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

NCT02782104 | Completed Phase 3 Results DMC

• 3 other identifiers: CR10814954135419TRD30082015-003578-34
• Study Type: interventional
• Target: 1,148
• Locations: 24 countries
• Sites: 170

Brief Summary

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

Conditions

Depressive Disorder, Treatment-Resistant

Keywords

Depressive Disorder, Treatment-Resistant; Esketamine; JNJ-54135419

Outcome Measures

Primary Outcomes (12)

• Change From Study Baseline in Computerized Cognitive Battery Domain Score: Detection Test (DET) Score

  This battery is a series of computerized cognition tests (detection, identification, one card learning, one back and groton maze learning) designed to measure reaction time, visual learning and memory, and executive function/sequencing. The DET is a measure of psychomotor function and uses a well-validated simple reaction time. In this outcome measure, speed of performance of subjects (calculated as mean of the logarithmic base 10 transformed reaction times) for correct responses was reported. Total score ranged from 2 to 3.3 log 10 milliseconds (msec). Lower score indicated better performance. Higher change from baseline indicated better performance.

  IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months

• Change From Study Baseline in Computerized Cognitive Battery Domain Score: Identification Test (IDN) Score

  This battery is a series of computerized cognition tests (detection, identification, one card learning, one back and groton maze learning) designed to measure reaction time, visual learning and memory, and executive function/sequencing. IDN test is a measure of visual attention (choice reaction time) and scored for speed of response (mean of the log10 transformed reaction times for correct responses). Total score ranged from 2 to 3.3 log 10 msec. Lower score indicated better performance. Higher change from baseline indicated better performance.

  IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months

• Change From Study Baseline in Computerized Cognitive Battery Domain Score: One Card Learning Test (OCL) Score

  This battery is a series of computerized cognition tests (detection, identification, one card learning, one back and groton maze learning) designed to measure reaction time, visual learning and memory, and executive function/sequencing. OCL test is a measure of visual episodic memory and visual recall test scored using arcsine transformation of the percentage of correct responses (CR). The range for OCL is 0 to 100 percent (%) accuracy; presented as an arcsin transformation, the range is 0 to 1.57. Higher score indicated better performance. Higher change from baseline indicated better performance.

  IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months

• Change From Study Baseline in Computerized Cognitive Battery Domain Score: One Back Test (ONB) Score

  The ONB is a measure of working memory and scored for speed of correct response (mean of the log10-transformed reaction times for correct responses). Total score ranged from 2 to 3.54 log10 msec. Lower score indicated better performance. Higher change from baseline indicated better performance.

  IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months

• Change From Study Baseline in Computerized Cognitive Battery Domain Score: Groton Maze Learning Test (GMLT) Score

  This battery is a series of computerized cognition tests (detection, identification, one card learning, one back and groton maze learning) designed to measure reaction time, visual learning and memory, and executive function/sequencing. GMLT measures executive function; maze/sequencing test, scored for total number of errors. Total score ranged from 0 to 999 number of errors. Lower score indicated better performance. Higher change from baseline indicated better performance.

  IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months

• Change From Study Baseline in Hopkins Verbal Learning Test-Revised (HVLT-R) Score

  The HVLT-R measures performance in verbal memory, learning, and long-term recall in which a list of words is read up to three times. Approximately 20-25 minutes later, a delayed recall trial and a recognition trial are completed. The delayed recall requires free recall of any words remembered. The recognition trial is composed of 24 words, including the 12 target words and 12 false-positives. When scoring the HVLT, the three learning trials are combined to calculate a total recall score (0-36); the delayed recall trial creates the delayed recall score (0-12); the total number of true-positive errors (0-12); and the range of recognition discrimination index is comprised by subtracting the total number of false positives from the total number of true positives. A higher total recall score indicated higher cognition. The range of the recognition discrimination index is -12 to 12. Higher score indicated better performance and higher change from baseline indicated better performance.

  IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months

• Percentage of Participants Based on Columbia-Suicide Severity Rating Scale (C-SSRS) Score

  C-SSRS: interview-based instrument to systematically assess suicidal ideation (SI) and behavior, to assess whether participant experienced any of following: completed suicide, suicide attempt (response of "yes" on "actual attempt"), preparatory acts toward imminent suicidal behavior ("yes" on "preparatory acts or behavior", "aborted attempt" or "interrupted attempt"), suicidal ideation ("yes" on "wish to be dead", "non-specific active suicidal thoughts", "active SI with methods without intent to act or some intent to act, without or with specific plan and intent), any self-injurious behavior with no suicidal intent ("yes" on "has participant engaged in non-suicidal self-injurious behavior"). Here, percentage of participants with \>=1 positive behavior, participants with \>=1 positive ideations; no event were reported.

  IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months

• Number of Participants With Treatment-emergent Adverse Events (TEAEs)

  An adverse event (AE) was any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Any AE occurring at or after the initial administration of study intervention up to end of study was considered as treatment-emergent.

  IND Phase: up to 4 weeks; OP/MA Phase: up to 78 months

• Change From Baseline in Heart Rate

  Change from baseline (predose) in heart rate were reported.

  IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months

• Change From Baseline in Systolic and Diastolic Blood Pressure

  Change from baseline in systolic and diastolic blood pressure were reported.

  IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months

• Change From Baseline in Respiratory Rate

  Change from baseline in respiratory rate were reported.

  IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months

• Change From Baseline in Blood Oxygen Saturation

  Change from baseline in blood oxygen saturation (predose) were reported.

  IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months

Secondary Outcomes (7)

• Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Score

  IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months

• Change From Baseline in Participant-Reported Depressive Symptoms Using the Patient Health Questionnaire - 9 (PHQ-9) Total Score

  IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months

• Change From Baseline in Clinical Global Impression-severity (CGI-S) Score

  IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months

• Change From Baseline in Sheehan Disability Scale (SDS) Total Score

  IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months

• Change From Baseline in Participant-Reported Health-related Quality of Life as Assessed by EuroQol-5 Dimension-5 Level (EQ-5D-5L) Valuation Index Score (VAS)

  IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months

Study Arms (1)

Esketamine Nasal Spray

EXPERIMENTAL

Open-Label Induction Phase: Participants will self-administer with esketamine nasal spray twice per week for 4 weeks as a flexible dose regimen (56 milligram \[mg\] 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 entering from studies ESKETINTRD3001 (NCT02417064), ESKETINTRD3002 (NCT02418585), ESKETINTRD3003 (NCT02493868), ESKETINTRD3004 (NCT02497287), or ESKETINTRD3006 (US sites only) will self-administer esketamine nasal spray (same dose) once weekly. Participants entering from study ESKETINTRD3005 (NCT02422186) will self-administer esketamine nasal spray (28 mg in week 1; 28 or 56 mg in week 2; and 28, 56 or 84 mg in week 3 and 4) once weekly. After Week 4 (starting at Week 5), based on the Investigator's clinical judgment, the dose of esketamine for all participants can be adjusted based upon efficacy and tolerability.

Drug: Esketamine Nasal Spray

Interventions

Esketamine Nasal Spray DRUG

Open-Label Induction Phase: Participants will self-administer with esketamine nasal spray twice per week for 4 weeks as a flexible dose regimen (56 milligram \[mg\] 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 entering from studies ESKETINTRD3001 (NCT02417064), ESKETINTRD3002 (NCT02418585) or ESKETINTRD3006 (US sites only) will self-administer esketamine nasal spray (same dose) once weekly. Participants entering from study ESKETINTRD3005 (NCT02422186) will self-administer esketamine nasal spray (28 mg in week 1; 28 or 56 mg in week 2; and 28, 56 or 84 mg in week 3 and 4) once weekly. After Week 4 (starting at Week 5), based on the Investigator's clinical judgment, the dose of esketamine for all participants can be adjusted based upon efficacy and tolerability.

Also known as: JNJ-54135419

Esketamine Nasal Spray

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• The evaluation of the benefit versus risk of continued esketamine nasal spray 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (173)

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Birmingham, Alabama, United States

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Little Rock, Arkansas, United States

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Garden Grove, California, United States

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Glendale, California, United States

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Oakland, California, United States

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Orange, California, United States

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San Diego, California, United States

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San Rafael, California, United States

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Hartford, Connecticut, United States

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New Haven, Connecticut, United States

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Gainesville, Florida, United States

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Miami, Florida, United States

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Orlando, Florida, United States

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Atlanta, Georgia, United States

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Chicago, Illinois, United States

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Hoffman Estates, Illinois, United States

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Joliet, Illinois, United States

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Maywood, Illinois, United States

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Skokie, Illinois, United States

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Iowa City, Iowa, United States

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Wichita, Kansas, United States

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Lake Charles, Louisiana, United States

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Shreveport, Louisiana, United States

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Baltimore, Maryland, United States

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Gaithersburg, Maryland, United States

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Boston, Massachusetts, United States

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New Bedford, Massachusetts, United States

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Watertown, Massachusetts, United States

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Worcester, Massachusetts, United States

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Rochester Hills, Michigan, United States

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O'Fallon, Missouri, United States

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Saint Charles, Missouri, United States

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Omaha, Nebraska, United States

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Cedarhurst, New York, United States

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New York, New York, United States

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Staten Island, New York, United States

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Hickory, North Carolina, United States

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Cincinnati, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Allentown, Pennsylvania, United States

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Media, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Lincoln, Rhode Island, United States

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Providence, Rhode Island, United States

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Charleston, South Carolina, United States

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Austin, Texas, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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Wichita Falls, Texas, United States

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Charlottesville, Virginia, United States

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Waukesha, Wisconsin, United States

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Banfield, Argentina

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Buenos Aires, Argentina

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Córdoba, Argentina

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La Plata, Argentina

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Mendoza, Argentina

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Rosario, Argentina

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Caulfield, Australia

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Elizabeth Vale, Australia

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Frankston, Australia

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Vienna, Austria

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Aalst, Belgium

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Bruges, Belgium

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Brussels, Belgium

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Heusden-Zolder, Belgium

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Liège, Belgium

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Yvoir, Belgium

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Belo Horizonte, Brazil

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Curitiba, Brazil

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Fortaleza, Brazil

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Passo Fundo, Brazil

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Porto Alegre, Brazil

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Recife, Brazil

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Rio de Janeiro, Brazil

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São Bernardo do Campo, Brazil

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São Paulo, Brazil

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Burgas, Bulgaria

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Kardzhali, Bulgaria

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Pazardzhik, Bulgaria

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Pleven, Bulgaria

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Plovdiv, Bulgaria

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Rousse, Bulgaria

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Sofia, Bulgaria

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Varna, Bulgaria

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Vancouver, British Columbia, Canada

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Kingston, Ontario, Canada

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Ottawa, Ontario, Canada

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Toronto, Ontario, Canada

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Brno, Czechia

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Pilsen, Czechia

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Prague, Czechia

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Tallinn, Estonia

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Tartu, Estonia

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Kuopio, Finland

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Clermont-Ferrand, France

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Douai, France

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Nantes, France

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Nîmes, France

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Paris, France

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Poitiers, France

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Toulon, France

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Berlin, Germany

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Bochum, Germany

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Mainz, Germany

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Mittweida, Germany

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Oranienburg, Germany

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Pfaffenhofen, Germany

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Budapest, Hungary

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Debrecen, Hungary

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Győr, Hungary

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Pécs, Hungary

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Sopron, Hungary

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Szekszárd, Hungary

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Vác, Hungary

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Kaunas, Lithuania

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Kuala Lumpur, Malaysia

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Guadalajara, Mexico

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León, Mexico

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Mexico City, Mexico

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México, Mexico

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Monterrey, Mexico

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San Luis Potosí City, Mexico

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Bełchatów, Poland

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Bialystok, Poland

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Bydgoszcz, Poland

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Gdansk, Poland

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Leszno, Poland

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Lublin, Poland

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Warsaw, Poland

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Bratislava, Slovakia

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Liptovský Mikuláš, Slovakia

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Rimavská Sobota, Slovakia

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Rožňava, Slovakia

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Svidník, Slovakia

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Cape Town, South Africa

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Pretoria, South Africa

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Welgemoed, South Africa

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Gwangju, South Korea

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Seoul, South Korea

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Alcorcón, Spain

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Barcelona, Spain

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Bilbao, Spain

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Madrid, Spain

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Oviedo, Spain

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Palma, Spain

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Pamplona, Spain

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Sabadell, Spain

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Salamanca, Spain

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Sant Boi de Llobregat, Spain

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Torrevieja, Spain

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Vitoria-Gasteiz, Spain

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Zamora, Spain

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Halmstad, Sweden

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Lund, Sweden

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Skövde, Sweden

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Stockholm, Sweden

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Kaohsiung City, Taiwan

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New Taipei City, Taiwan

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Taichung, Taiwan

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Taipei, Taiwan

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Taoyuan District, Taiwan

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Adana, Turkey (Türkiye)

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Ankara, Turkey (Türkiye)

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Bursa, Turkey (Türkiye)

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Istanbul, Turkey (Türkiye)

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Kucukcekmece/Istanbul, Turkey (Türkiye)

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Oanakkale, Turkey (Türkiye)

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Samsun, Turkey (Türkiye)

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Chesterfield, United Kingdom

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Derby, United Kingdom

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London, United Kingdom

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Northampton, United Kingdom

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Oxford, United Kingdom

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Related Publications (4)

• Zaki N, Chen LN, Lane R, Doherty T, Drevets WC, Morrison RL, Sanacora G, Wilkinson ST, Young AH, Lacerda ALT, Paik JW, Popova V, Fu DJ. Safety and efficacy with esketamine in treatment-resistant depression: long-term extension study. Int J Neuropsychopharmacol. 2025 Jun 6;28(6):pyaf027. doi: 10.1093/ijnp/pyaf027.

  PMID: 40319349 DERIVED

• Castro M, Wilkinson ST, Al Jurdi RK, Petrillo MP, Zaki N, Borentain S, Fu DJ, Turkoz I, Sun L, Brown B, Cabrera P. Efficacy and Safety of Esketamine Nasal Spray in Patients with Treatment-Resistant Depression Who Completed a Second Induction Period: Analysis of the Ongoing SUSTAIN-3 Study. CNS Drugs. 2023 Aug;37(8):715-723. doi: 10.1007/s40263-023-01026-3. Epub 2023 Aug 9.

  PMID: 37558912 DERIVED

• Zaki N, Chen LN, Lane R, Doherty T, Drevets WC, Morrison RL, Sanacora G, Wilkinson ST, Popova V, Fu DJ. Long-term safety and maintenance of response with esketamine nasal spray in participants with treatment-resistant depression: interim results of the SUSTAIN-3 study. Neuropsychopharmacology. 2023 Jul;48(8):1225-1233. doi: 10.1038/s41386-023-01577-5. Epub 2023 May 12.

  PMID: 37173512 DERIVED

• Starr HL, Abell J, Larish A, Lewis S, DeMuro C, Gogate J, Jamieson C, Daly E, Zaki N, Kramer M. Self-reported review of the value of esketamine in patients with treatment-resistant depression: Understanding the patient experience in the STRIVE Study. Psychiatry Res. 2020 Nov;293:113376. doi: 10.1016/j.psychres.2020.113376. Epub 2020 Aug 8.

  PMID: 32818917 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Treatment-Resistant

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Results Point of Contact

• Title: Global Medical Head
• Organization: Janssen Research & Development, LLC

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2016
• First Posted: May 25, 2016
• Study Start: June 9, 2016
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2022
• Last Updated: April 29, 2025
• Results First Posted: February 20, 2024

Record last verified: 2025-04

Locations

BR (9); MY (1); GB (5); FI (1); AR (6); SE (4); US (51); LI (1); KR (2); TU (7); BU (8); ES (13); PL (7); TW (5); FR (7); BE (6); CA (4); SL (5); AU (3); HU (7); ME (6); DE (6); ZA (3); CZ (3)