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CompletedPhase 3Results posted

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

NCT02782104 · SUSTAIN-3 · Janssen Research & Development, LLC

Closed to entry
Status
Not accepting participants
Phase 3
Phase
1,148
Target enrolment
173
Study sites
25 US states

What it is testing

Summary

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

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

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

    Measured over 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

    Measured over 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

    Measured over 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

    Measured over 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

    Measured over 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

    Measured over 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

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

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

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

  • Change From Baseline in Heart Rate

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

  • Change From Baseline in Systolic and Diastolic Blood Pressure

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

  • Change From Baseline in Respiratory Rate

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

  • Change From Baseline in Blood Oxygen Saturation

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

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years
Ages
All
Sex
Not accepted
Healthy volunteers
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 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

Where

173 study sites

FacilityCityRegionCountry
-BirminghamAlabamaUnited States
-Little RockArkansasUnited States
-Garden GroveCaliforniaUnited States
-GlendaleCaliforniaUnited States
-OaklandCaliforniaUnited States
-OrangeCaliforniaUnited States
-San DiegoCaliforniaUnited States
-San RafaelCaliforniaUnited States
-HartfordConnecticutUnited States
-New HavenConnecticutUnited States
-GainesvilleFloridaUnited States
-MiamiFloridaUnited States
-OrlandoFloridaUnited States
-AtlantaGeorgiaUnited States
-ChicagoIllinoisUnited States
-Hoffman EstatesIllinoisUnited States
-JolietIllinoisUnited States
-MaywoodIllinoisUnited States
-SkokieIllinoisUnited States
-Iowa CityIowaUnited States
-WichitaKansasUnited States
-Lake CharlesLouisianaUnited States
-ShreveportLouisianaUnited States
-BaltimoreMarylandUnited States
-GaithersburgMarylandUnited States
-BostonMassachusettsUnited States
-New BedfordMassachusettsUnited States
-WatertownMassachusettsUnited States
-WorcesterMassachusettsUnited States
-Rochester HillsMichiganUnited States
-O'FallonMissouriUnited States
-Saint CharlesMissouriUnited States
-OmahaNebraskaUnited States
-CedarhurstNew YorkUnited States
-New YorkNew YorkUnited States
-Staten IslandNew YorkUnited States
-HickoryNorth CarolinaUnited States
-CincinnatiOhioUnited States
-Oklahoma CityOklahomaUnited States
-AllentownPennsylvaniaUnited States
-MediaPennsylvaniaUnited States
-PhiladelphiaPennsylvaniaUnited States
-LincolnRhode IslandUnited States
-ProvidenceRhode IslandUnited States
-CharlestonSouth CarolinaUnited States
-AustinTexasUnited States
-DallasTexasUnited States
-HoustonTexasUnited States
-Wichita FallsTexasUnited States
-CharlottesvilleVirginiaUnited States
-WaukeshaWisconsinUnited States
-Banfield-Argentina
-Buenos Aires-Argentina
-Córdoba-Argentina
-La Plata-Argentina
-Mendoza-Argentina
-Rosario-Argentina
-Caulfield-Australia
-Elizabeth Vale-Australia
-Frankston-Australia
-Vienna-Austria
-Aalst-Belgium
-Bruges-Belgium
-Brussels-Belgium
-Heusden-Zolder-Belgium
-Liège-Belgium
-Yvoir-Belgium
-Belo Horizonte-Brazil
-Curitiba-Brazil
-Fortaleza-Brazil
-Passo Fundo-Brazil
-Porto Alegre-Brazil
-Recife-Brazil
-Rio de Janeiro-Brazil
-São Bernardo do Campo-Brazil
-São Paulo-Brazil
-Burgas-Bulgaria
-Kardzhali-Bulgaria
-Pazardzhik-Bulgaria
-Pleven-Bulgaria

Showing the first 80 of 173

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record. The registry also holds the most current version of everything above.

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NCT02782104 on ClinicalTrials.gov →

Last updated in the registry 2025-04-29. Registry records change; this page reflects the data build of 2026-10-06.

Related

Where this trial sits