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Clinical Trials/EUCTR2015-003578-34-FI
EUCTR2015-003578-34-FIActive, not recruitingPhase 1

An Open-label Long-term Extension Safety Study of Esketamine Nasal Spray in Treatment-resistant Depression - SUSTAIN-3

Janssen-Cilag International NV0 sites330 target enrollmentStarted: March 23, 2017Last updated:
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Conditions

Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Enrollment
330
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

Inclusion Criteria

  • •1. Based on the prior study the subject is entering 54135419TRD3008
  • •a. From ESKETINTRD3001 or ESKETINTRD3002 study:
  • •i. Subject has completed the induction phase and the 2-week follow up
  • •phase visit; or
  • •ii. Subject completed the induction phase and was a responder and study
  • •ESKETINTRD3003 is terminated.
  • •b. From ESKETINTRD3003 study:
  • •i. Subject relapsed during the maintenance phase; or ii. Subject 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
  • •iii. Subject was in the optimization or maintenance phases at the time
  • •the study was terminated; or
  • •iv. At Week 16 of Optimization, the subject was not eligible to proceed to
  • •the Maintenance phase and sponsor has approved subject's entry into
  • •54135419TRD3008; or
  • •v. Subject was in the induction phase and after completion of induction
  • •phase was determined to not meet response criteria, and sponsor has
  • •approved subject's entry into 54135419TRD3008.
  • •c. From ESKETINTRD3004 study:
  • •i. Subject completed ESKETINTRD3004 study optimization/maintenance
  • •ii. Subject 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
  • •iii. Subject was in the optimization/maintenance phase at the time the
  • •study was terminated; or
  • •iv. Subject was in the induction phase and did not meet criteria for
  • •response, and sponsor has approved subject's entry into
  • •54135419TRD3008.
  • •d. From ESKETINTRD3005 study: Subject 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):
  • •i. Subject completed the induction phase and was a responder; or
  • •ii. Subject completed the induction phase and did not meet the response
  • •criteria and sponsor has approved subject's entry into
  • •54135419TRD3008.
  • •2. Subject must be medically stable on the basis of physical examination,
  • •vital signs (including blood pressure), pulse oximetry, and 12-lead 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 subject's source documents and
  • •initialed by the investigator.
  • •3. Subject 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. .
  • •4. Contraceptive use by men or women should be consistent with local regulations regarding the use of contraceptive methods for subjects participating in clinical studies.
  • •A woman must be either:
  • +7 more not shown

Exclusion Criteria

  • •1. 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
  • •2. 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 (CSSRS)
  • •[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)
  • •3. Subject has a neurodegenerative disorder (eg, Alzheimer's disease,
  • •vascular dementia, Parkinson's disease), or evidence of mild cognitive
  • •impairment (MCI).
  • •4. 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
  • •5. 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
  • •6. Participant has taken any prohibited therapies that would not permit
  • •administration of the first intranasal treatment session
  • •Additional Exclusion Criteria can be found in Protocol section 4.2.

Investigators

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Phase 1
A Long-term Safety Study of Intranasal Esketamine in Treatment-resistant DepressioTreatment-resistant Major DepressionMedDRA version: 19.0Level: PTClassification code 10057840Term: Major depressionSystem Organ Class: 10037175 - Psychiatric disorders
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A Long-term Safety Study of Esketamine Nasal Spray in Treatment-resistant DepressioTreatment-resistant Major DepressionMedDRA version: 21.1Level: PTClassification code 10057840Term: Major depressionSystem Organ Class: 10037175 - Psychiatric disorders
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A Long-term Safety Study of Intranasal Esketamine in Treatment-resistant DepressioTreatment-resistant Major DepressionMedDRA version: 21.1Level: PTClassification code 10057840Term: Major depressionSystem Organ Class: 10037175 - Psychiatric disorders
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A Long-term Safety Study of Intranasal Esketamine in Treatment-resistant DepressioTreatment-resistant Major DepressionMedDRA version: 21.1Level: PTClassification code 10057840Term: Major depressionSystem Organ Class: 10037175 - Psychiatric disorders
EUCTR2015-003578-34-SKJanssen-Cilag International NV330
A Long-term Safety Study of Intranasal... | Clinical Trial