine (Oral Antidepressant) Drug: Escitalopram (Oral Antidepressant) Drug: Sertraline (Oral Antidepressant) Drug: Venlafaxine Extended Release (XR) (Oral Antidepressant) Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Long-term, Safety and Efficacy Study of Intranasal Esketamine in Treatment-resistant Depression

Resource links provided by NLM:


Further study details as provided by Janssen Research & Development, LLC:

Primary Outcome Measures:
  • Change from baseline in Bladder Pain/ Interstitial Cystitis Symptom Score (BPIC-SS) score [ Time Frame: Baseline (Day 1) up to end of Follow Up phase (Week 56) ]
    Bladder Pain/ Interstitial Cystitis Symptom Score (BPIC-SS), is a scale to monitor for symptoms of cystitis, bladder pain, and interstitial cystitis.

  • Change from baseline in Cogstate computerized cognitive battery domains and Hopkins Verbal Learning Test-Revised (HVLT-R) [ Time Frame: Baseline (Day 1) up to end of Follow Up phase (Week 56) ]
    The cognitive battery will provide assessment of multiple cognitive domains, including attention, visual learning and memory, and executive function. The HVLT-R is a measure of verbal learning and memory.

  • Incidence of withdrawal symptoms assessed by Physician Withdrawal Checklist (PWC-20) [ Time Frame: Week 52 (end of optimization/maintenance phase) or Week 54 (week 2 of Follow Up phase) or Week 56 (week 4 of Follow Up phase) ]
    The PWC-20 is a 20-item questionnaire to assess potential development of discontinuation symptoms after stopping of study drug.


Secondary Outcome Measures:
  • Number of participants with Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: Day 1 post dose through end of Follow Up Phase (Week 56) ]
  • Change from baseline in Heart Rate [ Time Frame: Baseline of each dosing session (predose) up to the last post-dose measurement (40 minutes, 1 and 1.5 hours) from the start of Induction Phase to End of Optimization/Maintenance Phase (week 52) ]
    Change from baseline (predose) in heart rate will be assessed.

  • Change from Baseline in systolic and diastolic blood pressure [ Time Frame: Baseline of each dosing session (predose) up to the last post-dose measurement (40 minutes, 1 and 1.5 hours) from the start of Induction Phase to End of Optimization/Maintenance Phase (week 52) ]
    Change From Baseline (predose) in systolic and diastolic blood pressure will be assessed.

  • Change from Baseline in Respiratory rate [ Time Frame: Baseline of each dosing session (predose) up to the last post-dose measurement (40 minutes, 1 and 1.5 hours) from the start of Induction Phase to End of Optimization/Maintenance Phase (week 52) ]
    Change from Baseline in Respiratory rate (predose) will be assessed.

  • Change from Baseline in blood oxygen saturation [ Time Frame: Baseline of each dosing session (predose),up to the last post dose measurement (1.5 hours or longer) from the start of Induction Phase to End of Optimization/Maintenance Phase (week 52) ]
    Change From Baseline in Blood oxygen saturation (predose) will be assessed.

  • Change from Baseline in Modified Observer's Assessment of Alertness/Sedation (MOAAS) scale score [ Time Frame: Baseline of each dosing session (predose),up to the last post dose measurement (1.5 hours or longer) from the start of Induction Phase to End of Optimization/Maintenance Phase (week 52) ]
    Effects on alertness and sedation are measured using Modified Observer's Assessment of Alertness/Sedation (MOAAS) scale.

  • Change from Baseline in Brief Psychiatric Rating Scale Total Score [ Time Frame: Baseline of each dosing session (predose),up to the last post dose measurement (1.5 hours) from the start of Induction Phase to End of Optimization/Maintenance Phase (week 52) ]
    Potential psychosis-like effects are measured using Brief Psychiatric Rating Scale, positive-symptom subscale (BPRS+).

  • Change from Baseline in Clinician-Administered Dissociative States Scale (CADSS) total score [ Time Frame: Baseline of each dosing session (predose) , up to the last post-dose measurement (1.5 hours) from the start of Induction Phase to End of Optimization/Maintenance Phase (week 52) ]
    Dissociative symptoms are assessed using CADSS.

  • Change from Baseline in Columbia Suicide Severity Rating Scale (CSSRS) Score [ Time Frame: Baseline (Day 1) up to the End of Optimization/Maintenance Phase (week 52) ]
    Potential effects on suicidal ideation/behavior are evaluated with Columbia Suicide Severity Rating Scale (CSSRS).

  • Change from Baseline in Nasal Tolerability [ Time Frame: Baseline of each dosing session (predose) to 1-hour post-dose from the start of Induction Phase to End of Optimization/Maintenance Phase (week 52) ]
    Nasal tolerability will be assessed by a Nasal Tolerability Questionnaire.

  • Change from Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Score [ Time Frame: Baseline up to End of Induction Phase (Day 28) and end of Optimization/Maintenance Phase (Week 52) ]
    The MADRS is a clinician-rated scale designed to measure depression severity and detects changes due to antidepressant treatment.

  • Change from Baseline in Clinical Global Impression-Severity (CGI-S) score [ Time Frame: Baseline up to End of Optimization/Maintenance Phase (Week 52) ]
    The CGI-S evaluates the severity of psychopathology on a scale of 0 to 7.

  • Change from Baseline in Subject-reported Depressive Symptoms Using the Patient Health Questionnaire - 9 (PHQ-9) Total Score [ Time Frame: Baseline up to End of Optimization/Maintenance Phase (Week 52) ]
    The PHQ-9 is a 9-item scale used to assess depressive symptoms. The responses for each item are summed to provide a total score (range of 0 to 27) with higher scores indicating greater severity of depressive symptoms.

  • Change from Baseline in Subject-reported Generalized Anxiety Disorder (GAD-7) Score [ Time Frame: Baseline up to End of Optimization/Maintenance Phase (Week 52) ]
    The GAD-7 is a brief and validated measure of overall anxiety.

  • Change from Baseline in Subject-Reported Health-related Quality of Life and Health Status as Assessed by EuroQol-5 Dimension-5 Level (EQ-5D-5L) [ Time Frame: Baseline up to End of Optimization/Maintenance Phase (Week 52) ]
    The EQ-5D-5L is a standardized instrument for use as a measure of health outcome. It consists of the EQ-5D-5L descriptive system and the EQ visual analogue scale (EQ-VAS). The EQ-5D-5L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The EQ-VAS self-rating records the respondent's own assessment of his or her overall health status at the time of completion, on a scale of 0 to 100.

  • Change from Baseline in Subject-reported Functioning and Associated Disability as Assessed by the Sheehan Disability Scale (SDS) Total Score [ Time Frame: Baseline up to End of Optimization/Maintenance Phase (Week 52) ]
    The SDS is a subject-reported outcome measure and is a 5-item questionnaire which has been widely used and accepted for assessment of functional impairment and associated disability.

  • Percentage of participants with Response [ Time Frame: Baseline (Day 1) of Induction Phase up to End of Optimization/Maintenance Phase (Week 52 ) ]
    Percentage of participants with greater than or equal to (>=) 50% reduction from baseline (induction phase) in the MADRS total score and PHQ 9 total score will be reported.

  • Percentage of participants with Remission [ Time Frame: Baseline (Day 1) of Induction Phase up to End of Optimization/Maintenance Phase (Week 52 ) ]
    Percentage of participants with MADRS total score less than or equal to (<=) 12 will be reported.


Other Outcome Measures:
  • Change from baseline in hematology, biochemistry and urinalysis parameters [ Time Frame: Baseline to Follow up (week 56) ]
    Safety parameters

  • Change from Baseline in Electrocardiogram (ECG) intervals [ Time Frame: Baseline up to the last post-dose measurement (1 hour) from the start of Induction Phase to End of Optimization/Maintenance Phase (week 52) ]
    Safety parameters

  • Number of participants with suicidal ideations with some intent to act based on Columbia Suicide Severity Rating Scale (CSSRS) [ Time Frame: Baseline (Day 1) up to End of Optimization/Maintenance Phase (week 52) ]
    Potential effects on suicidal ideation/behavior are evaluated with Columbia Suicide Severity Rating Scale (CSSRS).


Estimated Enrollment: 750
Actual Study Start Date: September 30, 2015
Estimated Study Completion Date: October 31, 2017
Estimated Primary Completion Date: October 31, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intranasal Esketamine plus oral antidepressant
Open-Label Induction Phase: Participants will self-administer esketamine intranasally twice per week for 4 weeks as a flexible dose regimen (56 mg or 84 mg). Participants greater than or equal to (>=) 65 will start at a dose of 28 mg on Day 1. Direct-entry participants will initiate a new, open-label oral antidepressant (duloxetine, escitalopram, sertraline, or venlafaxine extended release [XR]) on Day 1; transferred-entry participants will continue the same oral antidepressant from ESKETINTRD3005. Optimization/Maintenance Phase: Participants will self-administer esketamine (56mg or 84mg for those < 65 years; 28 mg, 56 mg or 84 mg for those >= 65 years) intranasally once per week for 4 weeks; transferred entry responder subjects from ESKETINTRD3005 will start at a dose of 28 mg in the first week. All participants will continue their same oral antidepressant during this phase.
Drug: Esketamine (Intranasal Spray)
Open-Label Induction Phase: Participants will self-administer esketamine intranasally twice per week for 4 weeks as a flexible dose regimen (56 mg or 84 mg for those < 65 years; 28 mg, 56 mg or 84 mg for those >= 65 years). Participants >= 65 years old will start at a dose of 28 mg on Day 1. Optimization/Maintenance Phase: Participants will self-administer esketamine intranasally (56 mg or 84 mg for those < 65 years; 28 mg, 56 mg or 84 mg for those >= 65 years) once weekly then individualized to either once weekly or once every other week based on the severity of depressive symptoms. Transferred-entry responder participants from ESKETINTRD3005 >= 65 years old will start at a dose of 28 mg in Week 5.
Drug: Duloxetine (Oral Antidepressant)
Duloxetine could be selected as the oral antidepressant medication by the investigator based on review of Massachusetts General Hospital - Antidepressant Treatment Response Questionnaire (MGH-ATRQ) and relevant prior antidepressant medication information. The minimum therapeutic dose is 60 milligram per day (mg/day).
Drug: Escitalopram (Oral Antidepressant)
Escitalopram could be selected as the oral antidepressant medication by the investigator based on review of MGH-ATRQ and relevant prior antidepressant medication information. The minimum therapeutic dose is 10 mg/day. Participants >= 65 years of age will be titrated up to 20 mg/day, but can lower the dose to 10 mg/day for tolerability.
Drug: Sertraline (Oral Antidepressant)
Sertraline could be selected as the oral antidepressant medication by the investigator based on review of MGH-ATRQ and relevant prior antidepressant medication information. Sertraline will be titrated up to a dose of 150 mg/day, but if not tolerated the dose can be reduced to the minimum therapeutic dose of 50 mg/day.
Drug: Venlafaxine Extended Release (XR) (Oral Antidepressant)
Venlafaxine Extended Release could be selected as the oral antidepressant medication by the investigator based on review of MGH-ATRQ and relevant prior antidepressant medication information. Venlafaxine Extended Release will be titrated for participants < 65 years of age up to a dose of 225 mg/day, but if not tolerated the dose can be reduced to the minimum therapeutic dose of 150 mg/day. For participants >= 65, it can be titrated up to a dose of 150 mg/day, but if not tolerated the dose can be reduced to the minimum therapeutic dose of 75 mg/day.

Detailed Description:
This is an open-label (the researchers and participants know the treatment the participant is receiving), multicenter (more than 1 study site), long-term safety and efficacy study of intranasal esketamine plus an oral antidepressant in participants with treatment-resistant depression (TRD). Participants will enter the study either directly (direct-entry participants) or after completing the Double-Blind Induction Phase of ESKETINTRD3005 (transferred-entry participants). The study consists of 4 phases: Screening Phase (4 weeks), Open-Label Induction Phase (4 weeks), Open-Label Optimization/Maintenance phase (48 weeks), and Follow up Phase (4 weeks). Transferred entry non-responders in the ESKETINTRD3005 may enter study at the Open-Label Induction Phase and responders in the ESKETINTRD3005 may enter Optimization/Maintenance phase. In the Open-Label Induction Phase, participants will self-administer flexibly-dosed intranasal esketamine (participants who are less than (<) 65 years old self-administer 56 mg or 84 mg dose, participants who are greater than or equal to (>=) 65 years old self-administer 28 mg, 56 mg or 84 mg dose) twice weekly for 4 weeks. The starting dose for all participants >= 65 years old will be 28 mg. In addition, each direct-entry participants will be assigned to receive 1 of 4 selected oral antidepressant medications (escitalopram or sertraline or duloxetine or venlafaxine extended release [XR]), initiated on Day 1 of the open-label induction phase and continued through the duration of the study. Transferred-entry participants will continue their same antidepressant from ESKETINTRD3005 through the duration of this study. Participants who are responders at the end of the Open-Label Induction phase and transferred-entry responder participants (from study ESKETINTRD3005) will enter the Optimization/Maintenance Phase where intranasal esketamine treatment sessions will be reduced from that in the induction phase (twice weekly) to weekly for the first 4 weeks of this phase, and then individualized to either once weekly or once every other week based on the severity of depressive symptoms. Participants' safety and depressive symptoms will be assessed and monitored throughout the study.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

A). For Direct-Entry Participants

  • At the time of signing the informed consent form (ICF), participant must be a man or woman ≥18 (or older if the minimum legal age of consent in the country in which the study is taking place is greater than [>]18)
  • At the start of the screening phase, participant must meet the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) diagnostic criteria for single-episode major depressive disorder (MDD) (if single-episode MDD, the duration must be greater than or equal to [>=] 2 years) or recurrent MDD, without psychotic features, based upon clinical assessment and confirmed by the Mini-International Neuropsychiatric Interview (MINI)
  • At screening, participant must have a MADRS total score of >=22
  • At the start of the screening phase, participants must have had nonresponse to >=2 oral antidepressant treatments in the current episode of depression, as assessed using the the MGHATRQ and confirmed by documented records (example medical/pharmacy/prescription records or a letter from treating a physician, etc,) B). For Transferred-entry Participants
  • All participants who completed the double-blind induction phase of ESKETINTRD3005 study, regardless of their response status, will be eligible to participate in this study, if they meet the study specific eligibility criteria

Exclusion Criteria:

A). For Direct-Entry Participants

  • Participant's depressive symptoms have previously not responded to: Esketamine or ketamine in the current major depressive episode per clinical judgment or All of the 4 oral antidepressant treatment options available in the respective country for the open-label induction phase (that is, duloxetine, escitalopram, sertraline, and venlafaxine XR) in the current major depressive episode (based on Massachusetts General Hospital - Antidepressant Treatment Response Questionnaire [ MGH-ATRQ])
  • Participant has a current or prior DSM-5 diagnosis of a psychotic disorder or MDD with psychotic features, bipolar or related disorders (confirmed by the MINI), obsessive compulsive disorder (current only), intellectual disability (DSM-5 diagnostic codes 317, 318.0, 318.1, 318.2, 315.8, and 319), autism spectrum disorder, borderline personality disorder, antisocial personality disorder, histrionic personality disorder, or narcissistic personality disorder
  • Participant has homicidal ideation/intent, per the investigator's clinical judgment, or has suicidal ideation with some intent to act within 6 months prior to the start of the screening phase, per the investigator's clinical judgment or based on the Columbia Suicide Severity Rating Scale (C-SSRS)
  • Participants with history of moderate or severe substance or alcohol use disorder according to DSM-5 criteria
  • Participants who has a Mini Mental State Examination (MMSE) <25; Has neurodegenerative disorder (example, Alzheimer's disease, vascular dementia, Parkinson's disease), or evidence of mild cognitive impairment (MCI) B). Transferred-Entry Participants
  • Participant has taken any prohibited therapies that would not permit dosing on Day 1
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02497287


Contacts
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: JNJ.CT@sylogent.com

  Hide Study Locations
Locations
United States, California
Sharp Mesa Vista Hospital Withdrawn
San Diego, California, United States, 92123
United States, Connecticut
University of Connecticut Health Center Withdrawn
Farmington, Connecticut, United States, 06030-6415
Yale University Completed
New Haven, Connecticut, United States, 06511
United States, Florida
Osceola Mental Health D/B/A Park Place Behavioral Health Care Withdrawn
Kissimmee, Florida, United States, 34741
Innova Clinical Trials Completed
Miami, Florida, United States, 33133
United States, Georgia
Northwest Behavioral Research Center Completed
Marietta, Georgia, United States, 30060
United States, Illinois
University of Chicago Withdrawn
Chicago, Illinois, United States, 60637
Capstone Clinical Research Withdrawn
Libertyville, Illinois, United States, 60048
United States, Iowa
University of Iowa, Carver College of Medicine Completed
Iowa City, Iowa, United States, 52242
United States, Kansas
Via Christi Hospitals Wichita, Inc Completed
Wichita, Kansas, United States, 67214
United States, Louisiana
Biomedical Research Foundation of Northwest Louisiana Withdrawn
Shreveport, Louisiana, United States, 71104-2136
United States, Maryland
Pharmasite Research, Inc. Active, not recruiting
Baltimore, Maryland, United States, 21208
United States, Massachusetts
Massachusetts General Withdrawn
Boston, Massachusetts, United States, 2114
Adams Clinical Trials, LLC Active, not recruiting
Watertown, Massachusetts, United States, 02472
United States, Michigan
Washington University School of Medicine Withdrawn
Saint Louis, Michigan, United States, 63110
United States, New York
Neurobehavioral Research, Inc Completed
Cedarhurst, New York, United States, 11516
Clinilabs Completed
New York, New York, United States, 10019
Northwell Health Withdrawn
New York, New York, United States, 11004
Richmond Behavioural Associates Completed
Staten Island, New York, United States, 10312
United States, Ohio
University of Cincinnati, Dept of Psychiatry & Behavioral Neuroscience Active, not recruiting
Cincinnati, Ohio, United States, 45219
United States, Pennsylvania
Lehigh Center for Clinical Research Completed
Allentown, Pennsylvania, United States, 18104
University of Pennsylvania Withdrawn
Philadelphia, Pennsylvania, United States, 19104
United States, South Carolina
Medical University of South Carolina Completed
Charleston, South Carolina, United States, 29425
United States, Tennessee
Vanderbilt University School of Medicine Withdrawn
Nashville, Tennessee, United States, 37203
United States, Texas
Relaro Medical Trials Completed
Dallas, Texas, United States, 75243
Grayline Research Center Completed
Wichita Falls, Texas, United States, 76309
United States, Virginia
Psychiatric Alliance of the Blue Ridge, Inc. Withdrawn
Charlottesville, Virginia, United States, 22903-4801
United States, Washington
Zain Research LLC Completed
Richland, Washington, United States, 99352
Argentina
Clínica Privada Banfield S.A Completed
Banfield, Argentina, B1828CKR
CENydET - Centro Neurobiologico y de Stress Traumatico Withdrawn
Buenos Aires, Argentina, 1058AAJ
Instituto Seres Completed
Buenos Aires, Argentina, 1111
IPEM Completed
Buenos Aires, Argentina, CA1115AAJ
Instituto Nacional de Psicopatología Active, not recruiting
Ciudad Autonoma De Buenos Aires, Argentina, C1405BOA
Fundación para el Estudio y Tratamiento de las Enfermedades Mentales Active, not recruiting
Ciudad Autonoma De Buenos Aires, Argentina, C1425AHQ
Instituto DAMIC Completed
Cordoba, Argentina, X5003DCE
CEN Active, not recruiting
Cordoba, Argentina, X5004FJF
Sanatorio Prof. Leon S. Morra Active, not recruiting
Cordoba, Argentina, X5009BIN
Instituto de Neurociencias San Agustín Active, not recruiting
La Plata, Argentina, 1900
CENPIA Withdrawn
La Plata, Argentina, 1902
Clinica Privada de Salud Mental Santa Teresa de Ávila Active, not recruiting
La Plata, Argentina, B1904ADM
CENAIN Active, not recruiting
Mendoza, Argentina, M5502AWI
C.I.A.P. (Centro de investigación y Asistencia en Psiquiatría) Active, not recruiting
Rosario, Argentina, 2000
Australia
The Lyell McEwin Hospital Completed
Adelaide, Australia, 5112
Monash Alfred Psychiatry Research Centre Completed
Caulfield, Australia, 3162
Peninsula Therapeutic & Research Group Completed
Frankston, Australia, 3199
Caulfield Hospital Completed
Melbourne, Australia, 3162
Frankston Hospital Completed
Melbourne, Australia, 3199
Sir Charles Gairdner Hospital Withdrawn
Perth, Australia, 6009
Austria
Medical University Innsbruck Completed
Innsbruck, Austria, 6020
Schmitz and Schmitz Completed
Vienna, Austria, 1010
Medical University Vienna, MUV Completed
Vienna, Austria, 1090
Belgium
OLV Research Unit Aalst Withdrawn
Aalst, Belgium, 9300
AZ St.-Jan Brugge-Oostende AV Completed
Brugge, Belgium, 8000
UZ Brussel Withdrawn
Brussel, Belgium, 1090
Virga Jessa Ziekenhuis Completed
Hasselt, Belgium, 3500
Sint-Franciskusziekenhuis Withdrawn
Heusden-Zolder, Belgium, 3550
ISoSL - Site Pèrî Withdrawn
Liège, Belgium, 4000
Brazil
Kraepelin Psiquiatria Clinica Withdrawn
Belo Horizonte, Brazil, 30130-100
CPN Centro De Pesquisas EM Neurociencia Recruiting
Belo Horizonte, Brazil, 30150-270
Instituto de Neurologia de Curitiba Withdrawn
Curitiba, Brazil, 81210-310
Universidade Federal Do Ceara Recruiting
Fortaleza, Brazil, 60430-370
Bioserv SMO - HSVP ( Hospital São Vicente de Paulo) Withdrawn
Passo Fundo, Brazil, 99010-080
Hospital de Clínicas de Porto Alegre Withdrawn
Porto Alegre, Brazil, 90035-003
Universidade De Pernambuco Faculdade De Ciencias Medicas De Pernambuco Completed
Recife, Brazil, 50100-130
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto - USP Withdrawn
Ribeirão Preto, Brazil, 14049-800
UFRJ - Instituto de Psiquiatria Recruiting
Rio De Janeiro, Brazil, 22210-030
Centro de Psiquiatria e Pesquisas Sandra Ruschel Active, not recruiting
Rio De Janeiro, Brazil, 22270-060
Hospital Estadual Mario covas Recruiting
Santo André, Brazil, 09190-615
Fundacao Faculdade Regional De Medicina De Sao Jose Do Rio Preto Recruiting
São José Do Rio Preto, Brazil, 15015-500
Neurotrials - MW Health and Behavior Withdrawn
São Paulo, Brazil, 03066-070
Proesq - Unifesp Completed
São Paulo, Brazil, 04044-000
Clinica Dr. Norton Sayeg Completed
São Paulo, Brazil, 04063-000
Instituto Proter HCFMUSP Suspended
São Paulo, Brazil, 05403-010
Bulgaria
Mental Health Center Prof. Dr. Ivan Temkov Completed
Bourgas, Bulgaria, 8001
State Psychiatric Hospital Kardzhali Completed
Kardzhali, Bulgaria, 6600
Multiprofile Hospital for Active Treatment dr. Hristo Stambolski EOOD Completed
Kazanlak, Bulgaria, 6100
State Psychiatric Hospital Pazardzhik Completed
Pazardzhik, Bulgaria, 4400
University Multiprofile Hospital for Active Treatment Dr. Georgi Stranski Active, not recruiting
Pleven, Bulgaria, 5800
UMHAT 'Sveti Georgi'-Plovdiv Completed
Plovdiv, Bulgaria, 4002
Mental Health Center - Rousse Completed
Rousse, Bulgaria, 7003
Medical Center St. Naum Completed
Sofia, Bulgaria, 1113
Multiprofile Hospital for Active Treatment in Neurology and Psychiatry Sveti Nuam Withdrawn
Sofia, Bulgaria, 1113
Centre for Mental Health Prof.N.Shipkovenski EOOD Completed
Sofia, Bulgaria, 1377
University Multiprofile Hospital for Active Treatment Alexandrovska EAD Completed
Sofia, Bulgaria, 1431
Military Medical Academy Completed
Sofia, Bulgaria, 1606
Multiprofile Hospital for Active Treatment - Doverie Completed
Sofia, Bulgaria, 1632
City Clinic Medical Center Bregalnitsa EOOD Withdrawn
Varna, Bulgaria, 9002
Diagnostic Consulting Center Mladost - M Varna Completed
Varna, Bulgaria, 9020
Diagnostic Consulting Center Mladost - M Varna Recruiting
Varna, Bulgaria, 9020
Finland
Mederon LTD at ARTES Completed
Helsinki, Finland, 00270
Savon Psykiatripalvelu Completed
Kuopio, Finland, 70110
France
Hôpital Corentin-Celton Withdrawn
Issy-Les-Moulineaux, France, 92130
CHU Grenoble, Pôle de Psychiatrie, Neurologie et Rééducation Withdrawn
La Tronche, France, 38700
Hopital PASTEUR Withdrawn
Nice, France, 06001
CHU Caremeau Withdrawn
Nimes Cedex 9, France, 30029
Hopital Sainte Anne Completed
Paris, France, 75014
CH Henri Laborit Completed
Poitiers, France, 86021
Hôpital Sainte Musse Completed
Toulon, France, 83100
CHU Toulouse Withdrawn
Toulouse, France, 31059
CHRU Tours Hôpital Bretonneau Completed
Tours Cedex 9, France, 37044
Germany
Emovis GmbH Completed
Berlin, Germany, 10629
Praxis Completed
Bochum, Germany, 44787
Praxisgemeinschaft für Neurologie, Psychiatrie und Psychotherapie Completed
Bochum, Germany, 44892
Psychiatrie Praxis Dr. Frank Kühn Arzt für Psychiatrie und Psychotherapie Completed
Oranienburg-Sachsenhausen, Germany, 16515
Korea, Republic of
Korea University Ansan Hospital Completed
Ansan-Si, Korea, Republic of, 425-707
Chonnam National University Hospital Completed
Gwangju, Korea, Republic of, 61469
Kyung Hee University Medical Center Completed
Seoul, Korea, Republic of, 02447
Seoul National University Hospital Completed
Seoul, Korea, Republic of, 03080
Severance Hospital Withdrawn
Seoul, Korea, Republic of, 03722
Samsung Medical Center Completed
Seoul, Korea, Republic of, 06351
Korea University Anam Hospital Completed
Seoul, Korea, Republic of, 136-705
The Catholic University Of Korea St Mary'S Hospital Withdrawn
Seoul, Korea, Republic of, 150-713
Lithuania
Romuvos Klinika, JSC Recruiting
Kaunas, Lithuania, 44279
Neuromeda, JSC Recruiting
Kaunas, Lithuania, 50185
Silutes Mental health and psychotherapy center, JSC Recruiting
Silute, Lithuania, 99142
Antakalnis Psychiatric Consultation Centre, Public Institution Recruiting
Vilnius, Lithuania, 10204
Vilnius Mental Health Center Withdrawn
Vilnius, Lithuania, 10309
Malaysia
UniKL Royal College of Medicine Perak Active, not recruiting
Ipoh, Malaysia, 30450
Hospital Bahagia Ulu Kinta Completed
Ipoh, Malaysia, 31250
Hospital Permai Completed
Johor Bahru, Malaysia, 81200
Hospital Kuala Lumpur Completed
Kuala Lumpur, Malaysia, 50586
University Malaya Medical Centre Completed
Kuala Lumpur, Malaysia, 50603
Mexico
Centro de Investigación Clínica del Pacífico Completed
Acapulco, Mexico, 39670
Instituto de Investigación en Pro de la Salud Mental Completed
Durango, Mexico, 34000
Clinica Cemelli Withdrawn
Guadalajara, Mexico, 04410
Investigación Biomédica Elemental S.A.P.I de C.V.I Withdrawn
Guadalajara, Mexico, 44890
INCIDE Completed
Mexico City, Mexico, 11006
Centro de Estudios Clinicos y Especialidades Medicas, S.C. Active, not recruiting
Mexico, Mexico, 66400
Instituto Neuropsique Withdrawn
Monterrey, Mexico, 64610
Infosame/Research Completed
Monterrey, Mexico, 64710
IPSAME Withdrawn
Monterrey, Mexico, 66220
Hospital San José Withdrawn
Queretaro, Mexico, 76820
Centro de Atención e Investigación Cardiovascular del Potosí, S.C. Withdrawn
San Luis Potosí, Mexico, 78200
Poland
Gabinet Lekarski Ireneusz Kaczorowski Withdrawn
Belchatow, Poland, 97-400
Clinsante Osrodek Badan Klinicznych Withdrawn
Bydgoszcz, Poland, 85-794
PI-House Completed
Gdansk, Poland, 80-546
Uniwersyteckie Centrum Kliniczne Klinika Chorob Psychicznych i Zaburzen Nerwicowych Completed
Gdansk, Poland, 80-952
ID Clinic Withdrawn
Myslowice, Poland, 41-400
Specjalistyczny Gabinet Psychiatryczny Kowalkowski Gerard Withdrawn
Torun, Poland, 87-100
NZOZ Prywatna Klinika Psychiatryczna INVENTIVA Withdrawn
Tuszyn, Poland, 95-080
South Africa
Flexivest 14 Research Completed
Cape Town, South Africa, 7550
David Dennis - Western Cape South Africa Withdrawn
Cape Town, South Africa, 7708
Juan Schrönen - Western Cape South Africa Completed
Cape Town, South Africa, 7735
Gert Bosch - Pretoria South Africa Completed
Garsfontein, South Africa, 00 45
Dr J C van der Westhuizen Withdrawn
George, South Africa, 6529
Karien Botha - Western Cape South Africa Withdrawn
Paarl, South Africa, 7646
Weskoppies Hospital Research Unit Active, not recruiting
Pretoria, South Africa, 00 01
Henriette Smit - North West South Africa Withdrawn
Wilkoppies, South Africa, 2570
Spain
Hosp. Univ. Infanta Cristina Recruiting
Badajoz, Spain, 06080
Hosp. Univ. de Basurto Completed
Bilbao, Spain, 48013
Hosp. Gral. Univ. de Elche Withdrawn
Elche, Spain, 03203
Hosp. Univ. Infanta Leonor Completed
Madrid, Spain, 28031
Hosp. Univ. Ramon Y Cajal Completed
Madrid, Spain, 28034
Hosp. Univ. Del Henares Completed
Madrid, Spain, 28822
Complexo Hosp. Univ. de Ourense Recruiting
Ourense, Spain, 32005
Centro Salud Mental La Corredoria Active, not recruiting
Oviedo, Spain, 33011
Benito Menni Comp. Asist. Salut Mental Active, not recruiting
Sant Boi De Llobregat, Spain, 08830
Hosp. Univ. de Torrevieja Completed
Torrevieja, Spain, 03186
Hosp. Clinico Univ. de Valencia Completed
Valencia, Spain, 46010
Hosp. Prov. de Zamora Completed
Zamora, Spain, 49021
Sweden
Su Psykiatri Affektiva Completed
Goteborg, Sweden, SE-42490
Affecta Pskyiatrimottagning Completed
Halmstad, Sweden, SE-30248
ProbarE i Lund AB Completed
Lund, Sweden, 22222
Läkarmottagningen Completed
Skövde, Sweden, 541 50
ProbarE i Stockholm AB Completed
Stockholm, Sweden, 17145
Karolinska Trial Alliance, KTA prim Completed
Stockholm, Sweden, SE-11361
Psykiatriska kliniken NUS Completed
Umea, Sweden, SE-90185
Taiwan
Chang Gung Memorial Hospital Completed
Kaohsiung, Taiwan, 83301
Taipei Medical University Shuang Ho Hospital Completed
New Taipei City, Taiwan, 23561
Chung Shan Medical University Hospital Completed
Taichung, Taiwan, 40201
National Cheng Kung University Hospital Completed
Tainan, Taiwan, 70403
Mackay Memorial Hospital Completed
Taipei, Taiwan, 10449
Taipei Veterans General Hospital Completed
Taipei, Taiwan, 11217
Chang Gung Memorial Hospital Completed
Taoyuan County, Taiwan, 333
Turkey
Dışkapı Yıldırım Beyazıd Training and Research Hospital Completed
Ankara, Turkey, 06330
Ataturk Training and Research Hospital Completed
Ankara, Turkey, 06800
Uludag University Medical Faculty Completed
Bursa, Turkey, 16285
Dicle University Medical Faculty Withdrawn
Diyarbakır, Turkey, 21080
Gaziantep University Sahinbey Research and Training Hospital Completed
Gaziantep, Turkey, 27310
Istanbul University Cerrahpasa Medical Faculty Withdrawn
Istanbul, Turkey, 34098
Bagcilar Training and Research Hospital Completed
Istanbul, Turkey, 34100
Haydarpasa Numune Training and Research Hospital Completed
Istanbul, Turkey, 34668
Marmara University Medical Faculty Completed
Istanbul, Turkey, 34854
Kocaeli University Medical Faculty Completed
Kocaeli, Turkey, 41380
Celal Bayar University Medical Faculty Hospital Completed
Manisa, Turkey, 34768
United Kingdom
Callington Road Hospital Completed
Bristol, United Kingdom, BS4 5BJ
Fulbourne Hospital Withdrawn
Cambridge, United Kingdom, CB21 5FE
Abraham Cowley Unit Withdrawn
Chertsey, United Kingdom, KT16 0AE
Ashgate Medical Practice Completed
Chesterfield, United Kingdom, S40 4AA
Royal Derby Hospital Completed
Derby, United Kingdom, DE22 3WG
NHS Greater Glasgow and Clyde Withdrawn
Glasgow, United Kingdom, G53 7TU
ADHD and Mental Health Unit Withdrawn
Horsham, United Kingdom, RH12 1RJ
Clinical Research Facility Completed
London, United Kingdom, SE5 9PJ
South West London & St George's Mental Health NHS Trust Withdrawn
London, United Kingdom, SW17 7DJ
Manchester Royal Infirmary Withdrawn
Manchester, United Kingdom, M13 9WL
Tees Esk and Wear Valleys NHS FT Completed
Middlesbrough, United Kingdom, TS4 3AF
Northamptonshire Healthcare NHS FT Completed
Northampton, United Kingdom, NN5 6UD
Nottingham City Hospital Withdrawn
Nottingham, United Kingdom, NG5 1PB
Warneford Hospital, NIHR Clinical Research Facility Completed
Oxford, United Kingdom, OX3 7JR
Royal Preston Hospital Completed
Preston, United Kingdom, PR2 9HT
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
  More Information

Additional Information:
Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT02497287     History of Changes
Other Study ID Numbers: CR107148
ESKETINTRD3004 ( Other Identifier: Janssen Research & Development, LLC )
2014-004587-38 ( EudraCT Number )
First Submitted: May 18, 2015
First Posted: July 14, 2015
Last Update Posted: October 24, 2017
Last Verified: October 2017

Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Janssen Research & Development, LLC:
Treatment-resistant Depression
Esketamine
Oral Antidepressant

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Treatment-Resistant
Behavioral Symptoms
Mood Disorders
Mental Disorders
Antidepressive Agents
Citalopram
Duloxetine Hydrochloride
Sertraline
Venlafaxine Hydrochloride
Dexetimide
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Serotonin and Noradrenaline Reuptake Inhibitors