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

Phase 1

• Conditions: Treatment-resistant Major Depression; MedDRA version: 19.0Level: PTClassification code 10057840Term: Major depressionSystem Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2015-003578-34-ES
• Lead Sponsor: Janssen-Cilag International NV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06-22
• Last Update Posted: 29 August 2016

Recruitment & Eligibility

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

Inclusion Criteria

- Based on the prior study the participant is entering 54135419TRD3008 from: a) From ESKETINTRD3001 (NCT02417064) or
ESKETINTRD3002 (NCT02418585) study: Participant has completed the induction phase and 6-month follow up phase;
b) From ESKETINTRD3003 (NCT02493868) study: (1) Participant relapsed during the maintenance phase; or (2) Participant 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 (3) Participant was in the optimization or maintenance phases at the time the study was terminated;
c) From ESKETINTRD3004 (NCT02497287) study: (1) Participant completed the
ESKETINTRD3004 study (that is, Week 52 of the optimization/maintenance phase and the follow up phase); or (2) Participant 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 (3) Participant was in the optimization/maintenance phase at the time the study was terminated;
d) From ESKETINTRD3005 (NCT02422186) study: Participant 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 a non-responder.
-Participant must be medically stable on the basis of physical examination, vital signs, pulse oximetry, and 12-lead Electrocardiogram (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 participant's source documents and initialed by the investigator
-Participant must be medically stable on the basis of clinical laboratory tests performed predose on the day of the first intranasal treatment session. If the results of the serum chemistry panel, hematology, or urinalysis are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant or to be appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and initialed by the investigator
-A woman of childbearing potential must have a negative serum (beta-human chorionic gonadotropin [b-hCG]) predose on the day of the first intranasal treatment session
-During the study (that is, from the first intranasal treatment session) and for a minimum of 1 spermatogenesis cycle (defined as approximately 90 days) after receiving the last dose of intranasal study medication, in addition to the user independent highly effective method of contraception, a man a) who is sexually active with a woman of childbearing potential must agree to use a doublebarrier method of contraception (example, diaphragm or cervical/vault caps plus condom with spermicidal foam/gel/film/cream/suppository); b) who is sexually active with a woman who is pregnant must use a condom; c) must agree not to donate sperm. Alternatively female partners of childbearing potential may be practicing a highly effective method of birth control, example, established use of oral, injected, or implanted hormonal methods of contraception; placement of an intrauterine device (IUD) or intrauterine system (IUS); or male partner steri

Exclusion Criteria

-The evaluation of the benefit versus risk of continued intranasal esketamine treatment is not favorable for the participant in the opinion of the investigator
-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 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)
-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
-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
-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