A Long-term Safety Study of Intranasal Esketamine in Treatment-resistant Depressio
- Conditions
- Treatment-resistant Major DepressionMedDRA version: 21.1Level: PTClassification code 10057840Term: Major depressionSystem Organ Class: 10037175 - Psychiatric disordersTherapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
- Registration Number
- EUCTR2015-003578-34-LT
- Lead Sponsor
- Janssen-Cilag International NV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 330
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. 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:
a. Not of childbearing potential defined as:
-postmenopausal
-permanently sterile
b. Of childbearing potential and practicing a highly effective method of contraception (failure rate of <1% per year when used consistently and
correctly).
Examples of highly effective contraceptives include
-user-independent methods:
implantable progestogen-only hormone contraception associated with inhibition of ovulation; intrauterine device (IUD); intrauterine hormonereleasing
system (IUS); vasectomized partner; sexual abstinence (sexual abstinence is considered a highly effec
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
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method