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-CZ
• Lead Sponsor: Janssen-Cilag International NV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-02-17
• Last Update Posted: 30 January 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 330

Inclusion Criteria

1. 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. .
4. Criterion modified per Amendment 1
4.1 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:
a. Not of childbearing potential defined as:
? postmenopausal
A postmenopausal state is defined as no menses for 12 months without
an alternative medical cause. A high follicle stimulating hormone (FSH)
level (>40 IU/L or mIU/mL in the postmenopausal range) will be used
to confirm a postmenopausal state in women not using hormonal
contraception or hormonal replacement therapy, however in the absence
of 12 months of amenorrhea, a single FSH meas

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
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
Additional Exclusion Criteria can be found in Protocol section 4.2.

Study & Design

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