Ignite Creation Date:
2024-05-06 @ 12:48 PM
Last Modification Date:
2024-10-26 @ 1:04 PM
Study NCT ID:
NCT03852160
Status:
WITHDRAWN
Last Update Posted:
2019-11-26
First Post:
2019-02-12
Brief Title:
A Study of Esketamine Nasal Spray Plus a New Standard-of-care Oral Antidepressant or Placebo Nasal Spray Plus a New Standard-of-care Oral Antidepressant in Adult and Elderly Participants With Treatment-resistant Depression
Sponsor:
Janssen-Cilag International NV
Organization:
Janssen-Cilag International NV
Study Overview
Official Title:
A Randomized Double-Blind Active-Controlled International Multicenter Study to Evaluate the Efficacy Safety and Tolerability of Flexibly-dosed Esketamine Nasal Spray Plus a New Standard-of-care Oral Antidepressant or Placebo Nasal Spray Plus a New Standard-of-care Oral Antidepressant in Adult and Elderly Participants With Treatment-resistant Depression
Status:
WITHDRAWN
Status Verified Date:
2019-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
New design was developed to better fit company strategy a new study has replaced 5413541TRD3011 study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the efficacy of treating participants with treatment-resistant depression TRD who have failed at least 2 and no more than 6 prior antidepressant AD treatments in the current moderate to severe depressive episode with flexibly-dosed esketamine nasal spray plus a newly initiated oral standard-of-care AD compared with placebo nasal spray plus a newly-initiated standard-of-care oral AD in achieving remission and staying relapse-free after remission
Detailed Description:
Depression is a major cause of morbidity and mortality with global estimates of 300 million treated and untreated individuals worldwide In its severe forms depression is the most common diagnosis associated with suicide Esketamine S-ketamine is the S-enantiomer of ketamine Ketamine profoundly affects fast excitatory glutamate transmission increases brain-derived neurotrophic factor release and stimulates synaptogenesis in contrast to conventional antidepressants ADs which are modulatory transmitters The goal of any new antidepressant AD treatment would be the rapid and long-lasting relief of depressive symptoms The study includes screening phase 2 weeks with possible extension up to 4 weeks Induction phase Week 1 to Week 4 Maintenance once-weekly phase Week 5 to Week 8 Maintenance flexible-frequency phase Week 9 to Week 32 and Follow-up phase 2 Weeks Duration Total duration of study will be approximately up to 36 weeks The safety will be monitored throughout the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2018-001890-26 | EUDRACT_NUMBER | None | None |
| 54135419TRD3011 | OTHER | Janssen-Cilag International NV | None |