A Long-term Safety Study of Intranasal Esketamine in Treatment-resistant Depressio

Phase 1

• Conditions: Treatment-resistant Major Depression; MedDRA version: 21.1Level: PTClassification code 10057840Term: Major depressionSystem Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2015-003578-34-IT
• Lead Sponsor: JANSSEN CILAG INTERNATIONAL NV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-01-05
• Last Update Posted: 11 January 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 330

Inclusion Criteria

Criterion modified per Amendment 1
1.1 Based on the prior study the subject is entering 54135419TRD3008 from: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 phase; or
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. Criterion modified per Amendment 1
3.1 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.

Additional Inclusion Criteria can be found in Protocol Section 4.1
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1018
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 122

Exclusion Criteria

1. The evaluation of the benefit versus risk of continued nasal spray esketamine 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 (C-SSRS) [corresponding to a response of Yes” on Item 44 (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 arbiturates, 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified