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CompletedPhase 3Results posted

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

NCT02497287 · SUSTAIN-2 · Janssen Research & Development, LLC

Closed to entry
Status
Not accepting participants
Phase 3
Phase
802
Target enrolment
109
Study sites
13 US states

What it is testing

Summary

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).

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

  • Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)

    Measured over Up to End of Follow up Phase (Week 56)

  • Percentage of Participants With Cystitis, Urinary Tract Infections, Renal and Urinary Tract Symptoms, Renal and Urinary Disorders

    Measured over Up to End of Follow up Phase (Week 56)

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

    Measured over Baseline (IND) up to the Endpoint (last post-baseline assessment value during 52 weeks of Optimization/Maintenance [OP/MA] Phase)

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

    Measured over Baseline (IND) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA Phase)

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

    Measured over Baseline (IND) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA Phase)

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

    Measured over Baseline (IND) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA Phase)

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

    Measured over Baseline (IND) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA Phase)

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

    Measured over Baseline (IND) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA Phase)

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

    Measured over Baseline (IND) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA Phase)

  • Change From Baseline in Hopkins Verbal Learning Test-Revised (HVLT-R) Score: Number of Words Recalled

    Measured over Baseline (IND) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA Phase)

  • Change From Baseline in Hopkins Verbal Learning Test-Revised (HVLT-R) Score: Recognition Discrimination Index

    Measured over Baseline (IND) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA phase)

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: 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

Where

109 study sites

FacilityCityRegionCountry
-New HavenConnecticutUnited States
-MiamiFloridaUnited States
-MariettaGeorgiaUnited States
-Iowa CityIowaUnited States
-WichitaKansasUnited States
-BaltimoreMarylandUnited States
-WatertownMassachusettsUnited States
-CedarhurstNew YorkUnited States
-New YorkNew YorkUnited States
-Staten IslandNew YorkUnited States
-CincinnatiOhioUnited States
-AllentownPennsylvaniaUnited States
-CharlestonSouth CarolinaUnited States
-DallasTexasUnited States
-Wichita FallsTexasUnited States
-RichlandWashingtonUnited States
-Banfield-Argentina
-Buenos Aires-Argentina
-Córdoba-Argentina
-La Plata-Argentina
-Mendoza-Argentina
-Rosario-Argentina
-Adelaide-Australia
-Caulfield-Australia
-Frankston-Australia
-Melbourne-Australia
-Innsbruck-Austria
-Vienna-Austria
-Bruges-Belgium
-Hasselt-Belgium
-Belo Horizonte-Brazil
-Fortaleza-Brazil
-Recife-Brazil
-Rio de Janeiro-Brazil
-Santo André-Brazil
-São José do Rio Preto-Brazil
-São Paulo-Brazil
-Burgas-Bulgaria
-Kardzhali-Bulgaria
-Kazanlak-Bulgaria
-Pazardzhik-Bulgaria
-Pleven-Bulgaria
-Plovdiv-Bulgaria
-Rousse-Bulgaria
-Sofia-Bulgaria
-Varna-Bulgaria
-Helsinki-Finland
-Kuopio-Finland
-Paris-France
-Poitiers-France
-Toulon-France
-Tours-France
-Berlin-Germany
-Bochum-Germany
-Oranienburg-Sachsenhausen-Germany
-Kaunas-Lithuania
-Šilutė-Lithuania
-Vilnius-Lithuania
-Ipoh-Malaysia
-Johor Bahru-Malaysia
-Kuala Lumpur-Malaysia
-Acapulco-Mexico
-Durango-Mexico
-Mexico City-Mexico
-México-Mexico
-Monterrey-Mexico
-Gdansk-Poland
-Cape Town-South Africa
-Garsfontein-South Africa
-Pretoria-South Africa
-Gwangju-South Korea
-Gyeonggi-do-South Korea
-Seoul-South Korea
-Badajoz-Spain
-Bilbao-Spain
-Madrid-Spain
-Ourense-Spain
-Oviedo-Spain
-Sant Boi de Llobregat-Spain
-Torrevieja-Spain

Showing the first 80 of 109

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.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT02497287 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